NEW EU RULES FOR ADVANCED MEDICINAL PRODUCTS IN FORCE
September 1st, 2009
BY KEITH NUTHALL
REVISED rules governing the development and manufacture within the European Union (EU) of advanced medicinal products came into force on September 14, the European Commission has announced. This new EU regulation (EC) No 668/2009 covers the evaluation and certification of quality and non-clinical data relating to such specialist pharmaceuticals made by micro, small and medium-sized enterprises. In particular, the new rules update the definitions and detailed scientific and technical requirements for gene therapy and somatic cell therapy ...
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