EU Generic Industry Group Looks At Radical Options To Simplify Pharmacovigilance Tasks
From looking at ways to reduce the number of audits undertaken by companies to fulfil their pharmacovigilance obligations to calling for harmonized assessment of risk management plans, the EU generics and biosimilars industry group Medicines for Europe says it is ready to explore some radical proposals to simplify the current pharmacovigilance requirements.
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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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