Centralised marketing authorisation procedure: a minimum guarantee of transparency

The European Commission initially proposed that all new drug substances should be approved through the centralised procedure. However they are manufactured, new substances require strict and thorough evaluation, through a common, precisely defined and maximally transparent procedure. The current mutual recognition procedure cannot offer such guarantees: it varies from country to country and from year to year, and above all it is totally secretive.

The Forum requests clarification of recital 9, article 3 and annex I of the Regulation, which are currently vague and open to interpretation. The European Court's recent judgement on appetite suppressants, which annulled the Commission's own decisions, underlines the need for a clear regulatory framework (1,2).

The Forum requests that the Commission's initial proposal be reinstated, i.e. that all new drug substances should be approved through the centralised procedure.

National medicines agencies have nothing to fear from this centralisation. They have other important tasks on which to focus, such as inspection of facilities, pharmacovigilance, clinical trial monitoring, and evaluation of marketing applications for preparations that do not contain new substances or are reserved for the national market.

©La revue Prescrire for the Medicines in Europe Forum 1 March 2003
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1- Decision of the European Court (Second Chamber, extended composition) 26 November 2002: 47 pages.
2- Decision of the European Court 28 January 2003: 15 pages.