News about GMP/cGMP

17.04.2020

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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