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ATMPs in the EU: Overcoming Regulatory Hurdles

Advanced therapy medicinal products (ATMPs) comprise a new category of innovative therapies to treat genetic diseases effectively. ATMPs are split into three categories: somatic cell therapy medicinal products (SCTMPs), gene therapy medicinal products (GTMPs), and tissue-engineered products (TEPs). Some ATMPs may contain one or more medical devices as an integral part of the product (combined ATMPs) (1).

Within the EU, these therapies are regulated as biological products. As of October 2021, 13 ATMPs have been approved by the EMA, and are being commercialised (see Figure 1). Among these are adeno-associated virus (AAV)-based gene therapies (e.g., voretigene neparvovec), CAR T (e.g., tisagenlecleucel and axicabtagene ciloleucel), and stem cell-based therapies, such as modified CD34+ haematopoietic stem cells.

Despite these approvals, the path to successful market authorisation can be challenging, requiring extensive and complex preclinical and clinical studies. ATMP development is typically faced with hurdles in three main areas: scientific, technical, and regulatory (2). A case-by-case approach is required for the first two, while regulatory challenges generally span all types of ATMPs.

Sergio Lainez Vicente and Jaleel Shujath at Absorption Systems (October 2021)

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