Advanced Therapeutic Medicinal Products (ATMPs) represent a dynamic and evolving field of medical progression, with a rapid growth in product diversity. This holistic classification of drug products covers a range of cell and gene therapies and delves into the world of medical devices. Regulations, product manufacturing processes and product classification, amongst other key drug development procedures, are a real challenge in the ATMP landscape and pose a steep learning curve to all those involved, from preclinical development through to market authorisation. The development of ATMPs is far more complex than traditional drug development and therefore it is vital to have the right scientific and regulatory expertise early on, as well as a tailored development plan to increase the chances of a successful outcome.
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