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Regulatory Intelligence

Navigate the Regulatory Landscape and Make Smart Decisions

Stay current with ever-changing regulations, with routine updates from ClinChoice. Use the reference chart below to follow regulatory updates on a variety of medical topics from health authorities and countries worldwide. Have questions or want to talk to an expert? Contact us to schedule a consultation.

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Country/Region Health Authority Date of Publishing Product Type Topic Domain URL
Australia Therapeutic Goods Administration 17-8-22 Medical Device Regulation of software based medical devices Regulatory Visit Page
USA Food and Drug Administration 3-8-22 Medical Device Sterilization for Medical Devices Regulatory Visit Page
Europe European Medicines Agency 27-7-22 Drug EMA response to the monkeypox public health emergency Regulatory Visit Page
USA Food and Drug Administration 25-7-22 Drug Proposed Rule on Revising the National Drug Code Format Labeling Visit Page
USA Food and Drug Administration 25-7-22 Medical Device Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices Regulatory Visit Page
USA Food and Drug Administration 22-7-22 Drug FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health Regulatory Visit Page
Europe European Medicines Agency 21-7-22 Drug ICH Guideline M12 on drug interaction studies (draft guidance) Clinical Visit Page
Australia Therapeutic Goods Administration 20-7-22 Drug Nitrosamine impurities in medicines - Information for sponsors and manufacturers Regulatory Visit Page
USA Food and Drug Administration 18-7-22 Medical Device Tracking Your Premarket Submission’s Progress (Progress Tracker) Regulatory Visit Page
Europe European Medicines Agency 15-7-22 Drug Towards better prevention of medicine shortages in the EU Regulatory Visit Page
Europe European Commission 14-7-22 Biologics Questions and answers on the proposal for a new legislation on blood, tissues, and cells Regulatory Visit Page
Europe European Commission 13-7-22 Medical Device MDCG 2022-12 - Harmonized administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR) Regulatory Visit Page
Australia Therapeutic Goods Administration 12-7-22 Drug Import, Advertising and Supply Compliance Priorities 2022-23 Regulatory Visit Page
Europe European Medicines Agency 12-7-22 Drug Information about the raw data proof-of-concept pilot for industry Clinical Visit Page
India Central Drugs Standard Control Organisation 11-7-22 Medical Device Clarification on medical devices quality certificates Regulatory Visit Page
Europe European Medicines Agency 11-7-22 Drug Concept paper on the revision of the guideline on the chemistry of active substances Regulatory Visit Page
Europe European Medicines Agency 11-7-22 Vaccine ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 11-7-22 Drug Proposed warning and advisory statement for ocular decongestants used for eye redness and/or minor eye irritation: Do not use in children under 12 years of age Safety Visit Page
Europe European Medicines Agency 8-7-22 Drug Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimize risk of meningioma Pharmacovigilance Visit Page
Europe European Medicines Agency 8-7-22 Drug List of the “main therapeutic groups” (MTGs) in crisis preparedness Regulatory Visit Page
India Central Drugs Standard Control Organisation 7-7-22 Medical Device Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) (draft guidance) Regulatory Visit Page
India Central Drugs Standard Control Organisation 7-7-22 Medical Device Guidance on post-market surveillance of In-Vitro Diagnostic Medical Device (draft guidance) Regulatory Visit Page
India Central Drugs Standard Control Organisation 7-7-22 Medical Device Guidance on Stability Studies of In-vitro Diagnostic Medical Device (draft guidance) Regulatory Visit Page
Europe European Commission 4-7-22 Medical Device Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council Regulatory Visit Page
Australia Therapeutic Goods Administration 4-7-22 Biologics Report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' - TGA response Regulatory Visit Page
Europe European Medicines Agency 1-7-22 Drug Quality of medicines questions and answers: Part 2 Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Identifying Trading Partners Under the Drug Supply Chain Security Act (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Changes to Disposable Manufacturing Materials: Questions and Answers Quality Visit Page
USA Food and Drug Administration 1-7-22 Drug Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings Clinical Visit Page
USA Food and Drug Administration 1-7-22 Drug Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format Labeling Visit Page
The Philippines Philippines FDA 1-7-22 Medical Device Amendment to FDA Circular NO. 2017-013, entitled, “guidelines on the issuance of clearance for customs release (CFCR) of radiation devices Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Evaluation of Therapeutic Equivalence (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding” (draft guidance) Labeling Visit Page
USA Food and Drug Administration 1-7-22 Drug and Biological Product General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Clinical Visit Page
Europe European Commission 1-7-22 Medical Device First Spanish group designated under MDR Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Conducting Remote Regulatory Assessments Questions and Answers (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Orange Book Questions and Answers Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug and Biological Product Real-Time Oncology Review (RTOR) (draft guidance) Regulatory Visit Page
Malaysia National Pharmaceutical Regulatory Agency 1-7-22 Drug Malaysian variation guideline for pharmaceutical products Regulatory Visit Page
USA Food and Drug Administration 30-6-22 Medical Device General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma Regulatory Visit Page
Europe European Medicines Agency 28-6-22 Drug Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability  Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 27-6-22 Drug Outcome of the consultation on the proposed warning and advisory statements relating to harm of long-term use and overuse of stimulant laxatives Labeling Visit Page
Australia Therapeutic Goods Administration 27-6-22 Medical Device Clinical evidence guidelines for medical devices Clinical Visit Page
UK Medicines and Healthcare products Regulatory Agency 27-6-22 Medical Device UK to strengthen regulation of medical devices to protect patients Regulatory Visit Page
USA Food and Drug Administration 27-6-22 Drug Nonprescription Drug Product with an Additional Condition for Nonprescription Use Regulatory Visit Page
USA Food and Drug Administration 24-6-22 Drug Considerations for the Development of Oligonucleotide Therapeutics (draft guidance) Clinical Visit Page
Malaysia Medical Device Authority 24-6-22 Medical Device Medical device guidance document licensing for establishment Regulatory Visit Page
