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	3-4-23	Medical Device	Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (draft guidance	Regulatory	Visit Page
USA	Food and Drug Administration	3-4-23	Drug	Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act	Regulatory	Visit Page
Japan	Pharmaceuticals and Medical Devices Agency	3-4-23	Drug	Ministerial Ordinance on Good Clinical Practice for Drugs	Clinical	Visit Page
USA	Food and Drug Administration	3-4-23	Drug	Mpox: Development of Drugs and Biological Products (draft guidance)	Clinical	Visit Page
USA	Food and Drug Administration	30-3-23	Medical Device	Medical Device Development Tools (MDDT)	Regulatory	Visit Page
USA	Food and Drug Administration	30-3-23	Medical Device	Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act	Regulatory	Visit Page
USA	Food and Drug Administration	29-3-23	Medical Device	Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions (draft guidance)	Regulatory	Visit Page
UK	Medicines and Healthcare products Regulatory Agency	28-3-23	Medical Device	Extension of CE certificates	Regulatory	Visit Page
USA	Food and Drug Administration	28-3-23	Medical Device	General Considerations for Animal Studies Intended to Evaluate Medical Devices	Safety	Visit Page
Switzerland	The Swiss Agency for Therapeutic Products	27-3-23	Medical Device	Findings on manufacturers failing to meet post market surveillance requirements	Regulatory	Visit Page
USA	Food and Drug Administration	27-3-23	Drug	Update on In-Person Face-to-Face ANDA Meetings	Regulatory	Visit Page
USA	Food and Drug Administration	27-3-23	Drug	Clinical trial considerations to support accelerated approval of oncology therapeutics (draft guidance)	Clinical	Visit Page
USA	Food and Drug Administration	27-3-23	Medical Device	Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency	Regulatory	Visit Page
USA	Food and Drug Administration	27-3-23	Medical Device	Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)	Regulatory	Visit Page
Australia	Therapeutic Goods Administration	24-3-23	Drug	TGA’s new powers will help reduce the impact of medicine shortages on patients	Regulatory	Visit Page
Malaysia	Medical Device Authority	23-3-23	Medical Device	Withdrawal of medical device registration (new and re-register) and change of notification application	Regulatory	Visit Page
UK	Medicines and Healthcare products Regulatory Agency	21-3-23	Drug	Consultation outcome - Government response to consultation on legislative proposals for clinical trials	Clinical	Visit Page
UK	Medicines and Healthcare products Regulatory Agency	21-3-23	Drug	MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years	Clinical	Visit Page
Australia	Therapeutic Goods Administration	20-3-23	Drug	GMP Clearance: Additional countries added to MRA pathway	Regulatory	Visit Page
UK	Medicines	20-3-23	Medical Device	Request for an update of the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties	Safety	Visit Page
USA	Food and Drug Administration	20-3-23	Medical Device	Send and Track Medical Device Premarket Submissions Online: CDRH Portal	Regulatory	Visit Page
Malaysia	National Pharmaceutical Regulatory Agency	17-3-23	Drug	Topiramate: Neurodevelopmental disorders in children exposed to topiramate during pregnancy	Regulatory	Visit Page
Argentina	ANMAT	16-3-23	Drug	ANMAT signed a Memorandum of Understanding with the United States Pharmacopoeia	Regulatory	Visit Page
USA	Food and Drug Administration	16-3-23	Drug	Pharmacogenomic Data Submissions (draft guidance)	Regulatory	Visit Page
Malaysia	National Pharmaceutical Regulatory Agency	13-3-23	Drug	Declaration of Worldwide Registration Status for Generic Medicines in QUEST System	Regulatory	Visit Page
USA	Food and Drug Administration	10-3-23	Drug	Evaluation of Gastric pH Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications	Clinical	Visit Page
Europe	European Medicines Agency	9-3-23	Drug	Guideline on computerized systems and electronic data in clinical trials	Regulatory	Visit Page
Malaysia	Medical Device Authority	8-3-23	Medical Device	Classification of rehabilitation, physiotherapy, and speech therapy device	Regulatory	Visit Page
Europe	European Medicines Agency	8-3-23	Medical Device	Amendment of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (MDR)	Regulatory	Visit Page
