[co-author: Eftychia Sideri]

The European Medicines Agency (“EMA”) has released a procedural guideline for rapporteurs and coordinators participating in Multinational Assessment Teams (“MNAT”).

Background

The MNAT initiative provides the option for the EMA scientific committees, including the EMA Committee for Medicinal Products for Human Use (“CHMP”) and the EMA Committee for Advanced Therapies (“CAT”), to rely on assessment teams formed from national competent authorities (“NCAs”) of different EU Member States.

Since 2013, EMA has encouraged the formation of MNATs for the assessment of initial marketing authorisation applications submitted under the centralised procedure. In 2015, EMA formalised the MNAT initiative.

With the MNAT Initiative, the EMA seeks to mobilise the best expertise for medicinal product evaluation, regardless of where experts are based.

Extension of the MNAT initiative

In 2016, the EMA agreed to extend the MNAT initiative to post-authorisation assessments. MNATs can now evaluate applications for extensions of indication and line extension applications in the post-authorisation phase.

However, the expansion of the MNAT initiative is currently limited to assessments of applications for extensions of indications and line extension applications relating to medicinal products in relation to which an MNAT was involved in evaluating the original marketing authorisation application.

The procedural guideline

a) Scientific advice procedures, initial applications for medicinal products for human use and MRL applications

The procedural guideline analyses the steps to be taken in order to put into place a MNAT:

• When submitting an offer that consists of multinational team, the (Co)-Rapporteur/Coordinator leading the multinational assessment team should inform the CHMP, or the Scientific Advice Working Party (“SAWP”) secretariats;
• If the offer is accepted, an arrangement between the lead NCA offering the (Co)-Rapporteur/Coordinator and the participating NCAs in the multinational team should be undertaken to formally agree on distribution of work, the responsibilities and the remuneration among the participating NCAs;
• The (Co)-Rapporteur should email to the EMA setting out the distribution of remuneration amongst the members of the multinational team.

The guideline provides that the lead NCA’s (Co)-Rapporteur/Coordinator retains all responsibility for the quality of the relevant assessment report. The (Co)-Rapporteur/Coordinator is also the contact point for the EMA and responsible for the communication within the multinational assessment team. In addition, EMA should inform the applicant that the (Co)-Rapporteur/Coordinator team is a multinational team.

b) Extension of indication and line extension applications

The (Co)-Rapporteur informs the EMA after the opinion on the initial application whether the MNAT will continue to apply for extension of indications and line extensions. The guideline provides that a MNAT started in the post-authorisation phase can be stopped at any time or can re-start at any time. In both cases, the (Co)-Rapporteur must notify the EMA. Furthermore, the guideline provides guidance on questions concerning the remuneration of the participating NCAs.