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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

Country/Region

New Zealand

Date of Publishing

15-4-21

Product Type

Drugs

Topic

Outcome of the consultation on the proposed changes to paracetamol warning and advisory statements

Domain

Labeling

URL

Country/Region

Switzerland

Date of Publishing

1-4-21

Product Type

Medical Devices

Topic

New requirements and changes to authorisation practice as of May 2021

Domain

Registration

URL

Country/Region

USA

Date of Publishing

25-3-21

Product Type

Drugs

Topic

Upcoming Product-Specific Guidances for Complex Generic Drug Product Development

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

24-3-21

Product Type

Vaccines

Topic

New procedure to facilitate and speed up approval of adapted vaccines against Covid-19 variants

Domain

Registration

URL

Country/Region

The Philippines

Date of Publishing

23-3-21

Product Type

Vaccines

Topic

Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection

Domain

Registration

URL

Country/Region

UK

Date of Publishing

23-3-21

Product Type

Drug-Device Combination

Topic

MHRA pilots patient involvement in new applications

Domain

Registration

URL

Country/Region

UK

Date of Publishing

19-3-21

Product Type

Drug-Device Combination

Topic

Guidance for industry on MHRA's expectations for return to UK on-site inspections

Domain

General

URL

Country/Region

Europe

Date of Publishing

17-3-21

Product Type

Drugs

Topic

SWP response to CMDh questions on chlorobutanol

Domain

General

URL

Country/Region

USA

Date of Publishing

17-3-21

Product Type

Topic

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premark Review Process

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

17-3-21

Product Type

Drugs

Topic

Rapid implementation of the revised sartan monographs on 1 April 2021

Domain

Registration

URL

Country/Region

USA

Date of Publishing

16-3-21

Product Type

Medical Devices

Topic

Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions

Domain

Real-World Evidence

URL

Country/Region

Europe

Date of Publishing

15-3-21

Product Type

Vaccines

Topic

EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update

Domain

Product Vigilance

URL

Country/Region

Canada

Date of Publishing

12-3-21

Product Type

Drugs

Topic

"Electronic media in prescription drug labelling"

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

12-3-21

Product Type

Vaccines

Topic

Labelling flexibilities for COVID-19 therapeutics

Domain

Labeling

URL

Country/Region

India

Date of Publishing

12-3-21

Product Type

Devices

Topic

Change in medical device pricing

Domain

General

URL

Country/Region

Europe

Date of Publishing

11-3-21

Product Type

Drugs

Topic

How CEP holders can avoid the rejection of notifications

Domain

Registration

URL

Country/Region

Australia

Date of Publishing

10-3-21

Product Type

Vaccines

Topic

COVID-19 vaccines - safety and effectiveness in older adults

Domain

Product Vigilance

URL

Country/Region

India

Date of Publishing

10-3-21

Product Type

Vaccines

Topic

Recommendations of the SEC meeting to examine COVID-19 related proposal under accelerated approval process

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

10-3-21

Product Type

Vaccines

Topic

"Guidance on state of the art of COVID-19 rapid antibody tests"

Domain

General

URL

Country/Region

Australia

Date of Publishing

9-3-21

Product Type

Devices

Topic

IMDRF consultation: Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

Domain

Registration

URL

Country/Region

Ireland

Date of Publishing

9-3-21

Product Type

Drug-Device Combination

Topic

"Guide to New Applications and Variations to Wholesale Distribution Authorisations"

Domain

Regulatory Information

URL

Country/Region

UK

Date of Publishing

9-3-21

Product Type

Drugs

Topic

Importing medicines into Northern Ireland before 31 December 2021

Domain

Regulatory Information

URL

Country/Region

Ireland

Date of Publishing

9-3-21

Product Type

Drugs

Topic

Good Distribution Practice of Medicinal Products for Human Use

Domain

General

URL

Country/Region

Europe

Date of Publishing

5-3-21

Product Type

Drugs

Topic

Handling of duplicate marketing authorisation applications of pharmaceutical products under Article 82(1) of Regulation (EC) No 726/2004

Domain

Registration

URL

Country/Region

USA

Date of Publishing

4-3-21

Product Type

Vaccines

Topic

COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers

Domain

Regulatory Information

URL

Country/Region

UK

Date of Publishing

4-3-21

Product Type

Vaccines

Topic

Guidance on strain changes in authorised COVID-19 vaccines

Domain

General

URL

Country/Region

Europe

Date of Publishing

3-3-21

Product Type

Drugs

Topic

"Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices"

Domain

General

URL

Country/Region

USA

Date of Publishing

3-3-21

Product Type

Topic

Data Modernization Action Plan

Domain

URL

Country/Region

Europe

Date of Publishing

3-3-21

Product Type

Drugs

Topic

EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)

Domain

General

URL

Country/Region

Europe

Date of Publishing

1-3-21

Product Type

Drugs

Topic

Revision of CEPs referring to one of the "sartan” monographs following their rapid implementation

Domain

Regulatory Information

URL

Country/Region

Malaysia

Date of Publishing

1-3-21

Product Type

Drugs

Topic

Guidance Notes Updated API information for product registration

Domain

Regulatory Information

URL

Country/Region

Australia

Date of Publishing

26-2-21

Product Type

Devices

Topic

Consultation: Proposed regulatory options for medical devices containing nanomaterials (for comments)

