
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.

Regulatory Updates
Country/Region | Health Authority | Date of Publishing | Product Type | Topic | Domain | URL |
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New Zealand | New Zealand Medicines and Medical Devices Safety | 15-4-21 | Drugs | Outcome of the consultation on the proposed changes to paracetamol warning and advisory statements | Labeling | Visit Page |
Switzerland | SwissMedic | 1-4-21 | Medical Devices | New requirements and changes to authorisation practice as of May 2021 | Registration | Visit Page |
USA | Food and Drug Administration | 25-3-21 | Drugs | Upcoming Product-Specific Guidances for Complex Generic Drug Product Development | Registration | Visit Page |
Europe | European Commission | 24-3-21 | Vaccines | New procedure to facilitate and speed up approval of adapted vaccines against Covid-19 variants | Registration | Visit Page |
The Philippines | Philippines FDA | 23-3-21 | Vaccines | Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection | Registration | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 23-3-21 | Drug-Device Combination | MHRA pilots patient involvement in new applications | Registration | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 19-3-21 | Drug-Device Combination | Guidance for industry on MHRA's expectations for return to UK on-site inspections | General | Visit Page |
Europe | European Medicines Agency | 17-3-21 | Drugs | SWP response to CMDh questions on chlorobutanol | General | Visit Page |
USA | Food and Drug Administration | 17-3-21 | FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premark Review Process | Registration | Visit Page | |
Europe | European Directorate for the Quality of Medicines and Healthcare | 17-3-21 | Drugs | Rapid implementation of the revised sartan monographs on 1 April 2021 | Registration | Visit Page |
USA | Food and Drug Administration | 16-3-21 | Medical Devices | Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions | Real-World Evidence | Visit Page |
Europe | European Medicines Agency | 15-3-21 | Vaccines | EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update | Product Vigilance | Visit Page |
Canada | Health Canada | 12-3-21 | Drugs | "Electronic media in prescription drug labelling" | Labeling | Visit Page |
Europe | European Medicines Agency | 12-3-21 | Vaccines | Labelling flexibilities for COVID-19 therapeutics | Labeling | Visit Page |
India | National Pharmaceutical Pricing Authority | 12-3-21 | Devices | Change in medical device pricing | General | Visit Page |
Europe | European Directorate for the Quality of Medicines and Healthcare | 11-3-21 | Drugs | How CEP holders can avoid the rejection of notifications | Registration | Visit Page |
Australia | Therapeutic Goods Administration | 10-3-21 | Vaccines | COVID-19 vaccines - safety and effectiveness in older adults | Product Vigilance | Visit Page |
India | Central Drugs Standard OrganisationControl | 10-3-21 | Vaccines | Recommendations of the SEC meeting to examine COVID-19 related proposal under accelerated approval process | Registration | Visit Page |
Europe | European Commission | 10-3-21 | Vaccines | "Guidance on state of the art of COVID-19 rapid antibody tests" | General | Visit Page |
Australia | Therapeutic Goods Administration | 9-3-21 | Devices | IMDRF consultation: Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews | Registration | Visit Page |
Ireland | Health Products Regulatory Authority | 9-3-21 | Drug-Device Combination | "Guide to New Applications and Variations to Wholesale Distribution Authorisations" | Regulatory Information | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 9-3-21 | Drugs | Importing medicines into Northern Ireland before 31 December 2021 | Regulatory Information | Visit Page |
Ireland | Health Products Regulatory Authority | 9-3-21 | Drugs | Good Distribution Practice of Medicinal Products for Human Use | General | Visit Page |
Europe | European Commission | 5-3-21 | Drugs | Handling of duplicate marketing authorisation applications of pharmaceutical products under Article 82(1) of Regulation (EC) No 726/2004 | Registration | Visit Page |
USA | Food and Drug Administration | 4-3-21 | Vaccines | COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers | Regulatory Information | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 4-3-21 | Vaccines | Guidance on strain changes in authorised COVID-19 vaccines | General | Visit Page |
Europe | European Commission | 3-3-21 | Drugs | "Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices" | General | Visit Page |
USA | Food and Drug Administration | 3-3-21 | Data Modernization Action Plan | Visit Page | ||
Europe | European Medicines Agency | 3-3-21 | Drugs | EMA issues advice on use of antibody combination (bamlanivimab / etesevimab) | General | Visit Page |
Europe | European Directorate for the Quality of Medicines and Healthcare | 1-3-21 | Drugs | Revision of CEPs referring to one of the "sartan” monographs following their rapid implementation | Regulatory Information | Visit Page |
