Third International Congress Drug Therapy in HIV Infection 3-7 November 1996 Glasgow, UK

NORTH AMERICAN/EUROPEAN PERSPECTIVES ON THE LICENSING OF DRUGS

F Rotblat
Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ

Int Cong Drug Therapy HIV 1996 Nov 3-7;3:Abstract No. 3.1
AIDS 1996, Vol. 10 (Suppl. 2);S2

Medicines for the treatment of HIV infection are licensed through the centralised procedure of the European Union (EU). This procedure was introduced in January 1995 and allows a single dossier to be submitted and a single authorisation to be granted for marketing throughout the EU. This license is administered by the European Medicines Evaluation Agency (EMEA) in London.

Authorisations for HIV drugs have usually occurred earlier in the USA, where licenses have been granted on surrogate marker data with a requirement for clinical data to be provided within a year. In Europe, clinical data have generally been required before a license is granted.

The EU has provided a discussion document on the licensing of drugs for HIV infection, and recently also considered a standard operating procedure for the licensure of drugs in exceptional circumstances.

New licenses are granted in this manner, with a number of conditions to be fulfilled by the company after the authorisation.

Regulatory concerns at present include the mechanism for licensure of different therapeutic combinations and the ability to respond speedily to new clinical studies, particularly those not carried out under company sponsorship.

Presenting author: F Rotblat

1996-11-03
3.1

Originally published in AIDS Volume 10, Supplement 2 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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