The Philippines Philippines FDA 23-6-22 Drug Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price (MRP) Labeling Visit Page
USA Food and Drug Administration 23-6-22 Drug Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 23-6-22 Drug Assessing the Effects of Food on Drugs in Investigational New Drugs and New Drug Applications—Clinical Pharmacology Considerations Clinical Visit Page
USA Food and Drug Administration 23-6-22 Drug and Biological Product Considerations for Rescinding Breakthrough Therapy Designation Regulatory Visit Page
USA Food and Drug Administration 21-6-22 Medical Device Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures Clinical Visit Page
Europe European Commission 20-6-22 Medical Device Tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices Regulatory Visit Page
Europe European Commission 20-6-22 Medical Device Fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices Regulatory Visit Page
Europe European Medicines Agency 17-6-22 Medical Device Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics Regulatory Visit Page
USA Food and Drug Administration 16-6-22 Biologics Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (draft guidance) Regulatory Visit Page
The Philippines Philippines FDA 16-6-22 Drug and Biological Product Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 “Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals Regulatory Visit Page
USA Food and Drug Administration 16-6-22 Medical Device Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions Regulatory Visit Page
Europe European Medicines Agency 15-6-22 Vaccine Start of rolling review for adapted Comirnaty COVID-19 vaccine Regulatory Visit Page
USA Food and Drug Administration 15-6-22 Drug Q9(R1) Quality Risk Management; International Council for Harmonization (draft guidance) Quality Visit Page
Ireland Health Products Regulatory Authority 15-6-22 Medical Device Guide to Performance Studies Conducted in Ireland Clinical Visit Page
India Central Drugs Standard Control Organisation 14-6-22 Drug Draft proposal to include bar codes or QR codes for identified medicinal products Labeling Visit Page
USA Food and Drug Administration 14-6-22 Drug Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (Draft Guidance) Clinical Visit Page
Europe European Commission 13-6-22 Medical Device MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements Regulatory Visit Page
The Philippines Philippines FDA 10-6-22 Drug Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes Regulatory Visit Page
Malaysia Medical Device Authority 8-6-22 Medical Device Guideline for re-registration of registered medical device Regulatory Visit Page
Italy Italian Medicines Agency 7-6-22 Drug Launch of new Pharmacovigilance Network Pharmacovigilance Visit Page
USA Food and Drug Administration 7-6-22 Medical Device Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices--Questions and Answers (Revised); Withdrawal of Guidance Regulatory Visit Page
USA Food and Drug Administration 6-6-22 Drug and Biological Product Assessment of the Appropriate Net Container Content for Injectable Drug and Biological Products Regulatory Visit Page
USA Food and Drug Administration 6-6-22 Medical Device Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation Regulatory Visit Page
Europe European Commission 3-6-22 Medical Device EFPIA statement on the concerning impact of the In Vitro Diagnostic Regulation Clinical Visit Page
France French National Agency for the Safety of Medicines and Health Products 2-6-22 Drug New edition of good pharmacovigilance practices Pharmacovigilance Visit Page
Europe European Commission 2-6-22 Drug Questions and answers - Complex clinical trials Clinical Visit Page
Switzerland The Swiss Agency for Therapeutic Products 1-6-22 Drug Applications for clinical trials for medicinal products Clinical Visit Page
Europe European Commission 1-6-22 Medical Device Draft standardization request amending Implementing Decision C (2021) 2406 of 14.4.2021 Regulatory Visit Page
Japan Pharmaceuticals and Medical Devices Agency 1-6-22 Drug-Device Combination Pharmaceuticals and Medical Devices Safety Information Safety Visit Page
USA Food and Drug Administration 1-6-22 Medical Device Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals Regulatory Visit Page
USA Food and Drug Administration 1-6-22 Drug and Biological Product Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment Clinical Visit Page
The Philippines Philippines FDA 1-6-22 Drug Implementing Guidelines on the Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines Regulatory Visit Page
Australia Therapeutic Goods Administration 1-6-22 Medical Device Uniform Recall Procedure for Therapeutic Goods (URPTG) Regulatory Visit Page
USA Food and Drug Administration 1-6-22 Drug and Biological Product Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment Clinical Visit Page
Ireland Health Products Regulatory Authority 30-5-22 Drug Stakeholder Consultation on Registration of Processes exempted under Article 61(5) and applicable requirements under Article 61(6) of the CTR Clinical Visit Page
Australia Therapeutic Goods Administration 27-5-22 Medical Device Seasonal Influenza Rapid Antigen Self-tests and Combination tests Clinical performance requirements and risk mitigation strategies Clinical Visit Page
Switzerland The Swiss Agency for Therapeutic Products 26-5-22 Medical Device Performance studies with IVD Clinical Visit Page
Switzerland The Swiss Agency for Therapeutic Products 26-5-22 Medical Device New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022 Clinical Visit Page
USA Food and Drug Administration 20-5-22 Drug Product-Specific Guidance’s; Draft and Revised Draft Guidance’s for Industry; Availability Regulatory Visit Page
Europe European Medicines Agency 19-5-22 Drug Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address pediatric-specific clinical data requirements Clinical Visit Page
Europe European Medicines Agency 19-5-22 Drug Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections Clinical Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 18-5-22 Drug Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodies Regulatory Visit Page
India Central Drugs Standard Control Organisation 18-5-22 Medical Device Suspension and cancellation of medical device licenses Regulatory Visit Page
International Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) 16-5-22 Drug PIC/S work plan for 2022 Regulatory Visit Page
Europe European Commission 11-5-22 Medical Device Amending Implementing Decision (EU) 2021/1182 as regards harmonized standards for quality management systems, sterilization, and application of risk management to medical devices Quality Visit Page
Europe European Medicines Agency 11-5-22 Drug Public Consultation Concerning the Physical Attendance and The Location of Personal Residency of The Qualified Person Pharmacovigilance Visit Page
Europe European Medicines Agency 10-5-22 Drug Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes Clinical Visit Page
Australia Therapeutic Goods Administration 9-5-22 Drug Independent expert report on the risks of intentional self-poisoning with paracetamol Regulatory Visit Page
