Consideration on Core Requirements for Risk Management Plans of COVID-19 Vaccines —CoreRMP19 Guidance

On 13 November 2020 the EMA issued the new guidance on risk management plans (RMPs) for COVID-19 vaccines.

The guidance reflects special safety monitoring measures for COVID-19 vaccines by providing considerations and requirements for several sections of the RMP.

EMA will publish the full body of the RMP (plus Annex 4) for all authorized COVID-19 vaccines, in line with its exceptional transparency measures for COVID-19 medicines.

This coreRMP19 document addresses the planning for post-marketing surveillance for COVID-19 vaccines in the context of marketing authorization in the EU.

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