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New EU drug safety committee ends national reporting of drug reactions

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e4690 (Published 09 July 2012) Cite this as: BMJ 2012;345:e4690
  1. Rory Watson
  1. 1Brussels

The beginning of July saw the biggest change in the regulation of drugs for use in humans in the European Union since 1995, as new pharmacovigilance legislation came into force strengthening the system for monitoring the safety and benefit-risk balance of drugs.

Adopted by EU national governments and the European parliament in December 2010, the legislation created the new Pharmacovigilance Risk Assessment Committee, which will focus solely on assessment and communication of drug safety problems. It comprises national officials, independent scientific experts, and patients’ and healthcare professionals’ representatives and …

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