EMA Proposes Significant Changes To Guidance On Risk Management Plans And Template
This article was originally published in SRA
The European Medicines Agency has proposed significant changes to its pharmacovigilance guideline on risk management plans to further clarify how drug companies should address identified or potential risks of a drug and tackle "missing information" about a product in an RMP. Also, major changes have been proposed to the integrated RMP template1,2.
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Some companies have been quick to take up the revised EU template for preparing their risk management plan (RMP) submissions well ahead of the mandatory deadline. A marketing authorization application for an advanced therapy medicinal product – which made use of the new RMP template – has already received a positive opinion from the European Medicines Agency.
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.
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.