EMA Guide on Development of Novel Drug Development Methodologies Released

Posted 27 January 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released a new guidance on 26 January that addresses the development of novel methodologies in drug development, and how EMA develops qualification opinions and advice for scientific methods and protocols.

The qualification process is a "new, voluntary scientific pathway leading to either a [Committee for Medicinal Products for Human Use (CHMP)] opinion or a Scientific Advice on innovative methods or drug development tools."

The process involves a CHMP qualification team issuing either a qualified opinion on the acceptability of a specific use of a proposed method based on an assessment of submitted data, or qualified advice based on a scientific rationale and preliminary data submitted to the agency. In the case of CHMP offering a qualified opinion, the process will likely involve opening the draft opinion up to public scrutiny and comment.

Costs for the advice are €75,000 for full scientific advice and €37,700 for follow-up advice. Small and Medium-sized Entities (SMEs) are entitled to 90% off the respective prices.

The guideline offers advice related to interactions with EMA, advice received from EMA, involvement with regulatory agencies, the draft procedure for the qualification process and the draft proposed format for requests.

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