USA Food and Drug Administration 6-5-22 Medical Device Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program (draft guidance) Regulatory Visit Page
Europe European Medicines Agency 5-5-22 Drug Good Clinical Practice (GCP) inspection procedures – annexures updated Clinical Visit Page
USA Food and Drug Administration 4-5-22 Drug FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease Regulatory Visit Page
Europe European Commission 4-5-22 Medical Device MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR Regulatory Visit Page
Denmark Danish Medicines Agency 3-5-22 Drug New executive order raises fees in the area of the Danish Medicines Agency Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Biologics Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy (draft guidance) Regulatory Visit Page
The Philippines Philippines FDA 2-5-22 Drug Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017 Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 2-5-22 Drug Questions and answers on the packaging and labelling requirements for medicinal products intended to prevent or combat COVID-19 Labeling Visit Page
USA Food and Drug Administration 2-5-22 Biologics Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Drug Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies Guidance for Industry (draft guidance) Clinical Visit Page
USA Food and Drug Administration 2-5-22 Drug Risk Management Plans to Mitigate the Potential for Drug Shortages (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Biologics Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Drug Benefit-Risk Considerations for Product Quality Assessments (draft guidance) CMC Visit Page
USA Food and Drug Administration 2-5-22 Drug Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors Safety Visit Page
Europe European Commission 2-5-22 Medical Device MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 Regulatory Visit Page
The Philippines Philippines FDA 2-5-22 Drug Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines (draft guidance) Clinical Visit Page
USA Food and Drug Administration 2-5-22 Drug Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production Regulatory Visit Page
The Philippines Philippines FDA 2-5-22 Medical Device Good Storage and Distribution Practices for Medical Devices (draft guidance) Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 2-5-22 Drug Review of Fees payable under the Medicines Act 1981 Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Drug Importation of Prescription Drugs Final Rule Questions and Answers Regulatory Visit Page
Australia Therapeutic Goods Administration 29-4-22 Drug Proposed amendments to the Poisons Standard – ACCS, ACMS and joint ACCS/ACMS meetings Regulatory Visit Page
USA Food and Drug Administration 29-4-22 Drug Crohn’s Disease: Developing Drugs for Treatment (draft guidance) Clinical Visit Page
USA Food and Drug Administration 29-4-22 Drug Ulcerative Colitis: Developing Drugs for Treatment (draft guidance) Clinical Visit Page
India Central Drugs Standard Control Organisation 28-4-22 Drug Procedure for regularization of FDCs Regulatory Visit Page
Malaysia Medical Device Authority 1-4-22 Medical Device Guidance on the rules of classification for general medical devices Regulatory Visit Page
International The International Council for Harmonisation 31-3-22 Drug Considerations with respect to future MIDD related guidelines - output from ich model-informed drug development (MIDD) Regulatory Visit Page
The Philippines Philippines FDA 3-2-22 Vaccine Amendment to FDA Circular No. 2020-029 entitled “Guidance on Applications for the Conduct of COVID-19 Clinical Trials Clinical Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 15-4-21 Drug Outcome of the consultation on the proposed changes to paracetamol warning and advisory statements Labeling Visit Page
Switzerland The Swiss Agency for Therapeutic Products 1-4-21 Medical Device New requirements and changes to authorisation practice as of May 2021 Registration Visit Page
USA Food and Drug Administration 25-3-21 Drug Upcoming Product-Specific Guidances for Complex Generic Drug Product Development Registration Visit Page
Europe European Commission 24-3-21 Vaccine New procedure to facilitate and speed up approval of adapted vaccines against Covid-19 variants Registration Visit Page
The Philippines Philippines FDA 23-3-21 Vaccine Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection Registration Visit Page
UK Medicines and Healthcare products Regulatory Agency 23-3-21 Drug-Device Combination MHRA pilots patient involvement in new applications Registration Visit Page
UK Medicines and Healthcare products Regulatory Agency 19-3-21 Drug-Device Combination Guidance for industry on MHRA's expectations for return to UK on-site inspections General Visit Page
USA Food and Drug Administration 17-3-21 FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premark Review Process Registration Visit Page
Europe European Medicines Agency 17-3-21 Drug SWP response to CMDh questions on chlorobutanol General Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 17-3-21 Drug Rapid implementation of the revised sartan monographs on 1 April 2021 Registration Visit Page
USA Food and Drug Administration 16-3-21 Medical Device Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions Regulatory Visit Page
Europe European Medicines Agency 15-3-21 Vaccine EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update Safety Visit Page
India National Pharmaceutical Pricing Authority 12-3-21 Medical Device Change in medical device pricing General Visit Page
Canada Health Canada 12-3-21 Drug "Electronic media in prescription drug labelling" Labeling Visit Page
Europe European Medicines Agency 12-3-21 Vaccine Labelling flexibilities for COVID-19 therapeutics Labeling Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 11-3-21 Drug How CEP holders can avoid the rejection of notifications Registration Visit Page
Europe European Commission 10-3-21 Vaccine "Guidance on state of the art of COVID-19 rapid antibody tests" General Visit Page
Australia Therapeutic Goods Administration 10-3-21 Vaccine COVID-19 vaccines - safety and effectiveness in older adults Safety Visit Page
India Central Drugs Standard Control Organisation 10-3-21 Vaccine Recommendations of the SEC meeting to examine COVID-19 related proposal under accelerated approval process Registration Visit Page
Ireland Health Products Regulatory Authority 9-3-21 Drug Good Distribution Practice of Medicinal Products for Human Use General Visit Page
UK Medicines and Healthcare products Regulatory Agency 9-3-21 Drug Importing medicines into Northern Ireland before 31 December 2021 Regulatory Visit Page
Australia Therapeutic Goods Administration 9-3-21 Medical Device IMDRF consultation: Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews Registration Visit Page
Ireland Health Products Regulatory Authority 9-3-21 Drug-Device Combination "Guide to New Applications and Variations to Wholesale Distribution Authorisations" Regulatory Visit Page
