EMA Releases Revised Guidelines for Risk Management Plans

June 8, 2016

The European Medicines Agency is offering drugmakers new advice on when to update risk management plans for products with centralized marketing authorization.

The updated document applies to products that require revisions to their existing RMPs as well as older products that were approved prior to the EU mandating RMPs for all marketing authorizations in 2012.

Drugmakers are required to submit new or revised RMPs during a product’s lifecycle or post-authorization stage in the following cases:

  • A significant change in indication such as, disease area, age group or severity;
  • A new dosage;
  • A new route of administration;
  • A new manufacturing process;
  • Changes in a product’s benefit-risk profile;
  • Final study data that has a “consequential impact” on the RMP; and
  • Application renewal or in cases where there are changes to product information.

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