At the time of authorisation, information on safety is relatively limited due to the numbers exposed during clinical studies and the limited patient population studied. The product will have a positive benefit:risk for a specific population in a specific indication at time of approval. There will be multiple risks with varying severity at the time of approval which will be further characterised and new risks identified post-authorisation with wider use.
It is necessary to focus on pharmacovigilance activities that are needed to define the safety profile further with focus on specific issues from pre and post-authorisation data and pharmacological principles. This also allows for appropriate risk minimisation or mitigation strategies to be identified and implemented.
Essjay Solutions has had extensive experience with RMPs and specifically with older products where an RMP is now required. This has challenges in itself as very often the data required to complete the new EU template is not available.