Europe	European Medicines Agency	8-3-23	Medical Device	Amendment of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (IVDR)	Regulatory	Visit Page
Europe	European Medicines Agency	7-3-23	Medical Device	Council takes action to mitigate risk of medical devices shortage y extending the MDR deadlines	Regulatory	Visit Page
Europe	European Medicines Agency	7-3-23	Drug	Questions and Answers about the raw data proof-of-concept pilot for industry	Clinical	Visit Page
UK	Medicines and Healthcare products Regulatory Agency	7-3-23	Medical Device	https://www.gov.uk/government/news/windsor-framework-unveiled-to-fix-problems-of-the-northern-ireland-protocol	Regulatory	Visit Page
USA	Food and Drug Administration	7-3-23	Drug	Nitrosamine Impurities: Latest USP Tool Further Aids Understanding and Control	Regulatory	Visit Page
The Philippines	Philippines FDA	6-3-23	Drug	Guidelines on Regulatory Reliance on the Conduct of Clinical Trials	Clinical	Visit Page
USA	Food and Drug Administration	4-3-23	Medical Device	Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway	Regulatory	Visit Page
Europe	European Medicines Agency	3-3-23	Drug	European Pharmacopoeia Commission creates new Excipients Strategy Working Party	Regulatory	Visit Page
USA	Food and Drug Administration	2-3-23	Drug	Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for Industry	Regulatory	Visit Page
Switzerland	The Swiss Agency for Therapeutic Products	1-3-23	Drug	New Mobile technologies guidance document for human and veterinary medicinal products	packaging	Visit Page
Europe	European Medicines Agency	1-3-23	Medical Device	Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP)	Clinical	Visit Page
Europe	European Medicines Agency	1-3-23	Medical Device	Extension of the MDR transitional period and removal of the ‘sell off’ periods	Regulatory	Visit Page
USA	Food and Drug Administration	1-3-23	Drug	Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (draft guidance)	Clinical	Visit Page
USA	Food and Drug Administration	1-3-23	Drug	Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act	Regulatory	Visit Page
USA	Food and Drug Administration	1-3-23	Drug	Development of Local Anesthetic Drug Products with Prolonged Duration of Effect	Clinical	Visit Page
USA	Food and Drug Administration	1-3-23	Medical Device	Total Product Life Cycle Advisory Program (TAP)	Regulatory	Visit Page
USA	Food and Drug Administration	1-3-23	Drug	Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments	Regulatory	Visit Page
Malaysia	Medical Device Authority	28-2-23	Medical Device	Notification of custom-made medical device	Regulatory	Visit Page
USA	Food and Drug Administration	28-2-23	Drug	CDER Continues to Advance Rare Disease Drug Development with New Efforts, Including the Accelerating Rare Disease Cures (ARC) Program	Regulatory	Visit Page
UK	Medicines and Healthcare products Regulatory Agency	27-2-23	Drug	Windsor Framework unveiled to fix problems of the Northern Ireland Protocol	Regulatory	Visit Page
New Zealand	New Zealand Medicines and Medical Devices Safety	27-2-23	Drug	Outcome of the consultation on the proposed warning and advisory statements for ocular decongestants for eye redness and/or minor eye irritation	Safety	Visit Page
Malaysia	Medical Device Authority	24-2-23	Medical Device	Malaysia MDA introduces new online payment system	Regulatory	Visit Page
USA	Food and Drug Administration	23-2-23	Medical Device	Examples of Medical Device Misconnections	Regulatory	Visit Page
Europe	European Medicines Agency	22-2-23	Drug	Question and Answer on the submission of applications for the expert panels’ advice to manufacturers	Regulatory	Visit Page
USA	Food and Drug Administration	21-2-23	Drug	Press Statement: 21 February 2023 FDA Philippines Launches Task Force Fleming to Make Safe and Effective Covid-19 Drugs More Accessible to All Filipinos	Regulatory	Visit Page
UK	Medicines and Healthcare products Regulatory Agency	20-2-23	Medical Device	Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU	Regulatory	Visit Page
Europe	European Medicines Agency	16-2-23	Biologics	Adjuvants in vaccines for human use - Scientific guideline	Regulatory	Visit Page
