PRAC reviews EMA guidance on risk management plan requirements for COVID-19 vaccines

EMA’s safety committee (PRAC) has reviewed the guidance developed by EMA for pharmaceutical companies on how to prepare risk management plans (RMPs) for COVID-19 vaccines.

As for any medicine, companies are required to submit an RMP for COVID-19 vaccines when they apply for a marketing authorisation. Such a plan explains how the company that markets the vaccine must monitor and report on its safety, and what measures they must put in place to manage any risks. Importantly, RMPs are continually updated throughout the lifetime of the vaccine as new information becomes available.

The guidance is for COVID-19 vaccines only and complements the already existing guidelines on the RMP format in the EU, which apply to all medicines.

The guidance will now be sent for adoption to EMA’s human medicines committee (CHMP) and will be made public once it is adopted by the CHMP.

Posted on the EMA website on 30 October 2020