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Published on 20 February 2012

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EMA to publish drug applications from March

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The European Medicines Agency will publish information on drug applications for centralised marketing authorisation of human medicines from March.

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.

The INN and therapeutic area for generic and biosimilar medicines will also be published if the application is validated.

Updates will be published each month after the plenary meeting of the CHMP.

The initiative is in response to calls for increased transparency by European regulatory authorities and follows the adoption of guidelines on transparency by the EMA in November 2010.

This expands upon the Agency’s current publication of information on designated orphan medicines that are being assessed for marketing authorisation in the monthly reports of the Committee for Orphan Medicinal Products (COMP). Currently, the 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.



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