Malaysia | National Pharmaceutical Regulatory Agency | 1-3-21 | Drugs | Guidance Notes Updated API information for product registration | Regulatory Information | Visit Page |
Australia | Therapeutic Goods Administration | 26-2-21 | Devices | Consultation: Proposed regulatory options for medical devices containing nanomaterials (for comments) | Regulatory Information | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 26-2-21 | Drugs | First Innovation Passport awarded to help support development and access to cutting-edge medicines | Registration | Visit Page |
Australia | Therapeutic Goods Administration | 25-2-21 | Medical Devices | 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 | Product Vigilance | Visit Page |
Europe | European Medicines Agency | 23-2-21 | Vaccines | "Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2" | Registration | Visit Page |
Europe | European Medicines Agency | 22-2-21 | Drug-Device Combination | Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe | Regulatory Information | 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 Information | 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 Information | 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 Information | 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 Information | Visit Page |
USA | Food and Drug Administration | 19-2-21 | Medical Devices | Pulse Oximeter Accuracy and Limitations: FDA Safety Communication | Product Vigilance | 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 Devices | "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 Devices | Management of Legacy Devices MDR EUDAMED | General | Visit Page |
India | National Pharmaceutical Pricing Agency | 12-2-21 | Drugs | 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 Information | Visit Page |
Denmark | Danish Medicines Agency | 10-2-21 | Vaccines | Danish Medicines Agency expands capacity for safety monitoring of Covid-19 vaccines | Product Vigilance | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 9-2-21 | Drugs | Access New Active Substance (NAS) Work Sharing Initiative | General | Visit Page |
Europe | European Medicines Agency | 4-2-21 | Drugs | Guidance on the management of clinical trials during the Covid-19 (coronavirus) pandemic | Clinical | Visit Page |
USA | Food and Drug Administration | 4-2-21 | Vaccines | FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data | Labeling | Visit Page |
Europe | European Medicines Agency | 3-2-21 | Drugs | "Questions and Answers on the Pilot Project 'OPEN' - Opening our Procedures at EMA to Non-EU authorities" | Registration | Visit Page |
Europe | European Medicines Agency | 3-2-21 | Drugs | 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 | Product Vigilance | Visit Page |
International | World Health Organization | 3-2-21 | Drugs | WHO announces updated critical concentrations for susceptibility testing to rifampicin | General | Visit Page |
Europe | European Medicines Agency | 2-2-21 | Drugs | Draft toolbox guidance on scientific elements and 5 regulatory tools to support quality data packages for 6 PRIME marketing authorization applications | Registration | Visit Page |
Europe | European Commission | 1-2-21 | Devices | "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 | Vaccines | COVID-19: Developing Drugs and Biological Products for Treatment or Prevention | Clinical | Visit Page |
USA | Food and Drug Administration | 1-2-21 | Vaccines | 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 | Medical Devices | Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests | Clinical | Visit Page |
Australia | Therapeutic Goods Administration | 1-2-21 | Vaccines | COVID-19 vaccine safety monitoring plan | Product Vigilance | Visit Page |
USA | Food and Drug Administration | 1-2-21 | Drugs | 2020 CDER Annual Report | General | Visit Page |
Australia | Therapeutic Goods Administration | 1-2-21 | Drugs | Fees and charges proposal 2021-22 | Registration | Visit Page |
Australia | Therapeutic Goods Administration | 1-2-21 | Drugs | Repurposing of Prescription Medicines | Labeling | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 1-2-21 | Drugs | Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) | Product Vigilance | Visit Page |
Australia | Therapeutic Goods Administration | 1-2-21 | Drugs | Safety advisory - enhanced warnings relating Safety advisory - enhanced warnings relating | Labeling | Visit Page |
Europe | European Medicines Agency | 1-2-21 | Drugs | Nitrosamine impurity check extends to Rifampicin | Labeling | Visit Page |
USA | Food and Drug Administration | 29-1-21 | Drugs | Manufacturing, Supply Chain, and Drug Inspections - COVID-19 | CMC | Visit Page |
Australia | Therapeutic Goods Administration | 29-1-21 | Medical Devices | Emergency COVID-19 exemptions end for ventilators and personal protective equipment | General | Visit Page |
The Philippines | Philippines Food and Drug Administration | 13-1-21 | Drugs | 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 |
International | World Health Organization | 1-1-70 | Medical Devices | Selection, access and use of in vitro diagnostics | General | Visit Page |
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