Europe – Consideration on core requirements for RMPs of COVID19 vaccines

In addition to the EMA guidance on pharmacovigilance and vaccine development, the EMA will issue the “Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines” giving an overview of the monitoring activities to be carried out in the EU for COVID-19 vaccines, including the roles, responsibilities and interactions of the stakeholders involved. Further interactions between EMA, NCAs, and the vaccine manufacturers have identified the need to develop further guidance on RMP requirements for COVID-19 vaccines.

This guidance reflects the EMA recommendations based on current knowledge and experience. As the pandemic situation evolves and further evidence becomes available for the respective vaccine candidates, the manufacturers should take into account further guidance and experience that EMA will communicate, in the form of an updated guidance or through the scientific assessment already completed (e.g. EPARs for approved products, RMPs of approved products)…