EU Allows ‘Freezing’ & ‘Rolling Back’ Of Regulatory Timelines Due To COVID-19
Guidance is now available to help drug companies that use the EU mutual recognition and decentralized procedures to handle regulatory processes during the COVID-19 crisis.
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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.
While inspection interviews can be stressful for drug firms, a Dutch pharmacovigilance inspector reassures companies that any responses made during the process cannot undo any good work they have already done. And they can also correct any wrong answers later on.