On-going Medicine evaluation Information to be published by European Medicines Agency

pharmafile | February 24, 2012 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates 

Following the recommendations on transparency published by the European Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA), the EMA has announced that from the 1st March it will publish certain information about centralised marketing authorisation applications (MAAs) for human medicines that have been successfully validated.  Previously such information was unavailable in the public domain.  For innovative medicines, information on the name of the active substance (plus the type of salt, ester or derivative) and therapeutic area will be published.  For generics and biosimilars, the information will be limited to the name of the active substance and therapeutic area. 
 
This development may be of greatest significance to applicants for innovative medicines and orphan products, or generic companies that may be interested in gaining an awareness of applications for similar products undergoing evaluation.  To gain advice on this and other regulatory developments, please contact us on +44 (0)1628 530554 or email enquiries@wainwrightassociates.co.uk.

visit www.wainwrightassociates.co.uk

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