Companies Use Revised EU Risk Management Plan Template Ahead Of Mandatory Deadline

10 Aug 2017

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.

Hands — Companies are voluntarily using the Revised EU risk management plan template • Source: Shutterstock

Some pharmaceutical companies have begun reaping the benefits of the revised EU template for preparing their risk management plans (RMPs) by voluntarily using it in their submissions.

The use of the revised template – whose purpose is to facilitate a more fit-for-purpose RMP, focused on minimizing, mitigating...