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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.

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