Europe European Commission 5-3-21 Drug Handling of duplicate marketing authorisation applications of pharmaceutical products under Article 82(1) of Regulation (EC) No 726/2004 Registration Visit Page
USA Food and Drug Administration 4-3-21 Vaccine COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 4-3-21 Vaccine Guidance on strain changes in authorised COVID-19 vaccines General Visit Page
Europe European Commission 3-3-21 Drug "Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices" General Visit Page
Europe European Medicines Agency 3-3-21 Drug EMA issues advice on use of antibody combination (bamlanivimab / etesevimab) General Visit Page
USA Food and Drug Administration 3-3-21 Data Modernization Action Plan Regulatory Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 1-3-21 Drug Revision of CEPs referring to one of the "sartan” monographs following their rapid implementation Regulatory Visit Page
Malaysia National Pharmaceutical Regulatory Agency 1-3-21 Drug Guidance Notes Updated API information for product registration Regulatory Visit Page
Australia Therapeutic Goods Administration 26-2-21 Medical Device Consultation: Proposed regulatory options for medical devices containing nanomaterials (for comments) Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 26-2-21 Drug First Innovation Passport awarded to help support development and access to cutting-edge medicines Registration Visit Page
Australia Therapeutic Goods Administration 25-2-21 Medical Device Regulatory changes for software based medical devices Registration Visit Page
Australia Therapeutic Goods Administration 24-2-21 Drug-Device Combination The TGA's risk management approach Safety Visit Page
Europe European Medicines Agency 23-2-21 Vaccine "Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2" Registration Visit Page
Europe European Medicines Agency 22-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
Europe European Medicines Agency 22-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
Europe European Medicines Agency 22-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
Europe European Medicines Agency 22-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
Europe European Medicines Agency 22-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
USA Food and Drug Administration 22-2-21 Drug-Device Combination FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants General Visit Page
USA Food and Drug Administration 19-2-21 Medical Device Pulse Oximeter Accuracy and Limitations: FDA Safety Communication Safety Visit Page
Malaysia National Pharmaceutical Regulatory Agency 18-2-21 Drug-Device Combination Guidance Document Foreign GMP Inspection General Visit Page
UK Medicines and Healthcare products Regulatory Agency 17-2-21 Drug-Device Combination How investigators and sponsors should manage clinical trials during COVID-19 General Visit Page
USA Food and Drug Administration 16-2-21 Medical Device "Medical Device User Fees; Stakeholder Meetings on Medical Device User Fee Amendments of Fiscal Years 2023 to 2027 Reauthorization; Request for Notification of Stakeholder Intention to Participate" General Visit Page
Europe European Commission 15-2-21 Medical Device Management of Legacy Devices MDR EUDAMED General Visit Page
India National Pharmaceutical Pricing Agency 12-2-21 Drug Application for retail price fixation of new drugs through email only General Visit Page
Europe European Medicines Agency 11-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
Denmark Danish Medicines Agency 10-2-21 Vaccine Danish Medicines Agency expands capacity for safety monitoring of Covid-19 vaccines Safety Visit Page
UK Medicines and Healthcare products Regulatory Agency 9-2-21 Drug Access New Active Substance (NAS) Work Sharing Initiative General Visit Page
USA Food and Drug Administration 4-2-21 Vaccine FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data Labeling Visit Page
Europe European Medicines Agency 4-2-21 Drug Guidance on the management of clinical trials during the Covid-19 (coronavirus) pandemic Clinical Visit Page
International World Health Organization 3-2-21 Drug WHO announces updated critical concentrations for susceptibility testing to rifampicin General Visit Page
Europe European Medicines Agency 3-2-21 Drug "Questions and Answers on the Pilot Project 'OPEN' - Opening our Procedures at EMA to Non-EU authorities" Registration Visit Page
Europe European Medicines Agency 3-2-21 Drug Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with revision 3 of Module XVI on risk minimization measures and its Addendum II on methods for their effectiveness evaluation for public consultation Safety Visit Page
Europe European Medicines Agency 2-2-21 Drug Draft toolbox guidance on scientific elements and 5 regulatory tools to support quality data packages for 6 PRIME marketing authorization applications Registration Visit Page
USA Food and Drug Administration 1-2-21 Vaccine Guidance for Industry - Development of Monoclonal Antibody Products Targeting SARSCoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency Clinical Visit Page
Australia Therapeutic Goods Administration 1-2-21 Vaccine COVID-19 vaccine safety monitoring plan Safety Visit Page
UK Medicines and Healthcare products Regulatory Agency 1-2-21 Drug Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) Safety Visit Page
Australia Therapeutic Goods Administration 1-2-21 Drug Repurposing of Prescription Medicines Labeling Visit Page
Australia Therapeutic Goods Administration 1-2-21 Drug Fees and charges proposal 2021-22 Registration Visit Page
Europe European Medicines Agency 1-2-21 Drug Nitrosamine impurity check extends to Rifampicin Labeling Visit Page
USA Food and Drug Administration 1-2-21 Vaccine COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Clinical Visit Page
USA Food and Drug Administration 1-2-21 Medical Device Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests Clinical Visit Page
Europe European Commission 1-2-21 Medical Device "Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional" Registration Visit Page
USA Food and Drug Administration 1-2-21 Drug 2020 CDER Annual Report General Visit Page
Australia Therapeutic Goods Administration 1-2-21 Drug Safety advisory - enhanced warnings relating Safety advisory - enhanced warnings relating Labeling Visit Page
USA Food and Drug Administration 29-1-21 Drug Manufacturing, Supply Chain, and Drug Inspections - COVID-19 CMC Visit Page
Australia Therapeutic Goods Administration 29-1-21 Medical Device Emergency COVID-19 exemptions end for ventilators and personal protective equipment General Visit Page
The Philippines Philippines FDA 13-1-21 Drug Revised guidelines on the cold chain Revised guidelines on the cold chain Revised guidelines on the cold chain and establishments Labeling Visit Page
Malaysia National Pharmaceutical Regulatory Agency 1-1-21 Medicine Drug Registration Guidance Document (DRGD) Registration Visit Page
Europe European Medicines Agency 1-1-21 Drug-Device Combination "Pilot phase for CHMP early contact with patient / consumer organisations" Clinical Visit Page

