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28 aprile 2008

Coming soon the “certification” on quality and non-clinical data of innovative medicinal products

Mauro Turrini

Date of entry into force (rectius application) of EU Regulation on advanced medicinal products such as gene therapy, somatic cell therapy, and tissue engineering is approaching (Regulation (EC) 1394/2007, so called Advanced Therapies Regulation).

The Regulation that foresees, inter alia, a certification procedure (namely, “Certification of quality and non-clinical data” also protected under art. 98.2 of the Italian Industrial Code) will allow EU Small and Medium Enterprises (SMEs) developing advanced therapy medicinal products to obtain a sort of “quality stamp” on the set of quality and non-clinical data of their products.

This certification that aim at incentiving the development of this filed and at facilitating the evaluation of any future application for clinical trials and marketing authorisation application, will enable SMEs, via a unique and relatively cheap procedure (apparently 3.000 Euros administrative fees) dealt with at the level of the European Agency of Medicines (EMEA), to profit from a new and interesting asset potentially able to attract attention of both Venture Capitalist and multinational pharmaceutical companies.

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