30 August 2023

Understanding Risk Management Plans in Pharmaceutical Development

A significant aspect of ensuring the safety and efficacy of pharmaceutical products is the submission and management of Risk Management Plans (RMPs) to the European Medicines Agency by pharmaceutical companies seeking marketing authorization for their products.


RMPs are not static documents; they’re continually reviewed, changed, and updated throughout a product’s lifecycle. Updates occur for numerous reasons, such as the reception of new data that could activate tremendous adjustments to the advantage-hazard profile or reaching critical pharmacovigilance or chance-minimization milestones. Regulatory bodies like EMA and National Competent Authorities (NCAs) keep the authority to request an RMP at diverse degrees.


To increase transparency, the EMA has revised the publication of the RMP. Effective October 20, 2023, EMA publishes RMPs (main body and annexes 4 and 6) for all centrally authorized products, including preliminary and updated assessments. However, RMP summaries will no longer be published. This initiative aims to provide greater visibility into the safety inspection process for centrally authorized products.


RMPs can only be submitted at the same time as the periodic safety update report (PSUR) if the change in the RMP comes as a consequence of the PSUR. The RMP or RMP summary is available on each medicine page. Alternatively, a historical list of all RMP summaries is available.


For more details about RMPs and the process of anonymizing personal data (PD) and evaluating commercially confidential information (CCI) while creating RMPs, refer to the document Guidance on the anonymization of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6).