Abstract
The development and marketing of advanced therapeutic medicinal products (ATMPs) in the European Union requires a consistent yet flexible approach by all parties, including researchers, manufacturers, physicians, and regulators. A comprehensive ongoing review of the risk/benefit to the patient is necessary when dealing with these diverse and novel medicinal products and therapeutic areas, which pose numerous challenges for development and regulation of ATMPs. This article provides an overview of the EU laws, rules and guidelines to be followed for development, manufacturing and marketing authorization for ATMPs with a particular focus on cell based medicinal products (CBMPs).
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