Regulatory Rapporteur - TOPRA
This article aims to share some key considerations when defining the strategy for the preparation of a risk management plan (RMP). The RMP is required to be submitted when applying for an EU marketing authorisation application (MAA). Advice is offered to applicants and medicinal product developers to maximise the utility of the RMP, in both the marketing authorisation approval process and in the post-marketing setting.
The following two scenarios are described: when RMP preparation is initiated early during the product development (mostly applicable to new chemical/new biological entities, NCEs/NBEs), and when the RMP is prepared later, ie, at the time of MAA (mostly applicable to generics or hybrid applications).
Alina Tudor, Director, Vigilance Operations & EU QPPV; Julie Taccoen, Associate Director, Regulatory Science, Drugs & Biologics; Voisin Consulting Life Sciences.