Companies Use Revised EU Risk Management Plan Template Ahead Of Mandatory Deadline
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.
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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.
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.
A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.