Country/Region

Australia

Date of Publishing

17-8-22

Product Type

Medical Device

Topic

Regulation of software based medical devices

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-8-22

Product Type

Medical Device

Topic

Sterilization for Medical Devices

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

27-7-22

Product Type

Drug

Topic

EMA response to the monkeypox public health emergency

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

25-7-22

Product Type

Drug

Topic

Proposed Rule on Revising the National Drug Code Format

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

25-7-22

Product Type

Medical Device

Topic

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

22-7-22

Product Type

Drug

Topic

FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

21-7-22

Product Type

Drug

Topic

ICH Guideline M12 on drug interaction studies (draft guidance)

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

20-7-22

Product Type

Drug

Topic

Nitrosamine impurities in medicines - Information for sponsors and manufacturers

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

18-7-22

Product Type

Medical Device

Topic

Tracking Your Premarket Submission’s Progress (Progress Tracker)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

15-7-22

Product Type

Drug

Topic

Towards better prevention of medicine shortages in the EU

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

14-7-22

Product Type

Biologics

Topic

Questions and answers on the proposal for a new legislation on blood, tissues, and cells

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

13-7-22

Product Type

Medical Device

Topic

MDCG 2022-12 - Harmonized administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

12-7-22

Product Type

Drug

Topic

Import, Advertising and Supply Compliance Priorities 2022-23

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

12-7-22

Product Type

Drug

Topic

Information about the raw data proof-of-concept pilot for industry

Domain

Clinical

URL

Country/Region

India

Date of Publishing

11-7-22

Product Type

Medical Device

Topic

Clarification on medical devices quality certificates

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

11-7-22

Product Type

Drug

Topic

Concept paper on the revision of the guideline on the chemistry of active substances

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

11-7-22

Product Type

Vaccine

Topic

ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

11-7-22

Product Type

Drug

Topic

Proposed warning and advisory statement for ocular decongestants used for eye redness and/or minor eye irritation: Do not use in children under 12 years of age

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

8-7-22

Product Type

Drug

Topic

Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimize risk of meningioma

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

8-7-22

Product Type

Drug

Topic

List of the “main therapeutic groups” (MTGs) in crisis preparedness

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

7-7-22

Product Type

Medical Device

Topic

Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) (draft guidance)

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

7-7-22

Product Type

Medical Device

Topic

Guidance on post-market surveillance of In-Vitro Diagnostic Medical Device (draft guidance)

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

7-7-22

Product Type

Medical Device

Topic

Guidance on Stability Studies of In-vitro Diagnostic Medical Device (draft guidance)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

4-7-22

Product Type

Medical Device

Topic

Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

4-7-22

Product Type

Biologics

Topic

Report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' - TGA response

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-7-22

Product Type

Drug

Topic

Quality of medicines questions and answers: Part 2

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Identifying Trading Partners Under the Drug Supply Chain Security Act (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Changes to Disposable Manufacturing Materials: Questions and Answers

Domain

Quality

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format

Domain

Labeling

URL

Country/Region

The Philippines

Date of Publishing

1-7-22

Product Type

Medical Device

Topic

Amendment to FDA Circular NO. 2017-013, entitled, “guidelines on the issuance of clearance for customs release (CFCR) of radiation devices

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Evaluation of Therapeutic Equivalence (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding” (draft guidance)

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug and Biological Product

Topic

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

1-7-22

Product Type

Medical Device

Topic

First Spanish group designated under MDR

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Conducting Remote Regulatory Assessments Questions and Answers (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Orange Book Questions and Answers

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug and Biological Product

Topic

Real-Time Oncology Review (RTOR) (draft guidance)

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

1-7-22

Product Type

Drug

Topic

Malaysian variation guideline for pharmaceutical products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

30-6-22

Product Type

Medical Device

Topic

General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

28-6-22

Product Type

Drug

Topic

Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability 

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

27-6-22

Product Type

Drug

Topic

Outcome of the consultation on the proposed warning and advisory statements relating to harm of long-term use and overuse of stimulant laxatives

Domain

Labeling

URL

Country/Region

Australia

Date of Publishing

27-6-22

Product Type

Medical Device

Topic

Clinical evidence guidelines for medical devices

Domain

Clinical

URL

Country/Region

UK

Date of Publishing

27-6-22

Product Type

Medical Device

Topic

UK to strengthen regulation of medical devices to protect patients

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-6-22

Product Type

Drug

Topic

Nonprescription Drug Product with an Additional Condition for Nonprescription Use

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

24-6-22

Product Type

Drug

Topic

Considerations for the Development of Oligonucleotide Therapeutics (draft guidance)

Domain

Clinical

URL

Country/Region

Malaysia

Date of Publishing

24-6-22

Product Type

Medical Device

Topic

Medical device guidance document licensing for establishment

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

23-6-22

Product Type

Drug

Topic

Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price (MRP)

