How can we regulate medicines better?

doi:10.1136/bmj.39281.615706.94

BMJ 2007;335:803-805 (20 October), doi:10.1136/bmj.39281.615706.94

Feature

How can we regulate medicines better?

Silvio Garattini, director, Vittorio Bertele', head of the regulatory policies laboratory

Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milano, Italy

Correspondence to: S Garattini garattini@marionegri.it

Current European licensing regulations give precedence to theinterests of drug companies. Silvio Garattini and Vittorio Bertele'suggest changes to ensure they meet the needs of patients anddoctors

The first 150 words of the full text of this article appear below.

Despite the undoubted advantages of the establishment of theEuropean Medicines Agency (EMEA)^w1 criticisms have been made,mostly about its independence and transparency and the evaluationcriteria.¹ ² ³ The 2004 European Commission law expanded the agency's remit but did not significantly changesthe methods of regulation.^w2 We offer a few proposals aimedat bettering the work of the agency. These may require importantchanges in current law regulating the pharmaceutical system.

The agency gives opinions on the quality, safety, and efficacyof new drugs that manufacturers want to market in the EuropeanUnion. The European Commission uses the agency's opinions todecide whether to grant a licence.

Unlike the US Food and Drug Administration, the European agencyis not autonomous but an expression of the national agenciesin the European Union, which approve most new products. Evaluationthrough the centralised procedure has become mandatory for biotechnologyproducts and drugs for HIV, . . . [Full text of this article]

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