Publication of RMPs and their Summaries

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EMA Update: Publication of RMPs and their Summaries

7th September 2023

The European Medicines Agency (EMA) has recently announced an update regarding the publication of Risk Management Plans (RMPs) and their Summaries. This update aims to increase transparency in the safety review process for all centrally authorized products.

Key Changes (Effective 20th October 2023):

  • EMA will publish the Risk Management Plan for all centrally authorized products, including:
    • Main Body
    • Annex 4 (Specific Adverse Drug Reaction Forms)
    • Annex 6 (Details of Proposed Additional Risk Minimization Activities)
  • This applies to both initial evaluations and RMP updates.
  • RMP summaries will no longer be published.
  • A list of all historical summaries will be available on the EMA website for reference.

New Requirements for Marketing Authorization Holders (MAHs):

To protect personal and commercial confidential data, MAHs must now provide a signed declaration confirming that the RMP sent to EMA for publication via Eudralink does not contain any:

  • Personal protected data
  • Commercial confidential information

The updated template for this declaration can be found here.

Guidance on Anonymization:

EMA has published guidance on anonymizing personal data and assessing commercially identical information when preparing RMPs (Main Body and Annexes 4 and 6).