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

23-6-22

Product Type

Drug

Topic

Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

23-6-22

Product Type

Drug

Topic

Assessing the Effects of Food on Drugs in Investigational New Drugs and New Drug Applications—Clinical Pharmacology Considerations

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

23-6-22

Product Type

Drug and Biological Product

Topic

Considerations for Rescinding Breakthrough Therapy Designation

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

21-6-22

Product Type

Medical Device

Topic

Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

20-6-22

Product Type

Medical Device

Topic

Tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

20-6-22

Product Type

Medical Device

Topic

Fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

17-6-22

Product Type

Medical Device

Topic

Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

16-6-22

Product Type

Biologics

Topic

Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (draft guidance)

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

16-6-22

Product Type

Drug and Biological Product

Topic

Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 “Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

16-6-22

Product Type

Medical Device

Topic

Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

15-6-22

Product Type

Vaccine

Topic

Start of rolling review for adapted Comirnaty COVID-19 vaccine

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

15-6-22

Product Type

Drug

Topic

Q9(R1) Quality Risk Management; International Council for Harmonization (draft guidance)

Domain

Quality

URL

Country/Region

Ireland

Date of Publishing

15-6-22

Product Type

Medical Device

Topic

Guide to Performance Studies Conducted in Ireland

Domain

Clinical

URL

Country/Region

India

Date of Publishing

14-6-22

Product Type

Drug

Topic

Draft proposal to include bar codes or QR codes for identified medicinal products

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

14-6-22

Product Type

Drug

Topic

Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (Draft Guidance)

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

13-6-22

Product Type

Medical Device

Topic

MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

10-6-22

Product Type

Drug

Topic

Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

8-6-22

Product Type

Medical Device

Topic

Guideline for re-registration of registered medical device

Domain

Regulatory

URL

Country/Region

Italy

Date of Publishing

7-6-22

Product Type

Drug

Topic

Launch of new Pharmacovigilance Network

Domain

Pharmacovigilance

URL

Country/Region

USA

Date of Publishing

7-6-22

Product Type

Medical Device

Topic

Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices--Questions and Answers (Revised); Withdrawal of Guidance

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

6-6-22

Product Type

Drug and Biological Product

Topic

Assessment of the Appropriate Net Container Content for Injectable Drug and Biological Products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

6-6-22

Product Type

Medical Device

Topic

Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-6-22

Product Type

Medical Device

Topic

EFPIA statement on the concerning impact of the In Vitro Diagnostic Regulation

Domain

Clinical

URL

Country/Region

France

Date of Publishing

2-6-22

Product Type

Drug

Topic

New edition of good pharmacovigilance practices

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

2-6-22

Product Type

Drug

Topic

Questions and answers - Complex clinical trials

Domain

Clinical

URL

Country/Region

Switzerland

Date of Publishing

1-6-22

Product Type

Drug

Topic

Applications for clinical trials for medicinal products

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

1-6-22

Product Type

Medical Device

Topic

Draft standardization request amending Implementing Decision C (2021) 2406 of 14.4.2021

Domain

Regulatory

URL

Country/Region

Japan

Date of Publishing

1-6-22

Product Type

Drug-Device Combination

Topic

Pharmaceuticals and Medical Devices Safety Information

Domain

Safety

URL

Country/Region

USA

Date of Publishing

1-6-22

Product Type

Medical Device

Topic

Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-6-22

Product Type

Drug and Biological Product

Topic

Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment

Domain

Clinical

URL

Country/Region

The Philippines

Date of Publishing

1-6-22

Product Type

Drug

Topic

Implementing Guidelines on the Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

1-6-22

Product Type

Medical Device

Topic

Uniform Recall Procedure for Therapeutic Goods (URPTG)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-6-22

Product Type

Drug and Biological Product

Topic

Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment

Domain

Clinical

URL

Country/Region

Ireland

Date of Publishing

30-5-22

Product Type

Drug

Topic

Stakeholder Consultation on Registration of Processes exempted under Article 61(5) and applicable requirements under Article 61(6) of the CTR

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

27-5-22

Product Type

Medical Device

Topic

Seasonal Influenza Rapid Antigen Self-tests and Combination tests Clinical performance requirements and risk mitigation strategies

Domain

Clinical

URL

Country/Region

Switzerland

Date of Publishing

26-5-22

Product Type

Medical Device

Topic

Performance studies with IVD

Domain

Clinical

URL

Country/Region

Switzerland

Date of Publishing

26-5-22

Product Type

Medical Device

Topic

New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

20-5-22

Product Type

Drug

Topic

Product-Specific Guidance’s; Draft and Revised Draft Guidance’s for Industry; Availability

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

19-5-22

Product Type

Drug

Topic

Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address pediatric-specific clinical data requirements

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

19-5-22

Product Type

Drug

Topic

Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

18-5-22

Product Type

Drug

Topic

Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodies

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

18-5-22

Product Type

Medical Device

Topic

Suspension and cancellation of medical device licenses

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

16-5-22

Product Type

Drug

Topic

PIC/S work plan for 2022

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

11-5-22

Product Type

Medical Device

Topic

Amending Implementing Decision (EU) 2021/1182 as regards harmonized standards for quality management systems, sterilization, and application of risk management to medical devices

Domain

Quality

URL

Country/Region

Europe

Date of Publishing

11-5-22

Product Type

Drug

Topic

Public Consultation Concerning the Physical Attendance and The Location of Personal Residency of The Qualified Person

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

10-5-22

Product Type

Drug

Topic

Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

9-5-22

Product Type

Drug

Topic

Independent expert report on the risks of intentional self-poisoning with paracetamol

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

6-5-22

Product Type

Medical Device

Topic

Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program (draft guidance)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

