EMA Revises Guidance on Advanced Therapies

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European Medicines Agency clarifies advanced-therapy medicinal products classification.

The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) has revised itsDraft Reflection Paper On Classification Of Advanced-Therapy Medicinal Products (ATMPs) to clarify which drugs may be classified as ATMPs (i.e., innovative drugs made from tissues, genes, or cells). The paper also takes a look at borderline cases and evolving scientific knowledge.

The paper clarifies what constitutes a substantial manipulation of cells or tissues, defines non-homologous use of cells or tissues, clarifies when drugs based on recombinant viral vectors are considered as vaccines against infectious disease and not as gene-therapy medicinal products, and sets criteria for combined ATMP classification.

An ATMP classification offers incentives such as fee reductions and is usually the first connection between EMA and ATMP developers. According to the agency, it can help sponsors identify applicable regulatory framework for their drug development path.


The paper is open for public consultation until Oct. 31, 2014.

Source: EMA