EMA Revises Guidance On Risk Management Plans To Address Industry ‘Misunderstandings’
Executive Summary
The European Medicines Agency is finalizing changes to its eagerly-awaited guidance on risk management plans, which aims to simplify the submission and maintenance of RMPs by drug companies. The EMA has fine-tuned the document to address some misunderstandings within the industry and is currently deciding on the transition plans for implementing the new requirements.