
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.

Country/Region | Health Authority | Date of Publishing | Product Type | Topic | Domain | URL |
---|---|---|---|---|---|---|
USA | Food and Drug Administration | 17-11-22 | Drug | Upcoming Product-Specific Guidances for Generic Drug Product Development | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 15-11-22 | Medical Device | Post-market review of ventilators, CPAP and BiPAP devices | Pharmacovigilance | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 8-11-22 | Drug | Submission of Suspected Unexpected Serious Adverse Reactions reports using ICSR submissions or MHRA gateway | Safety | Visit Page |
USA | Food and Drug Administration | 27-10-22 | Drug | Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials (draft guidance) | Clinical | Visit Page |
USA | Food and Drug Administration | 26-10-22 | Drug | Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 25-10-22 | Medical Device | Implementation of the Future Regulations | Regulatory | Visit Page |
USA | Food and Drug Administration | 25-10-22 | Drug | In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 25-10-22 | Drug | Human Gene Therapy for Neurodegenerative Diseases | Clinical | Visit Page |
Europe | European Medicines Agency | 24-10-22 | Drug | Information about the raw data proof-of-concept pilot for industry | Clinical | Visit Page |
USA | Food and Drug Administration | 21-10-22 | Drug | In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 21-10-22 | Drug | Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 21-10-22 | Drug | Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (draft guidance) | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 21-10-22 | Drug | GMP Clearance: Temporary changes to target processing times | Regulatory | Visit Page |
USA | Food and Drug Administration | 21-10-22 | Medical Device | Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 20-10-22 | Drug | Multiple Endpoints in Clinical Trials | Clinical | Visit Page |
USA | Food and Drug Administration | 18-10-22 | Drug | ANDA Submissions – Prior Approval Supplements Under GDUFA | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 17-10-22 | Medical Device | Software and AI as a Medical Device Change Programme - Roadmap | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 17-10-22 | Drug | Pharmacovigilance Inspection Program Risk Assessment Survey | Pharmacovigilance | Visit Page |
USA | Food and Drug Administration | 17-10-22 | Drug | Tissue Agnostic Drug Development in Oncology | Clinical | Visit Page |
USA | Food and Drug Administration | 17-10-22 | Drug | Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials | Clinical | Visit Page |
USA | Food and Drug Administration | 17-10-22 | Drug | Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment | Clinical | Visit Page |
USA | Food and Drug Administration | 17-10-22 | Drug | Complex Generics News | Regulatory | Visit Page |
Europe | European Medicines Agency | 14-10-22 | Drug | European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance | Clinical | Visit Page |
USA | Food and Drug Administration | 14-10-22 | Drug | Comparability Protocols for Post approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA | CMC | Visit Page |
USA | Food and Drug Administration | 12-10-22 | Drug | Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 11-10-22 | Medical Device | Classification of medical device pertaining to oncology under the provisions of medical devices rules, 2017 | Regulatory | Visit Page |
Denmark | Danish Medicines Agency | 11-10-22 | Drug | Current Danish QRD template to be used in connection with the granting of marketing authorizations | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 7-10-22 | Drug | GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 7-10-22 | Drug | Boundary and combination products guidance - medicines, medical devices, and biologicals | Regulatory | Visit Page |
USA | Food and Drug Administration | 7-10-22 | Medical Device | Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order | Clinical | Visit Page |
USA | Food and Drug Administration | 6-10-22 | Medical Device | Post market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-10-22 | Drug | Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-10-22 | Drug | Information Requests and Discipline Review Letters Under GDUFA | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-10-22 | Drug | Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-10-22 | Drug | Competitive Generic Therapies | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Drug | Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA (Draft guidance) | CMC | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Medical Device | FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Medical Device | FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Medical Device | FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Drug | Facility Readiness: Goal Date Decisions Under GDUFA (Draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Drug | Split Real Time Application Review (STAR) | Regulatory | Visit Page |
The Philippines | Philippines FDA | 3-10-22 | Drug | Amendment to Administrative Order No. 2020-0017 entitled, “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003” (Draft guidance) | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 3-10-22 | Drug | National list of Essential Medicines 2022 | Regulatory | Visit Page |
Japan | Pharmaceuticals and Medical Devices Agency | 3-10-22 | Drug | PDG Welcomes Indian Pharmacopoeia Commission to Pilot for Global Expansion | Regulatory | Visit Page |
Ireland | Health Products Regulatory Authority | 1-10-22 | Drug | Public Consultation on Annual Review and Proposal for Fees – Financial Year 2023 | Regulatory | Visit Page |
Europe | European Medicines Agency | 30-9-22 | Drug | Data Quality Framework for EU medicines regulation | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 30-9-22 | Drug | European Commission Decision Reliance Procedure (EC DRP) extension | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 30-9-22 | Medical Device | Regulation of all Class A & B Medical Devices under Licensing regime | Regulatory | Visit Page |
Global | INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE | 29-9-22 | Drug | Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin Q5A(R2) | Safety | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 29-9-22 | Medical Device | MHRA appoints first new UK Approved Body to certify medical devices since Brexit | Regulatory | Visit Page |
