News about GMP/cGMP

03.07.2020

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.