CMDh Updates SOP for PSUR Single Assessment Procedures

The Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) has released a Standard Operating Procedure (SOP) for handling Periodic Safety Update Report (PSUR) single assessment procedures for nationally authorised products in the EU.

Key Points:

• Legal Framework: Defines roles and responsibilities within the PSUR assessment process.
• Submission & Evaluation: Includes timelines, procedure management, and Lead Member State selection.
• Assessment Process: Standardized report format, decision-making criteria, and regulatory actions.
• Implementation & Monitoring: Ensures CMDh consensus positions and European Commission decisions are followed across Member States.
• The SOP streamlines PSUR assessments, enhancing safety monitoring and regulatory consistency.

Region: European Union