European Medicines Agency to start publishing info on drug applications
Starting March 1, 2012, the European Medicines Agency will regularly publish information on applications for centralized marketing authorization for human medicines that it has received for evaluation.
The agency will publish the international non-proprietary names (INN) and therapeutic areas for all new innovative medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP), along with information on the type of salt, ester or derivative of the active substance. For generic and biosimilar medicines, it will publish the INN and therapeutic area. It will publish this information only for medicines whose applications have been validated.
The agency will update this information on a monthly basis, following the plenary meeting of the CHMP.
This initiative forms part of the drive toward increased transparency on the agency’s activities by it and other European regulatory authorities. It follows the publication of recommendations on transparency of ongoing evaluations adopted by the European Medicines Agency and the Heads of Medicines Agencies in November 2010.
The new initiative expands upon the agency's current publication of information on designated orphan medicines that are being assessed for marketing authorization in the monthly reports of the Committee for Orphan Medicinal Products (COMP). Currently, the European Medicines Agency does not publish information on other types of medicines until it has issued an opinion at the end of the assessment procedure.
This initiative also prepares for the publication of agendas and minutes of the meetings of the agency’s committees in the second half of this year.