
EMA to open up drug evaluation process
pharmafile | February 22, 2012 | News story | Medical Communications, Sales and Marketing |Â Â CHMP, EMA, FDAÂ
The European Medicines Agency will publish ongoing drug evaluations in an effort to make its processes more transparent.
The Agency currently only publishes its conclusions on drug evaluations, but this new policy will open up the process from the day it receives a treatment for review.
From 1 March the EMA will publish the international non-proprietary names and therapeutic areas for all new medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP).
It will also publish the type of salt, ester or derivative of the active substance.
For generic and biosimilar medicines, it will publish the INN and therapeutic area, but will only publish this information for medicines whose applications have been validated.
The Agency will update this information every month following the meeting of the CHMP.
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, it added.
This new policy direction forms part of the drive towards increased transparency on its activities by the Agency and other European regulatory authorities.
The EMA has come under a lot of criticism in recent years about its closed processes, especially when compared to its US counterpart the FDA that is more transparent in how it comes to its decisions.
Ben Adams
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