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:

FDA: New Draft Guidance on Impurity Specifications for Antibiotics

FDA: New Draft Guidance on Impurity Specifications for Antibiotics

The US FDA has issued a new draft guidance (April 2026) on Impurity Specifications for Antibiotics.
Read more
EDQM: Guidance on Traceability of Medicines in Hospitals

EDQM: Guidance on Traceability of Medicines in Hospitals

The EDQM has published new guidance on the traceability of medicines in hospital settings. The aim is to improve traceability up to the point of administration and strengthen patient safety.
Read more
Contamination Control Strategy (CCS) – Not Just an Extended Site Master File

Contamination Control Strategy (CCS) – Not Just an Extended Site Master File

At the GMP-PharmaCongress in Wiesbaden, GMP inspector Frank Sielaff (Regional Authority in Darmstadt, Germany) shared practical insights from recent inspections, high-lighting deficiencies in CCS implementation.

Read more
Which Measures are Crucial for Implementation and Monitoring of Data Integrity?

Which Measures are Crucial for Implementation and Monitoring of Data Integrity?

Here's the answer:
Read more
EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals

EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals

In their „Horizon Scanning Report“, EMA and HMA have recommended updates to the regulatory framework to keep pace with developments in radiopharmaceuticals. Due to their unique characteristics these products require specific regulatory and scientific approaches.
Read more
GMP Meets Radiation Protection – How Do They Fit Together?

GMP Meets Radiation Protection – How Do They Fit Together?

The manufacture of radiopharmaceuticals requires simultaneous compliance with the EU GMP Guide and radiation protection regulations, which can lead to conflicting objectives between product safety and personal protection. Technical solutions such as negative pressure systems and lead-lined cells, as well as early consultation with the authorities, are crucial for implementation that complies with both GMP and radiation protection requirements.
Read more
Previous
Next