Paper: Small Companies Need Regulatory Assistance from EMA

Posted 13 March 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) needs to assist companies-particularly small businesses, academic institutions and charities-in the development of advanced-therapy medicines, claims a new paper written by members of the Committee for Advanced Therapies (CAT) in the journal Molecular Therapies.

These smaller drug development entities often lack the resources necessary to "navigate regulatory procedures," including clinical trials and application submissions.

The paper "argues that this causes a translational gap between development of these medicines and reaching later regulatory milestones, and that regulators need to continue working towards closing this gap in a proactive manner," said EMA in a statement.

EMA touted ways that it might help the entities, including giving scientific advice and other meetings.

Read more:

Molecular Therapy - Clinical Development of Advanced Therapy Medicinal Products in Europe: Evidence That Regulators Must Be Proactive

EMA - Paper calls for continued support for development of advanced therapies

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