New EU advanced medicinal products rules now in force

Published: 29-Sep-2009
Regulatory Research & Development

Revised rules governing the development and manufacture within the European Union (EU) of advanced medicinal products came into force on September 14. 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.


Revised rules governing the development and manufacture within the European Union (EU) of advanced medicinal products came into force on September 14. 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 medicinal products. They also establish technical requirements for tissue engineered products, medicines containing devices and combined advanced therapy medicinal products.

The legislation was passed by the Commission acting alone, without votes by the European Parliament and EU Council of Ministers.

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