5-5-22

Product Type

Drug

Topic

Good Clinical Practice (GCP) inspection procedures – annexures updated

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

4-5-22

Product Type

Drug

Topic

FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

4-5-22

Product Type

Medical Device

Topic

MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

Domain

Regulatory

URL

Country/Region

Denmark

Date of Publishing

3-5-22

Product Type

Drug

Topic

New executive order raises fees in the area of the Danish Medicines Agency

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Biologics

Topic

Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy (draft guidance)

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

2-5-22

Product Type

Drug

Topic

Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

2-5-22

Product Type

Drug

Topic

Questions and answers on the packaging and labelling requirements for medicinal products intended to prevent or combat COVID-19

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Biologics

Topic

Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies Guidance for Industry (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Risk Management Plans to Mitigate the Potential for Drug Shortages (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Biologics

Topic

Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Benefit-Risk Considerations for Product Quality Assessments (draft guidance)

Domain

CMC

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

2-5-22

Product Type

Medical Device

Topic

MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

2-5-22

Product Type

Drug

Topic

Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

2-5-22

Product Type

Medical Device

Topic

Good Storage and Distribution Practices for Medical Devices (draft guidance)

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

2-5-22

Product Type

Drug

Topic

Review of Fees payable under the Medicines Act 1981

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Importation of Prescription Drugs Final Rule Questions and Answers

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

29-4-22

Product Type

Drug

Topic

Proposed amendments to the Poisons Standard – ACCS, ACMS and joint ACCS/ACMS meetings

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

29-4-22

Product Type

Drug

Topic

Crohn’s Disease: Developing Drugs for Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

29-4-22

Product Type

Drug

Topic

Ulcerative Colitis: Developing Drugs for Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

India

Date of Publishing

28-4-22

Product Type

Drug

Topic

Procedure for regularization of FDCs

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

1-4-22

Product Type

Medical Device

Topic

Guidance on the rules of classification for general medical devices

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

31-3-22

Product Type

Drug

Topic

Considerations with respect to future MIDD related guidelines - output from ich model-informed drug development (MIDD)

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

3-2-22

Product Type

Vaccine

Topic

Amendment to FDA Circular No. 2020-029 entitled “Guidance on Applications for the Conduct of COVID-19 Clinical Trials

Domain

Clinical

URL

Country/Region

New Zealand

Date of Publishing

15-4-21

Product Type

Drug

Topic

Outcome of the consultation on the proposed changes to paracetamol warning and advisory statements

Domain

Labeling

URL

Country/Region

Switzerland

Date of Publishing

1-4-21

Product Type

Medical Device

Topic

New requirements and changes to authorisation practice as of May 2021

Domain

Registration

URL

Country/Region

USA

Date of Publishing

25-3-21

Product Type

Drug

Topic

Upcoming Product-Specific Guidances for Complex Generic Drug Product Development

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

24-3-21

Product Type

Vaccine

Topic

New procedure to facilitate and speed up approval of adapted vaccines against Covid-19 variants

Domain

Registration

URL

Country/Region

The Philippines

Date of Publishing

23-3-21

Product Type

Vaccine

Topic

Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection

Domain

Registration

URL

Country/Region

UK

Date of Publishing

23-3-21

Product Type

Drug-Device Combination

Topic

MHRA pilots patient involvement in new applications

Domain

Registration

URL

Country/Region

UK

Date of Publishing

19-3-21

Product Type

Drug-Device Combination

Topic

Guidance for industry on MHRA's expectations for return to UK on-site inspections

Domain

General

URL

Country/Region

USA

Date of Publishing

17-3-21

Product Type

Topic

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premark Review Process

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

17-3-21

Product Type

Drug

Topic

SWP response to CMDh questions on chlorobutanol

Domain

General

URL

Country/Region

Europe

Date of Publishing

17-3-21

Product Type

Drug

Topic

Rapid implementation of the revised sartan monographs on 1 April 2021

Domain

Registration

URL

Country/Region

USA

Date of Publishing

16-3-21

Product Type

Medical Device

Topic

Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

15-3-21

Product Type

Vaccine

Topic

EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update

Domain

Safety

URL

Country/Region

India

Date of Publishing

12-3-21

Product Type

Medical Device

Topic

Change in medical device pricing

Domain

General

URL

Country/Region

Canada

Date of Publishing

12-3-21

Product Type

Drug

Topic

"Electronic media in prescription drug labelling"

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

12-3-21

Product Type

Vaccine

Topic

Labelling flexibilities for COVID-19 therapeutics

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

11-3-21

Product Type

Drug

Topic

How CEP holders can avoid the rejection of notifications

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

10-3-21

Product Type

Vaccine

Topic

"Guidance on state of the art of COVID-19 rapid antibody tests"

Domain

General

URL

Country/Region

Australia

Date of Publishing

10-3-21

Product Type

Vaccine

Topic

COVID-19 vaccines - safety and effectiveness in older adults

Domain

Safety

URL

Country/Region

India

Date of Publishing

10-3-21

Product Type

Vaccine

Topic

Recommendations of the SEC meeting to examine COVID-19 related proposal under accelerated approval process

Domain

Registration

URL

Country/Region

Ireland

Date of Publishing

9-3-21

Product Type

Drug

Topic

Good Distribution Practice of Medicinal Products for Human Use

Domain

General

URL

Country/Region

UK

Date of Publishing

9-3-21

Product Type

Drug

Topic

Importing medicines into Northern Ireland before 31 December 2021

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

9-3-21

Product Type

Medical Device

Topic

IMDRF consultation: Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

Domain

Registration

URL

Country/Region

Ireland

Date of Publishing

9-3-21

Product Type

Drug-Device Combination

Topic

"Guide to New Applications and Variations to Wholesale Distribution Authorisations"

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

5-3-21

Product Type

Drug

Topic

Handling of duplicate marketing authorisation applications of pharmaceutical products under Article 82(1) of Regulation (EC) No 726/2004

