Regulatory information - Management of changes to risk management plans and certain quality aspects simplified

New post-authorisation guidance is published today

The European Medicines Agency (EMA) has published today new guidance on the procedural management of risk management plans (RMP) submissions and on the classification of changes to the marketing authorisation post authorisation. Both guidance documents introduce simplified procedures for marketing authorisation holders.

The new RMP guidance provides all relevant information on the classification of RMP changes (e.g. how RMP changes are classified, which changes can be included in an RMP update without the need for an additional variation) as well as procedural aspects of the RMP lifecycle (e.g. how to present RMP updates, how to handle parallel RMP submissions). In addition, the guidance simplifies the management of complex RMP updates: some RMP changes currently submitted as groupings (type IIs/IBs or IBs/IBs variations) will now be accepted as a single variation.

The second guidance document provides advice to marketing authorisation holders on the classification of changes to the marketing authorisation post authorisation and for certain variation classification categories. The guidance includes a simplified approach for the handling of quality-related changes due to the introduction of a new manufacturing site for a finished product.