Europe	European Medicines Agency	10-2-23	Drug	Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023	Pharmacovigilance	Visit Page
Europe	European Medicines Agency	9-2-23	Drug	Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR)	Clinical	Visit Page
USA	Food and Drug Administration	9-2-23	Medical Device	Medical Device Material Safety Summaries	Safety	Visit Page
Australia	Therapeutic Goods Administration	8-2-23	Drug	Avoid prescribing pregabalin in pregnancy if possible	Safety	Visit Page
USA	Food and Drug Administration	8-2-23	Drug	Artificial Intelligence/Machine Learning Assisted Image Analysis for Characterizing Biotherapeutics	Regulatory	Visit Page
USA	Food and Drug Administration	7-2-23	Drug	ANDA Assessment Program \| GDUFA III Performance Goals and Program Enhancements	Regulatory	Visit Page
Global	International Medical Device Regulators Forum	7-2-23	Medical Device	IMDRF Terms of Reference	Regulatory	Visit Page
Europe	European Medicines Agency	6-2-23	Drug	Guidance for Stepwise PIP pilot	Clinical	Visit Page
Europe	European Medicines Agency	6-2-23	Drug	EFPIA response to EU Commission proposal for revised EMA Fees regulation	Regulatory	Visit Page
Global	International Medical Device Regulators Forum	3-2-23	Medical Device	Medical Device Regulatory Review Report: Guidance Regarding Information to be Included	Regulatory	Visit Page
Europe	European Medicines Agency	3-2-23	Drug	Public consultation on a multi-stakeholder platform to improve clinical trials in the EU	Clinical	Visit Page
UK	Medicines and Healthcare products Regulatory Agency	3-2-23	Medical Device	Medical technology strategy	Regulatory	Visit Page
Australia	Therapeutic Goods Administration	3-2-23	Drug	Change to classification of psilocybin and MDMA to enable prescribing by authorized psychiatrists.	Regulatory	Visit Page
Australia	Therapeutic Goods Administration	3-2-23	Drug	TGA makes interim decision to reduce maximum paracetamol pack sizes.	Regulatory	Visit Page
Europe	European Medicines Agency	3-2-23	Drug	ICH guideline Q9 (R1) on quality risk management	Quality	Visit Page
USA	Food and Drug Administration	3-2-23	Medical Device	Total Product Life Cycle Advisory Program (TAP)	Regulatory	Visit Page
Europe	European Union	1-2-23	Medical Device	Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices	Regulatory	Visit Page
Europe	European Union	1-2-23	Medical Device	Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746	Regulatory	Visit Page
USA	Food and Drug Administration	1-2-23	Drug	Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (draft guidance)	Regulatory	Visit Page
USA	Food and Drug Administration	1-2-23	Drug	Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment (draft guidance)	Clinical	Visit Page
The Philippines	Philippines FDA	1-2-23	Drug	Guidelines on Food and Drug Administration’s Regulatory Responses During Declared National or State of Public Health Emergencies (draft guidance)	Regulatory	Visit Page
USA	Food and Drug Administration	1-2-23	Drug	Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development (draft guidance)	Clinical	Visit Page
USA	Food and Drug Administration	1-2-23	Drug	Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment (draft guidance)	Clinical	Visit Page
USA	Food and Drug Administration	1-2-23	Drug	Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (draft guidance)	Regulatory	Visit Page
Europe	European Medicines Agency	31-1-23	Drug	Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU	Clinical	Visit Page
USA	Food and Drug Administration	31-1-23	Medical Device	Surveying, Leveling, and Alignment Laser Products	Regulatory	Visit Page
Ireland	Health Products Regulatory Authority	30-1-23	Drug	Fees for Human Products	Regulatory	Visit Page
USA	Food and Drug Administration	27-1-23	Medical Device	Health Canada and FDA eSTAR Pilot	Regulatory	Visit Page
Europe	European Medicines Agency	26-1-23	Drug	ICH Guideline M13A on bioequivalence for immediate release solid oral dosage forms	Clinical	Visit Page
Mexico	COFEPRIS	25-1-23	Drug	Mexico proposes a Latin American Medicines Agency for health self-sufficiency	Regulatory	Visit Page
Europe	European Union	25-1-23	Medical Device	Scientific advice pilot for high-risk medical devices device	Regulatory	Visit Page