Europe | European Medicines Agency | 29-9-22 | Drug | EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 28-9-22 | Drug | User experience survey - Database of Adverse Event Notifications (DAEN) – medicines beta version | Safety | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Medical Device | Display Devices for Diagnostic Radiology | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Medical Device | Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Medical Device | Clinical Decision Support Software | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Medical Device | Policy for Device Software Functions and Mobile Medical Applications | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Drug | Protection of Human Subjects and Institutional Review Boards | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Vaccine | Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised); Immediately in Effect Guidance for Commercial Manufacturers and Food and Drug Administration Staff; Availability | Regulatory | Visit Page |
Global | INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE | 27-9-22 | Drug | Clinical electronic structured harmonized protocol (CESHARP) M11 | Clinical | Visit Page |
Global | INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE | 27-9-22 | Drug | A selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials E19 | Safety | Visit Page |
The Philippines | Philippines FDA | 27-9-22 | Medical Device | Abridged Processing of Application for Registration of Medical Devices Approved by the National Regulatory Authority of Any ASEAN Member Country | Regulatory | Visit Page |
USA | Food and Drug Administration | 23-9-22 | Drug | New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials | Clinical | Visit Page |
USA | Food and Drug Administration | 22-9-22 | Medical Device | Electronic Submission Template for Medical Device 510(k) Submissions | Regulatory | Visit Page |
Europe | European Medicines Agency | 19-9-22 | Biologics | Biosimilar medicines can be interchanged | Regulatory | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 14-9-22 | Drug | Potential nitrosamine contamination – harmonised implementation (update) | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 14-9-22 | Drug | Independent review of paracetamol overdose | Safety | Visit Page |
Europe | European Commission | 14-9-22 | Medical Device | MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR | Regulatory | Visit Page |
Europe | European Commission | 14-9-22 | Medical Device | MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies | Regulatory | Visit Page |
USA | Food and Drug Administration | 14-9-22 | Drug | Annual Summary Reporting Requirements Under the Right to Try Act | Regulatory | Visit Page |
USA | Food and Drug Administration | 14-9-22 | Medical Device | SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests | Regulatory | Visit Page |
Japan | Pharmaceuticals and Medical Devices Agency | 13-9-22 | Drug | Labeling of Codes on Containers to Identify Regenerative Medical Products, etc | Labeling | Visit Page |
Japan | Pharmaceuticals and Medical Devices Agency | 13-9-22 | Drug | Labeling of Codes on Containers to Identify Prescription Drugs | Labeling | Visit Page |
USA | Food and Drug Administration | 13-9-22 | Drug | Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List Under the 21st Century Cures Act | Regulatory | Visit Page |
USA | Food and Drug Administration | 13-9-22 | Medical Device | Computer Software Assurance for Production and Quality System Software (draft guidance) | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 9-9-22 | Medical Device | Classification of non-sterile, non-powered, hand-held, or hand-manipulated surgical instruments for general use intended to be used in surgical procedures | Regulatory | Visit Page |
Europe | European Commission | 8-9-22 | Medical Device | Medical devices - reclassification of products without an intended medical purpose | Regulatory | Visit Page |
Europe | European Commission | 7-9-22 | Medical Device | Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices | Regulatory | Visit Page |
USA | Food and Drug Administration | 7-9-22 | Drug | Policy for Monkeypox Tests to Address the Public Health Emergency, Guidance for Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff | Regulatory | Visit Page |
Europe | European Medicines Agency | 2-9-22 | Drug | Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022 | Pharmacovigilance | Visit Page |
Europe | European Medicines Agency | 1-9-22 | Drug | Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-9-22 | Drug | Providing Over-the-Counter Monograph Submissions in Electronic Format (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-9-22 | Drug | Ethical Considerations for Clinical Investigations of Medical Products Involving Children | Clinical | Visit Page |
Malaysia | Medical Device Authority | 1-9-22 | Medical Device | Guideline for re-registration of registered medical device | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-9-22 | Drug | Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-9-22 | Drug | Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over the Counter and Prescription Drug Products | Labeling | Visit Page |
USA | Food and Drug Administration | 1-9-22 | Drug | Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products (draft guidance) | Labeling | Visit Page |
USA | Food and Drug Administration | 1-9-22 | Drug | General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products Guidance for Industry | Pharmacovigilance | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 1-9-22 | Drug | Canada - United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 1-9-22 | Drug | Consultation: Proposed amendments to the Poisons Standard – ACCS, ACMS and joint ACCS/ACMS meetings, November 2022 | Safety | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 31-8-22 | Drug | Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 30-8-22 | Medical Device | Licensing for establishment | Regulatory | Visit Page |
Europe | European Commission | 26-8-22 | Medical Device | MDCG 2022-14 - Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs | Regulatory | Visit Page |
Europe | European Commission | 25-8-22 | Medical Device | evision - Manufacture of Sterile Medicinal Products | Regulatory | Visit Page |
