EMA Fast-Tracks Development, Support and Approval of COVID-19 Medicines and Vaccines

The rapid procedures described in the inventory can accelerate every step of a medicine’s regulatory pathway and the agency is fully mobilized to deliver these fast-track assessments in the shortest possible timeframes while ensuring robust scientific opinions are reached. These ‘rapid’ procedures stem from the EMA’s emerging health threats plan. The flexible and fast review of medicines is supported by the EMA’s pandemic Task Force (COVID-ETF), which brings together in one group the best scientific experts from the EU regulatory network. It will work closely with the EMA’s human medicines committee (CHMP) for optimal and fast coordination of activities related to the development, authorization and safety monitoring of medicines and vaccines against COVID-19.

For products under development, in early stages and/or before the submission of a marketing authorization application, the EMA has established accelerated mechanisms which will require developers to submit well-prepared dossiers to the agency. Depending on the maturity of the development, initial discussions on the various mechanisms to fast-track development and approval will take place, with priority given to the most relevant proposals. According to the EU pharmaceutical legislation, the standard timeline for the evaluation of a medicine is a maximum of 210 active days. However, applications for marketing authorization for COVID-19 products will be treated in an expedited manner. The various rapid procedures are also available in the context of extensions of indications for already approved medicines, which are being repurposed in the fight against COVID-19.

“Supporting the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines as soon as possible is one of EMA’s top priorities in the COVID-19 public health emergency. Together with our scientific committees and working parties, we have adapted our procedures in order to significantly shorten our own regulatory timelines for the review of new medicines and vaccines against COVID-19,” said Executive Director Guido Rasi. “However, the rapid approval of therapeutics and vaccines will only be possible if applications are supported by robust and sound scientific evidence that allows EMA to conclude on a positive benefit-risk balance for these products.”

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European Medicines Agency