USA	Food and Drug Administration	24-1-23	Drug	Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Guidance for Industry; Availability	Clinical	Visit Page
UK	Medicines and Healthcare products Regulatory Agency	24-1-23	Drug	European Commission Decision Reliance Procedure (ECDRP) extension	Regulatory	Visit Page
Europe	European Medicines Agency	23-1-23	Drug	Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2023	Pharmacovigilance	Visit Page
USA	Food and Drug Administration	20-1-23	Medical Device	Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products	Regulatory	Visit Page
Europe	European Medicines Agency	20-1-23	Drug	Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines	Regulatory	Visit Page
USA	Food and Drug Administration	20-1-23	Medical Device	Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions	Regulatory	Visit Page
USA	Food and Drug Administration	20-1-23	Medical Device	Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye	Regulatory	Visit Page
USA	Food and Drug Administration	20-1-23	Medical Device	Radiological Health Regulations: Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products	Regulatory	Visit Page
Europe	European Medicines Agency	19-1-23	Drug	Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications	Clinical	Visit Page
USA	Food and Drug Administration	17-1-23	Medical Device	Classification of the Prognostic Test for Assessment of Liver Related Disease Progression	Regulatory	Visit Page
USA	Food and Drug Administration	13-1-23	Medical Device	Classification of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions	Regulatory	Visit Page
Malaysia	Medical Device Authority	13-1-23	Medical Device	Requirements for application of Certificate Of Free Sale (CFS), Manufacturing Certificate (MC) and Certificate Of Free Sale For Export only (CFS EO) medical devices (draft guidance)	Regulatory	Visit Page
USA	Food and Drug Administration	12-1-23	Medical Device	Photobiomodulation (PBM) Devices - 2 Premarket Notification [510(k)] 3 Submissions (draft guidance)	Regulatory	Visit Page
USA	Food and Drug Administration	12-1-23	Medical Device	Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice	Regulatory	Visit Page
Switzerland	The Swiss Agency for Therapeutic Products	11-1-23	Drug	Position paper by Swissmedic and swissethics on decentralized clinical trials (DCTs) with medicinal products	Clinical	Visit Page
Europe	European Union	6-1-23	Medical Device	Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation	Regulatory	Visit Page
Europe	European Union	6-1-23	Medical Device	More time to certify medical devices under MDR to mitigate risks of shortages	Regulatory	Visit Page
USA	Food and Drug Administration	5-1-23	Medical Device	Orthopedic Devices; Classification of the Bone Indentation Device	Regulatory	Visit Page
USA	Food and Drug Administration	5-1-23	Medical Device	Orthopedic Devices; Classification of the Implantable Post-Surgical Kinematic Measurement Knee Device	Regulatory	Visit Page
USA	Food and Drug Administration	5-1-23	Medical Device	Neurological Devices; Classification of the Brain Stimulation Programming Planning Software	Regulatory	Visit Page
New Zealand	New Zealand Medicines and Medical Devices Safety	3-1-23	Drug-Device Combination	Guideline on the Regulation of Therapeutic Products in New Zealand	Regulatory	Visit Page
The Philippines	Philippines FDA	3-1-23	Drug	Updated Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices (draft for comments)	Regulatory	Visit Page
The Philippines	Philippines FDA	3-1-23	Medical Device	Guidelines on the Conduct of Regulatory Inspections for Radiation Facilities	Regulatory	Visit Page
Europe	European Medicines Agency	3-1-23	Drug	Coordination of pharmacovigilance inspections	Pharmacovigilance	Visit Page
Europe	European Union	3-1-23	Medical Device	List of standard fees	Regulatory	Visit Page
Switzerland	The Swiss Agency for Therapeutic Products	3-1-23	Medical Device	MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured	Regulatory	Visit Page
Malaysia	National Pharmaceutical Regulatory Agency	3-1-23	Drug-Device Combination	Guideline for drug-medical device and medical device-drug combination products - endorsement letter application - adverse drug reaction and incident reporting	Regulatory	Visit Page
Europe	European Medicines Agency	3-1-23	Drug	Pharmeuropa 35.1 just released	Regulatory	Visit Page
