Global Regulatory Workshop on COVID-19 Real-World Evidence and Observational Studies
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Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main topics...
EMA Finalises Opinion on Presence of Nitrosamines in Medicines
EMA’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines in human...
International Regulators Align Positions on Phase 3 COVID-19 Vaccine Trials
Medicines regulatory authorities from around the world have published a report today highlighting the outcomes of the second workshop on...
EMA and Korean Ministry of Food and Drug Safety to Share Confidential COVID-19 Information
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...
Global Regulators Discuss Data Requirements for Phase 3 Trials of COVID-19 Vaccines
Under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed COVID-19...
European Regulators Make Recommendations Drawing on Lessons Learnt From Presence of Nitrosamines in Sartan Medicines
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The European medicines regulatory network has issued recommendations on impurities in medicines following the conclusion of an exercise to...
Global Regulators Work Towards Alignment on Policy Approaches and Regulatory Flexibility During COVID-19 – Update #4
The International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular virtual meeting of regulators from around the world...
EMA Receives Application for Conditional Authorisation of First COVID-19 Treatment in the EU
EMA has now received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of...



