EMA takes first steps to increase the involvement of national competent authorities in post-authorisation activities

The European Medicines Agency (EMA) has produced ground rules for extending the role of national competent authorities (NCAs) in post-authorisation procedures. Publication of the rules is in response to requests from some NCAs to extend the remit of multinational assessment team (MNAT) beyond pre-authorisation activities.

MNATs were introduced in 2012 to increase the involvement of NCAs in the work of the EMA scientific committees, as well as to optimise the use of national resources. In practice, assessment teams can therefore be formed from different NCAs. The EMA pays each NCA; the exact amount is governed by the details in their remuneration share letter.

As a result of the success of the MNAT concept pre-authorisation, the focus now has shifted towards the post-authorisation phase. The NCAs informed the EMA that they wanted to see the MNAT concept expanded to cover post-authorisation procedures. In preparation for model expansion, the EMA has published a list of ground rules and a proposed workflow for applying the MNAT concept post-authorisation. The ground rules are intended to ensure the process is flexible, permit transfer of knowledge about each medicine from pre- to post-authorisation phases and deliver an efficient and transparent payment system.

The aforementioned ground rules for the basis for a three-step workflow. EMA intend a phased introduction of the workflow. The first step, which will start this year, will be to allow existing MNAT pre-authorisation (co)rapporteurships to have the same involvement in line or indication extension applications. If this works well, the EMA will widen the post-authorisation phase to include further procedures and scenarios.

To read the EMA paper, please click here.