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
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Drug Administration	27-10-22	Drug	Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials (draft guidance)	Clinical	Visit Page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and Drug Administration	25-10-22	Drug	In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance)	Regulatory	Visit Page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Food and Drug Administration	21-10-22	Drug	In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance)	Regulatory	Visit Page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21-10-22	Drug	Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (draft guidance)	Regulatory	Visit Page
USA	Food and Drug Administration	21-10-22	Drug	Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (draft guidance)	Regulatory	Visit Page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