Skip to main content Skip to search Skip to main navigation

EMA and Korean MFDS share confidential COVID-19 information

EMA and the Korean Ministry of Food and Drug Safety (MFDS) have signed an agreement to exchange confidential information on medicines for the treatment, diagnosis or prevention of COVID-19.

The agreement with MFDS is an ad-hoc arrangement that focuses exclusively on COVID-19. Ad hoc agreements have a limited scope and duration and allow for the possibility to respond to specific situations. The EMA and the MFDS can thus exchange certain information without having to negotiate far-reaching, permanent confidentiality agreements. The agreement with Korea complements existing agreements with countries such as Switzerland, Canada, Japan or organisations as the EDQM and the WHO.

Pharmaceutical authorities worldwide are given the opportunity to discuss political approaches in connection with COVID-19 and regulatory adjustments through the International Coalition of Medicines Regulatory Authorities (ICMRA), which is currently chaired by the EMA. The development and approval of COVID-19 drugs and vaccines should thus be accelerated. Regular virtual meetings are being held.


Source:

EMA: News and Events
 

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

ANVISA: Expands Recognition of Foreign GMP Authorities

ANVISA: Expands Recognition of Foreign GMP Authorities

Brazilian health authority ANVISA has updated the requirements for the recognition of Equivalent Foreign Regulatory Authorities (AREE) and the administrative procedures for Good Manufacturing Practice (GMP) certification (CBPF) through Normative Instruction IN 451/2026. The aim is to streamline and accelerate regulatory processes.
Read more
EDQM: Guidance on Reporting on Disappearances of Medicinal Products

EDQM: Guidance on Reporting on Disappearances of Medicinal Products

The EDQM has published guidance supporting the implementation of Recommendation CM/Rec(2024)3 on reporting medicinal products that disappear from the legal supply chain due to theft, loss or diversion. The initiative follows a European survey that identified shortcomings in reporting and co-ordination of such incidents.

Read more
Damage Control: Complaints and Recalls

Damage Control: Complaints and Recalls

Complaint handling and product recalls are important components of the Pharmaceutical Quality System (PQS). They serve to identify defective medicinal products and ensure that appropriate measures are taken to protect patient safety, as required by law and the competent supervisory authority.

Read more
What are the Phases of a Working Cycle During a Steam Sterilisation Process?

What are the Phases of a Working Cycle During a Steam Sterilisation Process?

Here's the answer:
Read more
EMA: 9 New Nitrosamines for Appendix 1

EMA: 9 New Nitrosamines for Appendix 1

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.
Read more
EMA: Reduced Testing of Incoming Starting Materials is a GMP Matter

EMA: Reduced Testing of Incoming Starting Materials is a GMP Matter

The European Medicines Agency (EMA) published an update to its “Quality of Medicines: Questions and Answers – Part 2”. The revision concerns the section on “Reduced testing of incoming starting materials”.
Read more
Previous
Next