Domain

Regulatory Information

URL

Country/Region

UK

Date of Publishing

26-2-21

Product Type

Drugs

Topic

First Innovation Passport awarded to help support development and access to cutting-edge medicines

Domain

Registration

URL

Country/Region

Australia

Date of Publishing

25-2-21

Product Type

Medical Devices

Topic

Regulatory changes for software based medical devices

Domain

Registration

URL

Country/Region

Australia

Date of Publishing

24-2-21

Product Type

Drug-Device Combination

Topic

The TGA's risk management approach

Domain

Product Vigilance

URL

Country/Region

Europe

Date of Publishing

23-2-21

Product Type

Vaccines

Topic

"Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2"

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory Information

URL

Country/Region

USA

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

Domain

General

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory Information

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory Information

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory Information

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory Information

URL

Country/Region

USA

Date of Publishing

19-2-21

Product Type

Medical Devices

Topic

Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

Domain

Product Vigilance

URL

Country/Region

Malaysia

Date of Publishing

18-2-21

Product Type

Drug-Device Combination

Topic

Guidance Document Foreign GMP Inspection

Domain

General

URL

Country/Region

UK

Date of Publishing

17-2-21

Product Type

Drug-Device Combination

Topic

How investigators and sponsors should manage clinical trials during COVID-19

Domain

General

URL

Country/Region

USA

Date of Publishing

16-2-21

Product Type

Medical Devices

Topic

"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"

Domain

General

URL

Country/Region

Europe

Date of Publishing

15-2-21

Product Type

Medical Devices

Topic

Management of Legacy Devices MDR EUDAMED

Domain

General

URL

Country/Region

India

Date of Publishing

12-2-21

Product Type

Drugs

Topic

Application for retail price fixation of new drugs through email only

Domain

General

URL

Country/Region

Europe

Date of Publishing

11-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory Information

URL

Country/Region

Denmark

Date of Publishing

10-2-21

Product Type

Vaccines

Topic

Danish Medicines Agency expands capacity for safety monitoring of Covid-19 vaccines

Domain

Product Vigilance

URL

Country/Region

UK

Date of Publishing

9-2-21

Product Type

Drugs

Topic

Access New Active Substance (NAS) Work Sharing Initiative

Domain

General

URL

Country/Region

Europe

Date of Publishing

4-2-21

Product Type

Drugs

Topic

Guidance on the management of clinical trials during the Covid-19 (coronavirus) pandemic

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

4-2-21

Product Type

Vaccines

Topic

FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

3-2-21

Product Type

Drugs

Topic

"Questions and Answers on the Pilot Project 'OPEN' - Opening our Procedures at EMA to Non-EU authorities"

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

3-2-21

Product Type

Drugs

Topic

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

Domain

Product Vigilance

URL

Country/Region

International

Date of Publishing

3-2-21

Product Type

Drugs

Topic

WHO announces updated critical concentrations for susceptibility testing to rifampicin

Domain

General

URL

Country/Region

Europe

Date of Publishing

2-2-21

Product Type

Drugs

Topic

Draft toolbox guidance on scientific elements and 5 regulatory tools to support quality data packages for 6 PRIME marketing authorization applications

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

1-2-21

Product Type

Devices

Topic

"Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional"

Domain

Registration

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Vaccines

Topic

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Vaccines

Topic

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

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Medical Devices

Topic

Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Vaccines

Topic

COVID-19 vaccine safety monitoring plan

Domain

Product Vigilance

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Drugs

Topic

2020 CDER Annual Report

Domain

General

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Drugs

Topic

Fees and charges proposal 2021-22

Domain

Registration

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Drugs

Topic

Repurposing of Prescription Medicines

Domain

Labeling

URL

Country/Region

UK

Date of Publishing

1-2-21

Product Type

Drugs

Topic

Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)

Domain

Product Vigilance

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Drugs

Topic

Safety advisory - enhanced warnings relating Safety advisory - enhanced warnings relating

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

1-2-21

Product Type

Drugs

Topic

Nitrosamine impurity check extends to Rifampicin

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

29-1-21

Product Type

Drugs

Topic

Manufacturing, Supply Chain, and Drug Inspections - COVID-19

Domain

CMC

URL

Country/Region

Australia

Date of Publishing

29-1-21

Product Type

Medical Devices

Topic

Emergency COVID-19 exemptions end for ventilators and personal protective equipment

Domain

General

URL

Country/Region

The Philippines

Date of Publishing

13-1-21

Product Type

Drugs

Topic

Revised guidelines on the cold chain Revised guidelines on the cold chain Revised guidelines on the cold chain and establishments

Domain

Labeling

URL

Country/Region

Malaysia

Date of Publishing

1-1-21

Product Type

Medicine

Topic

Drug Registration Guidance Document (DRGD)

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

1-1-21

Product Type

Drug-Device Combination

Topic

"Pilot phase for CHMP early contact with patient / consumer organisations"

Domain

Clinical

URL

Country/Region

International

Date of Publishing

1-1-70

Product Type

Medical Devices

Topic

Selection, access and use of in vitro diagnostics

Domain

General

URL

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