EMA and COVID-19: Task Force and Q&A on flexible regulatory requirements for pharmaceutical companies
The European Commission, the EMA and the European Medicines Regulatory Network have developed a 7-page Q&A to guide pharmaceutical companies in making flexible adjustments to the regulatory framework during the COVID 19 pandemic. The EMA has established a task force for this purpose, to take quick and coordinated regulatory action.
The Q&A document provides guidance to MAHs (marketing authorisation holders) of medicinal products on regulatory expectations and flexibility during the COVID-19 pandemic. The document will be updated to address new questions and to adjust the content to the evolution of the pandemic.For queries related to specific products that arenot specifically addressed in this document, MAHs are invited to address the EMA (for centrally authorised products) or the relevant national competent authorities (for nationally authorised products).
Marketing authorisation holders are advised to regularly check the EMA-page on COVID-19 for any new information.
Source
EMA: News
EMA: Task Force
EMA: Q&A on flexible regulatory requirements
EMA: COVID-19 page
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