Europe | European Directorate for the Quality of Medicines and Healthcare | 23-8-22 | Drug | Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products | Regulatory | Visit Page |
The Philippines | Philippines FDA | 23-8-22 | Drug | Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines (draft for comments) | Clinical | Visit Page |
Australia | Therapeutic Goods Administration | 17-8-22 | Medical Device | Exemption for Certain Clinical Decision Support Software | Clinical | Visit Page |
USA | Food and Drug Administration | 17-8-22 | Medical Device | Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices | Regulatory | Visit Page |
USA | Food and Drug Administration | 17-8-22 | Medical Device | Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions (draft guidance) | Labeling | Visit Page |
USA | Food and Drug Administration | 17-8-22 | Medical Device | Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 17-8-22 | Medical Device | Regulation of software based medical devices | Regulatory | Visit Page |
Singapore | Health Sciences Authority | 12-8-22 | Medical Device | Potential increase of mortality and amputation risk associated with paclitaxel-coated devices | Safety | Visit Page |
Europe | European Commission | 10-8-22 | Medical Device | MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies | Regulatory | Visit Page |
USA | Food and Drug Administration | 10-8-22 | Medical Device | Ethylene Oxide Risk from Commercial Sterilizers | Regulatory | Visit Page |
International | The International Council for Harmonisation | 4-8-22 | Drug | Testing for carcinogenicity of pharmaceuticals | Safety | Visit Page |
Europe | European Directorate for the Quality of Medicines and Healthcare | 4-8-22 | Drug | itrosamines – Deadline extension for all CEP holders to complete step 3 Revision to the CEP (now 1 October 2023) | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 4-8-22 | Medical Device | Classification of medical devices pertaining to rehabilitation under the provisions of Medical Devices rule | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-8-22 | Medical Device | Sterilization for Medical Devices | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 1-8-22 | Drug | Regulatory options to potentially allow references to the TGA in therapeutic goods advertising | Labeling | Visit Page |
Malaysia | Medical Device Authority | 1-8-22 | Medical Device | Harmonized classification of medical devices in ASEAN | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-8-22 | Drug | Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry (draft guidance) | Regulatory | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 1-8-22 | Drug | Changes to Guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4 | Regulatory | Visit Page |
Europe | European Medicines Agency | 1-8-22 | Drug | Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-8-22 | Drug | Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies (draft guidance) | Publishing | Visit Page |
India | Central Drugs Standard Control Organisation | 29-7-22 | Medical Device | Price control on medical devices | Regulatory | Visit Page |
Europe | European Medicines Agency | 28-7-22 | Drug | Key performance indicators (KPIs) to monitor the European clinical trials environment | Clinical | Visit Page |
Europe | European Medicines Agency | 28-7-22 | Drug | Big Data Workplan 2022-2025 | Regulatory | Visit Page |
New Zealand | New Zealand Medicines and Medical Devices Safety | 27-7-22 | Drug | Outcome of the consultation on the proposed warning and advisory statements relating to the harm of opioid abuse | Labeling | 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 | 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 | 25-7-22 | Drug | Proposed Rule on Revising the National Drug Code Format | Labeling | 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 |
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 |
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 | 11-7-22 | Vaccine | ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines | Regulatory | 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 | 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 | Guidance on Stability Studies of In-vitro Diagnostic Medical Device (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 | Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) (draft guidance) | 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 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 |
Malaysia | National Pharmaceutical Regulatory Agency | 1-7-22 | Drug | Active Pharmaceutical Ingredient (API) Information (PART II S) for product registration application via quest system | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug | Changes to Disposable Manufacturing Materials: Questions and Answers | Regulatory | 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 and Biological Product | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products | Clinical | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug and Biological Product | Real-Time Oncology Review (RTOR) (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 | Conducting Remote Regulatory Assessments Questions and Answers (draft guidance) | Regulatory | 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 | 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 | Evaluation of Therapeutic Equivalence (draft guidance) | Regulatory | 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 |
Malaysia | National Pharmaceutical Regulatory Agency | 1-7-22 | Drug | Malaysian variation guideline for pharmaceutical products | Regulatory | 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 |
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 | 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 |
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 |
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 |
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 |
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 | Biologics | Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (draft guidance) | 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 |
Ireland | Health Products Regulatory Authority | 15-6-22 | Medical Device | Guide to Performance Studies Conducted in Ireland | Clinical | 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 |
Europe | European Medicines Agency | 15-6-22 | Vaccine | Start of rolling review for adapted Comirnaty COVID-19 vaccine | Regulatory | 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 |
