EMA issues guidance on risk-based approach for advanced therapies

EMA logoThe European Medicines Agency (EMA) has adopted guidance on the use of a risk-based approach to the development of advanced therapy medicinal products (ATMPs), in line with the revision of Annex 1, part IV of Directive 2001/83/EC as amended by Directive 2009/120/EC. Advanced therapies include gene therapy (GTMPs), somatic cell therapy (sCTMPs), tissue engineering products (TEPs) and combinations.

The guidance outlines a methodology of identifying risks and risk factors associated with the clinical use of the ATMP, to identify the relationships between them (including clinical studies, if necessary) and determining whether the provided scientific data and/or published information addressing the individual risk factor-risk combinations are considered adequate and sufficient to support an Marketing Authorisation Application (MAA).

The guidance explains the consequences of this risk-based approach for the MAA dossier, and presents fictitious examples for each class of advanced therapy.

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