COVID-19: EMA accelerates its Regulatory Process

The European Medicines Agency has published an overview of how it will accelerate its regulatory procedures so that the marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures will be able to accelerate every step of a medicine’s regulatory pathway.

Faster support in the R&D phase

Scientific Advice: In the context of COVID-19, fees for scientific advice are waived and the procedure is reduced to a maximum of 20 days, compared to normally 40-70 days.

PIPs and compliance checks: The total review time for a paediatric investigation plan (PIP) for COVID-19 products will be reduced to 20 days, compared to normally up to 120 days active review time. In case needed, EMA also carries out a check to ensure companies comply with the agreed measures listed in each PIP before a marketing authorisation can be submitted, which will now also be reduced to 4 days.

EUCOPE welcomes these changes intending to fast-track the development and approval of medicines and vaccines.