EMA and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have signed an agreement that allows them to share confidential information on medicines intended for the treatment, diagnosis, or prevention of COVID-19.
COVID-19 is a global public health emergency. EMA is committed to working with international regulators to help streamline the regulatory requirements for the generation of evidence for COVID-19 therapeutics and medicines to help speed up their development in the interest of patients worldwide.
The agreement with MFDS is an ad-hoc arrangement that focuses exclusively on COVID-19. It complements EMA’s standing confidentiality arrangements with other countries and organisations.
The high-level, strategic coordination between global regulators is taking place through the International Coalition of Medicines Regulatory Authorities (ICMRA), which is currently chaired by EMA. As part of this work, ICMRA is holding bi-weekly meetings to allow medicine regulatory authorities worldwide to discuss COVID-19-related policy approaches and regulatory flexibility, with the aim of expediting COVID-19 medicine and vaccine development and approval and avoiding medicine shortages.
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