[co-author: Elinor Pecsteen]
Starting in April 2017, the European Medicines Agency (“EMA”) will expand the Multinational Assessment Team (“MNAT”) Initiative to post-authorisation assessments. From this date, the MNAT Initiative will allow national competent authorities not only to participate actively in the development of new medicinal products, but also to be involved in the extensions of marketing authorisations for existing medicinal products.
Background
The MNAT Initiative provides the option for the EMA scientific committees to rely, for the assessment of new marketing authorisation applications, on an assessment team formed from national competent authorities (“NCAs”) of different European Union (“EU”) Member States in return for payment by the EMA to the individual NCAs.
In practice, every new marketing authorisation for human medicinal products submitted under the centralised procedure is assessed by a rapporteur and a co-rapporteur from the EMA Committee for Medicinal Products for Human Use (“CHMP”) or the EMA Committee for Advanced Therapies (“CAT”). These scientific committees are composed of individual experts from different NCAs who must choose teams of assessors and experts to support them. Traditionally, the scientific committees choose teams of assessors and experts from their respective NCAs. The MNAT Initiative is intended to encourage the scientific committees to form multinational co-rapporteur teams with the best expertise available from a broader number of EU Member States.
The aim of the MNAT Initiative is to allow a broader involvement of NCAs from different EU Member States in the work of the EMA scientific committees. With the MNAT Initiative, the EMA seeks to optimise the use of national resources, whilst maintaining the high quality scientific work of the EMA scientific committees.
Extension of the MNAT Initiative
The MNAT Initiative started as a pilot scheme in 2013. Currently, the MNAT Initiative allows the EMA scientific committees to form multinational co-rapporteur teams for the assessment of new marketing authorisation applications submitted under the centralised procedure. The MNAT Initiative is available to:
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the EMA CHMP Committee;
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the EMA CAT Committee;
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the CHMP and CAT rapporteur teams;
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the EMA Committee for Veterinary Medicinal Products (“CVMP”);
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the Scientific Advice Working Party.
The MNAT Initiative is open to all members of the European medicines regulatory network, which is composed of the NCAs of all Member States of the European Economic Area (“EEA”). Apparently in 2016, NCAs from all but two of the 31 EEA countries have been involved in the initial evaluation of human medicines, as rapporteur, co-rapporteur or an assessor in an MNAT.
On 19 December 2016, the EMA Management Board endorsed the EMA document entitled “Multinational assessment team concept: the next phase – Broadening the concept to the post-authorisation phase”. This document provides that, from April 2017 assessment teams consisting of different EU Member States NCAs will also be able to evaluate applications for extensions of marketing authorisations of existing medicinal products.
The expansion of the MNAT Initiative will initially be limited to assessments of applications for extensions of indications and line extension applications, relating to products in relation to which an MNAT was involved in evaluating the original marketing authorisation application.
Building up capacity and capability in light of Brexit
Brexit raises the need for the EMA to find solutions and ways to reduce the Agency’s reliance on United Kingdom experts and, once the UK leaves, to compensate the loss of UK expertise.
The EMA reportedly views the MNAT Initiative as a means of compensating for the expected Brexit-related loss of UK expertise from the European medicines regulatory network.
For more information visit: https://pink.pharmamedtechbi.com/PS119981/EMAs-Multinational-Approach-Brings-All-But-Two-Member-States-Into-New-Drug-Assessor-Fold
