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 Federation of Pharmaceutical Industries and Associations has welcomed most of the changes that the European Medicines Agency has proposed making to its guideline on risk management plans (RMPs), saying that the revisions would help remove "several redundancies present in the current version" of the guidance. However, EFPIA has significant concerns over certain other parts of the revised guideline, such as the rewording of certain sections that it believes could be misinterpreted by those enforcing the guideline and create confusion.