USA	Food and Drug Administration	3-1-23	Medical Device	Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System	Regulatory	Visit Page
USA	Food and Drug Administration	1-1-23	Drug	Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (draft guidance)	Clinical	Visit Page
Malaysia	Medical Device Authority	1-1-23	Medical Device	How to submit an application for registration of a refurbished medical device	Regulatory	Visit Page
USA	Food and Drug Administration	1-1-23	Drug	Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (draft guidance)	Labeling	Visit Page
Europe	European Medicines Agency	1-1-23	Drug	Guidance on good manufacturing practice and good distribution practice: Questions and answers	Regulatory	Visit Page
Europe	European Union	1-1-23	Medical Device	Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746	Regulatory	Visit Page
Netherlands	Medicines Evaluation Board	1-1-23	Drug	Changes to fees for human medicinal products and devices as of 1 January 2023	Regulatory	Visit Page
USA	Food and Drug Administration	1-1-23	Format and Content of a REMS Document	Format and Content of a REMS Document	Safety	Visit Page
USA	Food and Drug Administration	30-12-22	Medical Device	Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid	Regulatory	Visit Page
USA	Food and Drug Administration	28-12-22	Medical Device	Classification of the Interventional Cardiovascular Implant Simulation Software Device	Regulatory	Visit Page
USA	Food and Drug Administration	27-12-22	Medical Device	Classification of the Adjunctive Hemodynamic Indicator with Decision Point	Regulatory	Visit Page
USA	Food and Drug Administration	23-12-22	Drug	FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs	Regulatory	Visit Page
USA	Food and Drug Administration	22-12-22	Drug	Controlled Correspondence Related to Generic Drug Development (draft guidance)	Regulatory	Visit Page
International	The International Council for Harmonisation	20-12-22	Drug	Bioequivalence for immediate release solid oral dosage forms M13A	Regulatory	Visit Page
USA	Food and Drug Administration	20-12-22	Medical Device	Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices	Safety	Visit Page
Global	International Medical Device Regulators Forum	19-12-22	Medical Device	IMDRF Standard Operating Procedures	Regulatory	Visit Page
Europe	European Medicines Agency	16-12-22	Drug	EMA Management Board: highlights of December 2022 meeting	Regulatory	Visit Page
Europe	European Union	16-12-22	Medical Device	Guidance on Periodic Safety Update Report (PSUR) according to regulation (EU) 2017/745 (MDR)	Safety	Visit Page
USA	Food and Drug Administration	15-12-22	Drug	Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (draft guidance)	Regulatory	Visit Page
USA	Food and Drug Administration	15-12-22	Drug	Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (draft guidance)	Regulatory	Visit Page
Singapore	Health Sciences Authority	14-12-22	Drug	Mean applicant screening response time	Regulatory	Visit Page
USA	Food and Drug Administration	14-12-22	Drug	FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal	Labeling	Visit Page
USA	Food and Drug Administration	14-12-22	Drug	Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe	Regulatory	Visit Page
Europe	European Union	14-12-22	Medical Device	Substantial modification of performance study under Regulation (EU) 2017/746	Regulatory	Visit Page
India	Central Drugs Standard Control Organisation	13-12-22	Drug	Inspections/Audits of Pharmacovigilance (PV) system of importers and manufacturers of human vaccine	Pharmacovigilance	Visit Page
Europe	European Union	13-12-22	Drug	Commission proposes updated EMA fees	Regulatory	Visit Page
USA	Food and Drug Administration	9-12-22	Drug	Pulmonary Tuberculosis: Developing Drugs for Treatment (draft guidance)	Clinical	Visit Page
Australia	Therapeutic Goods Administration	9-12-22	Drug	Safety advisory - Low levels of contamination with N-nitroso-quinapril	Safety	Visit Page
USA	Food and Drug Administration	9-12-22	Medical Device	Content of Human Factors Information in Medical Device Marketing Submissions (draft guidance)	Regulatory	Visit Page
USA	Food and Drug Administration	9-12-22	Drug	CMC Reviews of Type III DMFs for Packaging Materials	Packaging	Visit Page
