EU Moves To Ease Regulatory Burden On Pharma
Authorities Allow Flexibility During COVID-19 Pandemic
Regulatory authorities have adapted the EU medicines framework to help pharmaceutical companies cope with the consequences of the COVID-19 pandemic.
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The coronavirus could have serious adverse effects on regulatory procedures at both European Medicines Agency and EU member state level. A new business continuity plan describes how procedures will be prioritized if problems arise.
Drug companies unable to continue with standard reporting of suspected adverse reactions to the EU pharmacovigilance database can temporarily prioritize their reporting activities to focus on COVID-19 related safety events.
Dozens of life science companies are working to find effective treatments for COVID-19. In addition to our daily in-depth coverage of key regulatory events relating to the coronavirus pandemic, we’re bringing you selected brief insights into some of the efforts that are under way on this front.