Domain

Registration

URL

Country/Region

USA

Date of Publishing

4-3-21

Product Type

Vaccine

Topic

COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

4-3-21

Product Type

Vaccine

Topic

Guidance on strain changes in authorised COVID-19 vaccines

Domain

General

URL

Country/Region

Europe

Date of Publishing

3-3-21

Product Type

Drug

Topic

"Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices"

Domain

General

URL

Country/Region

Europe

Date of Publishing

3-3-21

Product Type

Drug

Topic

EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)

Domain

General

URL

Country/Region

USA

Date of Publishing

3-3-21

Product Type

Topic

Data Modernization Action Plan

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-3-21

Product Type

Drug

Topic

Revision of CEPs referring to one of the "sartan” monographs following their rapid implementation

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

1-3-21

Product Type

Drug

Topic

Guidance Notes Updated API information for product registration

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

26-2-21

Product Type

Medical Device

Topic

Consultation: Proposed regulatory options for medical devices containing nanomaterials (for comments)

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

26-2-21

Product Type

Drug

Topic

First Innovation Passport awarded to help support development and access to cutting-edge medicines

Domain

Registration

URL

Country/Region

Australia

Date of Publishing

25-2-21

Product Type

Medical Device

Topic

Regulatory changes for software based medical devices

Domain

Registration

URL

Country/Region

Australia

Date of Publishing

24-2-21

Product Type

Drug-Device Combination

Topic

The TGA's risk management approach

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

23-2-21

Product Type

Vaccine

Topic

"Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2"

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

Domain

General

URL

Country/Region

USA

Date of Publishing

19-2-21

Product Type

Medical Device

Topic

Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

Domain

Safety

URL

Country/Region

Malaysia

Date of Publishing

18-2-21

Product Type

Drug-Device Combination

Topic

Guidance Document Foreign GMP Inspection

Domain

General

URL

Country/Region

UK

Date of Publishing

17-2-21

Product Type

Drug-Device Combination

Topic

How investigators and sponsors should manage clinical trials during COVID-19

Domain

General

URL

Country/Region

USA

Date of Publishing

16-2-21

Product Type

Medical Device

Topic

"Medical Device User Fees; Stakeholder Meetings on Medical Device User Fee Amendments of Fiscal Years 2023 to 2027 Reauthorization; Request for Notification of Stakeholder Intention to Participate"

Domain

General

URL

Country/Region

Europe

Date of Publishing

15-2-21

Product Type

Medical Device

Topic

Management of Legacy Devices MDR EUDAMED

Domain

General

URL

Country/Region

India

Date of Publishing

12-2-21

Product Type

Drug

Topic

Application for retail price fixation of new drugs through email only

Domain

General

URL

Country/Region

Europe

Date of Publishing

11-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

Denmark

Date of Publishing

10-2-21

Product Type

Vaccine

Topic

Danish Medicines Agency expands capacity for safety monitoring of Covid-19 vaccines

Domain

Safety

URL

Country/Region

UK

Date of Publishing

9-2-21

Product Type

Drug

Topic

Access New Active Substance (NAS) Work Sharing Initiative

Domain

General

URL

Country/Region

USA

Date of Publishing

4-2-21

Product Type

Vaccine

Topic

FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

4-2-21

Product Type

Drug

Topic

Guidance on the management of clinical trials during the Covid-19 (coronavirus) pandemic

Domain

Clinical

URL

Country/Region

International

Date of Publishing

3-2-21

Product Type

Drug

Topic

WHO announces updated critical concentrations for susceptibility testing to rifampicin

Domain

General

URL

Country/Region

Europe

Date of Publishing

3-2-21

Product Type

Drug

Topic

"Questions and Answers on the Pilot Project 'OPEN' - Opening our Procedures at EMA to Non-EU authorities"

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

3-2-21

Product Type

Drug

Topic

Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with revision 3 of Module XVI on risk minimization measures and its Addendum II on methods for their effectiveness evaluation for public consultation

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

2-2-21

Product Type

Drug

Topic

Draft toolbox guidance on scientific elements and 5 regulatory tools to support quality data packages for 6 PRIME marketing authorization applications

Domain

Registration

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Vaccine

Topic

Guidance for Industry - Development of Monoclonal Antibody Products Targeting SARSCoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Vaccine

Topic

COVID-19 vaccine safety monitoring plan

Domain

Safety

URL

Country/Region

UK

Date of Publishing

1-2-21

Product Type

Drug

Topic

Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)

Domain

Safety

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Drug

Topic

Repurposing of Prescription Medicines

Domain

Labeling

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Drug

Topic

Fees and charges proposal 2021-22

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

1-2-21

Product Type

Drug

Topic

Nitrosamine impurity check extends to Rifampicin

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Vaccine

Topic

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Medical Device

Topic

Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

1-2-21

Product Type

Medical Device

Topic

"Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional"

Domain

Registration

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Drug

Topic

2020 CDER Annual Report

Domain

General

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Drug

Topic

Safety advisory - enhanced warnings relating Safety advisory - enhanced warnings relating

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

29-1-21

Product Type

Drug

Topic

Manufacturing, Supply Chain, and Drug Inspections - COVID-19

Domain

CMC

URL

Country/Region

Australia

Date of Publishing

29-1-21

Product Type

Medical Device

Topic

Emergency COVID-19 exemptions end for ventilators and personal protective equipment

Domain

General

URL

Country/Region

The Philippines

Date of Publishing

13-1-21

Product Type

Drug

Topic

Revised guidelines on the cold chain Revised guidelines on the cold chain Revised guidelines on the cold chain and establishments

Domain

Labeling

URL

Country/Region

Malaysia

Date of Publishing

1-1-21

Product Type

Medicine

Topic

Drug Registration Guidance Document (DRGD)

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

1-1-21

Product Type

Drug-Device Combination

Topic

"Pilot phase for CHMP early contact with patient / consumer organisations"

Domain

Clinical

URL

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