USA	Food and Drug Administration	9-12-22	Drug	Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria	Regulatory	Visit Page
USA	Food and Drug Administration	9-12-22	Medical Device	Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers (draft guidance)	Regulatory	Visit Page
USA	Food and Drug Administration	8-12-22	Drug	Acceptability of Standards from Alternative Compendia (BP/EP/JP)	Regulatory	Visit Page
Europe	European Union	8-12-22	Medical Device	MDCG position paper on ‘hybrid audits’	Regulatory	Visit Page
India	Central Drugs Standard Control Organisation	7-12-22	Drug	Changes to pharmaceutical database based on feedback received	Regulatory	Visit Page
USA	Food and Drug Administration	7-12-22	Medical Device	Augmented Reality and Virtual Reality in Medical Devices	Regulatory	Visit Page
USA	Food and Drug Administration	7-12-22	Drug	Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q)	Regulatory	Visit Page
Europe	European Union	6-12-22	Medical Device	Proposal to delay the implementation of the Medical Device Regulation	Regulatory	Visit Page
USA	Food and Drug Administration	6-12-22	Drug	Homeopathic Drug Products	Regulatory	Visit Page
USA	Food and Drug Administration	5-12-22	Drug	E19 A selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials	Clinical	Visit Page
UK	Medicines and Healthcare products Regulatory Agency	5-12-22	Medical Device	Guidance for manufacturers on vigilance	Pharmacovigilance	Visit Page
USA	Food and Drug Administration	5-12-22	Drug	Statistical Approaches to Establishing Bioequivalence (draft guidance)	Regulatory	Visit Page
Europe	European Union	2-12-22	Medical Device	Regulations to lay down common specifications and rules for reclassification of products without an intended medical purpose under the Medical Devices Regulation (MDR)	Regulatory	Visit Page
Europe	European Medicines Agency	2-12-22	Drug	EMA recommends withdrawal of pholcodine medicines from EU market	Regulatory	Visit Page
USA	Food and Drug Administration	2-12-22	Drug	ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (draft guidance)	Regulatory	Visit Page
Australia	Therapeutic Goods Administration	30-11-22	Drug	A warning that advertising Ozempic (semaglutide) is prohibited	Labeling	Visit Page
Ireland	Health Products Regulatory Authority	28-11-22	Drug	Update on review of over-the-counter medicines containing codeine.	Regulatory	Visit Page
Malaysia	Medical Device Authority	21-11-22	Medical Device	Change notification for registered medical device	Regulatory	Visit Page
Malaysia	Medical Device Authority	21-11-22	Medical Device	Requirements for labelling of medical devices	Labeling	Visit Page
USA	Food and Drug Administration	17-11-22	Drug	Upcoming Product-Specific Guidances for Generic Drug Product Development	Regulatory	Visit Page
Global	INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE	16-11-22	Drug	Continuous manufacturing of drug substances and drug products Q13	Regulatory	Visit Page
USA	Food and Drug Administration	15-11-22	Drug	FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use	Regulatory	Visit Page
Australia	Therapeutic Goods Administration	15-11-22	Medical Device	Post-market review of ventilators, CPAP and BiPAP devices	Pharmacovigilance	Visit Page
USA	Food and Drug Administration	14-11-22	Medical Device	Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents	Regulatory	Visit Page
Europe	European Medicines Agency	10-11-22	Biologics	Reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances	Regulatory	Visit Page
Indonesia	BADAN POM	9-11-22	Drug	Explanation of BPOM RI number HM.01.1.2.11.22.178 dated 9 November 2022 regarding development of results of supervision of drug syrup and procedure of propylene glycol raw materials containing contaminants EG and DEG exceed the limits	Regulatory	Visit Page
Malaysia	Medical Device Authority	9-11-22	Medical Device	Notification of custom-made medical device - Guidance document	Regulatory	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
Australia	Therapeutic Goods Administration	7-11-22	Drug	International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names	Labeling	Visit Page
UK	Medicines and Healthcare products Regulatory Agency	7-11-22	Biologics	Guidance on the licensing of biosimilar products	Regulatory	Visit Page
