ABSTRACT

Advanced therapy medicinal products (ATMPs) are a rapidly developing class of innovative therapies that use living cells, tissues, or genes to treat or prevent diseases. The EU has a specific regulatory framework for ATMPs, which is designed to ensure the safety and efficacy of these products while also facilitating their development and access to patients. The EU ATMP regulation (Regulation (EC) No 1394/2007) establishes a multidisciplinary Committee for Advanced Therapies (CAT) to assess the quality, safety, and efficacy of ATMPs. The EU ATMP regulation also provides for a number of different regulatory pathways for ATMPs, depending on the product's characteristics and the target patient population. These pathways can be used to accelerate the development and approval of ATMPs, while still ensuring the safety and efficacy of these products. This abstract delves into the landscape of regulatory considerations surrounding ATMPs in the EU. It highlights the current Regulatory framework, approval pathways for marketing authorisation, European Medicines Agency (EMA) and its Committee for Advanced Therapies (CAT) evaluation process. The abstract navigates through the diverse regulatory pathways available for ATMPs, from clinical trials to market authorization. It underscores the synergy between innovation and patient welfare by exploring the priority medicines (PRIME) scheme introduced by the EMA. By examining the dynamic interplay between evolving scientific advancements and regulatory vigilance, this abstractilluminates the strategic maneuvers and collaborative efforts driving the regulatory considerations shaping the future of ATMPs in the EU. Keywords: Committee for Advanced Therapies, Certification, Evaluation, PRIME, Regulatory framework
Publication date: 01/09/2024

https://ijbpas.com/pdf/2024/September/MS_IJBPAS_2024_8342.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.9.8342