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Agency to Have Greater Regulatory Power over Pharmaceutical Industry

A new law in France replaces the agency charged with the task of regulating pharmaceuticals with a new one, giving it more power and a new name. Among other new responsibilities, the Agence Nationale de Securité du Médicament will be able to fine individuals and companies and request comparative effectiveness and safety and efficacy studies before and after a drug goes to market. The new law came after the former agency was criticized for keeping a drug on the market after it had been banned in other countries when studies showed that it was harmful.

BMJ, New Law Introduces Tougher Rules on Drug Regulation in France, December 20, 2011 (subscription required).

Ministère du Travail, de l’Emploi et de la Sante, Une nouvelle politique du médicament au bénéfice des patients, December 20, 2011.

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