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

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Country/Region	Health Authority	Date of Publishing	Product Type	Topic	Domain	URL
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