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 | Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment | Clinical | 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 |
Japan | Pharmaceuticals and Medical Devices Agency | 1-6-22 | Drug-Device Combination | Pharmaceuticals and Medical Devices Safety Information | Safety | 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 |
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 |
Europe | European Commission | 1-6-22 | Medical Device | Draft standardization request amending Implementing Decision C (2021) 2406 of 14.4.2021 | Regulatory | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 1-6-22 | Drug | Applications for clinical trials for medicinal products | 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 |
Japan | Pharmaceuticals and Medical Devices Agency | 25-5-22 | Medical Device | Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products | Regulatory | 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 |
India | Central Drugs Standard Control Organisation | 18-5-22 | Medical Device | Suspension and cancellation of medical device licenses | Regulatory | 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 |
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 |
Australia | Therapeutic Goods Administration | 4-5-22 | Drug | Update to Manufacturing Principles for medicines, APIs & sunscreens | 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 |
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 |
Denmark | Danish Medicines Agency | 3-5-22 | Drug | New executive order raises fees in the area of the Danish Medicines Agency | 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 |
USA | Food and Drug Administration | 2-5-22 | Drug | Importation of Prescription Drugs Final Rule Questions and Answers | 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 | 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 | Biologics | Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy (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 |
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 |
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 |
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 | 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 | Benefit-Risk Considerations for Product Quality Assessments (draft guidance) | CMC | 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 |
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 |
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 |
Japan | Pharmaceuticals and Medical Devices Agency | 18-3-22 | Drug | Questions and Answers (Qs and As) on Risk Management Plan | Quality | 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 |
UK | Medicines and Healthcare products Regulatory Agency | 23-3-21 | Drug-Device Combination | MHRA pilots patient involvement in new applications | 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 | 19-3-21 | Drug-Device Combination | Guidance for industry on MHRA's expectations for return to UK on-site inspections | 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 | 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 |
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 |
Europe | European Medicines Agency | 12-3-21 | Vaccine | Labelling flexibilities for COVID-19 therapeutics | Labeling | Visit Page |
Canada | Health Canada | 12-3-21 | Drug | "Electronic media in prescription drug labelling" | 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 |
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 |
Europe | European Commission | 10-3-21 | Vaccine | "Guidance on state of the art of COVID-19 rapid antibody tests" | 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 |
Ireland | Health Products Regulatory Authority | 9-3-21 | Drug | Good Distribution Practice of Medicinal Products for Human Use | General | 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 |
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 |
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 |
UK | Medicines and Healthcare products Regulatory Agency | 4-3-21 | Vaccine | Guidance on strain changes in authorised COVID-19 vaccines | General | 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 |
USA | Food and Drug Administration | 3-3-21 | Data Modernization Action Plan | Regulatory | Visit Page | |
Europe | European Medicines Agency | 3-3-21 | Drug | EMA issues advice on use of antibody combination (bamlanivimab / etesevimab) | 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 |
Malaysia | National Pharmaceutical Regulatory Agency | 1-3-21 | Drug | Guidance Notes Updated API information for product registration | 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 |
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 | 26-2-21 | Medical Device | Consultation: Proposed regulatory options for medical devices containing nanomaterials (for comments) | Regulatory | 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 |
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 |
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 | 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 Authority | 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 |
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 | 3-2-21 | Drug | "Questions and Answers on the Pilot Project 'OPEN' - Opening our Procedures at EMA to Non-EU authorities" | Registration | 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 | 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 |
Australia | Therapeutic Goods Administration | 1-2-21 | Drug | Safety advisory - enhanced warnings relating Safety advisory - enhanced warnings relating | Labeling | 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 |
Australia | Therapeutic Goods Administration | 1-2-21 | Vaccine | COVID-19 vaccine safety monitoring plan | Safety | 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 |
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 |
USA | Food and Drug Administration | 1-2-21 | Vaccine | COVID-19: Developing Drugs and Biological Products for Treatment or Prevention | 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 | 29-1-21 | Medical Device | Emergency COVID-19 exemptions end for ventilators and personal protective equipment | General | Visit Page |
USA | Food and Drug Administration | 29-1-21 | Drug | Manufacturing, Supply Chain, and Drug Inspections - COVID-19 | CMC | 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 |
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