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Published on 22 October 2007

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Pharmacologists in call for EMEA reform

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The EMEA needs to transform the way it operates in order to ensure it meets the needs of both patients and doctors, according to a report.

The claims were made in an article in the British Medical Journal by Silvio Garattini and Vittorio Bertele from Italy’s Mario Negri Institute for Pharmacological Research.

They claim the organisation currently only requires pharmaceutical firms to show that their new drugs are equivalent to current treatments before they are approved.

They believe this policy favours drug companies, and are calling for the regulations to be revamped in order to ensure new drugs have some added value over current treatments – or are cheaper.

They also call for more transparency in the way the EMEA operates. They claim that unlike the FDA, the EMEA keeps almost all of its information secret.

Yet the investigators believe there is no reason to be secretive about toxicological and clinical reports.

They also want the EMEA to release details of the size of the majority that approves a given drug, and the reasons why approvals are opposed and rejected.

They say: “Some of our suggestions will make the approval of new drugs and new indications more difficult and prolong the time needed for their introduction.”

But they add: “We believe the changes will not only be important for patients but will help stimulate innovative research by drug companies.”

Copyright © PA Business 2007

BMJ



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