The Pharmaceutical Journal
Vol 268 No 7186 p233-237
23 February 2002

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Medicines Control Agency (www.mca.gov.uk)

Europe proposes regulatory reform

Proposals for significant reform to the European system for licensing medicines have been brought forward by the European Commission.

The proposals will require more products to go through the centralised licensing procedure and will lead to the automatic revocation of licenses if products are not marketed.

Currently, the centralised procedure is only compulsory for biotechnology products. The proposal will make it compulsory for all new active substances. Marketing authorisations will no longer need to be renewed every five years; instead products will be subject to periodic safety updates at given intervals. In addition, marketing authorisations will be cancelled if products are not brought to market within two years of approval or two years after a withdrawal.

There will also be annual licensing for medicines that are considered to be of great benefit to patients and a fast-track authorisation procedure for highly innovative drugs or products with a major impact on public health.

The proposals are outlined in MLX282, published by the Medicines Control Agency on 13 February. Comments can be sent to Michael Darbyshire, 2001 Review Consultation, Room 16-102, Market Towers, 1 Nine Elms Lane, London SW8 5NQ (tel 020 7273 0928, e-mail 2001Review@mca.gov.uk) until 10 May 2002.

MLX282 is available from the MCA website (www.mca.gov.uk).