Switzerland	The Swiss Agency for Therapeutic Products	4-11-22	Drug	Changes to the Guidance document Variations TAM HMV4	Regulatory	Visit Page
Europe	European Medicines Agency	3-11-22	Drug	Regulatory update - EMA encourages companies to submit type I variations for 2022 by end of November	Regulatory	Visit Page
Australia	Therapeutic Goods Administration	3-11-22	Medical Device	Post-market review of spinal cord stimulation (SCS) devices	Pharmacovigilance	Visit Page
The Philippines	Philippines FDA	1-11-22	Drug	Guidelines Prescribing the Principle of Reliance for Regulatory Decisions of the Food and Drug Administration	Regulatory	Visit Page
The Philippines	Philippines FDA	1-11-22	Drug	Guidelines on Food and Drug Administration’s Regulatory Responses During Declared National Public Health Emergencies	Regulatory	Visit Page
USA	Food and Drug Administration	1-11-22	Drug	Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act	Regulatory	Visit Page
USA	Food and Drug Administration	1-11-22	Drug	Sameness Evaluations in an ANDA — Active Ingredients (draft guidance)	Regulatory	Visit Page
USA	Food and Drug Administration	1-11-22	Biologics	Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)	Regulatory	Visit Page
USA	Food and Drug Administration	1-11-22	Drug	M10 Bioanalytical method validation and study sample analysis	Regulatory	Visit Page
USA	Food and Drug Administration	1-11-22	Drug	Cross Labeling Oncology Drugs in Combination Regimens	Labeling	Visit Page
USA	Food and Drug Administration	1-11-22	Drug	S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals	Non-Clinical	Visit Page
USA	Food and Drug Administration	1-11-22	Biologics	Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial	Clinical	Visit Page
USA	Food and Drug Administration	1-11-22	Drug	Expanded Access to Investigational Drugs for Treatment Use Questions and Answers (draft guidance)	Regulatory	Visit Page
USA	Food and Drug Administration	31-10-22	Drug	Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement	CMC	Visit Page
Europe	European Union	28-10-22	Drug	The Council of Europe/EDQM and the European Union conclude an agreement expanding the scope of their co-operation in the field of substances of human origin	Regulatory	Visit Page
China	National Medical Products Administration	27-10-22	Drug	NMPA Announcement on putting into use the electronic certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product	Regulatory	Visit Page
India	Central Drugs Standard Control Organisation	27-10-22	Drug	IPC's Notice Regarding General Chapters of IP 2022	Regulatory	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	19-10-22	Drug	Advancing Real-World Evidence Program	Regulatory	Visit Page
Europe	European Medicines Agency	18-10-22	Drug	Anonymization of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6)	Pharmacovigilance	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	Prioritization of the Review of Original ANDAs, Amendments, and Supplements	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	Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (draft guidance)	Regulatory	Visit Page
Europe	European Union	3-10-22	Medical Device	Guidance on Authorized Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)	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
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	Policy for Monkeypox Tests to Address the Public Health Emergency, Guidance for Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff	Regulatory	Visit Page
Switzerland	The Swiss Agency for Therapeutic Products	14-9-22	Drug	Potential nitrosamine contamination – harmonised implementation (update)	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
Europe	European Commission	8-9-22	Medical Device	Medical devices - reclassification of products without an intended medical purpose	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
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
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
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
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
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
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