Theme of the day of 14 September 2006

Advanced therapy medicinal products

The Committee on the Environment, Public Health and Food Safety of the European Parliament will vote today on report of Slovak MEP Miroslav Mikolášik. The report on European Commission Proposal for a Regulation on advanced therapy medical products is answering the continuing fragmentation of the European Union´s legal framework on advanced therapies and medicinal products. Miroslav Mikolášik proposes in his report an introduction of a new coherent regulatory framework for the evaluation, authorisation and supervision of advanced therapy medicinal products. The goal is thus to simplify and structuralise the market in the area, which is touching the life and health of the EU citizens.

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