This module examines the regulatory requirements for ATMPs in the EU and compares them with other territories, e.g. the US, EU, UK and Japan. It considers the scientific principles underpinning the development and regulation of ATMPs and the complexities involved.
It covers the legislation, classification and certification, and the importance of having a clear classification early in the regulatory process and borderlines between different types of ATMPs. It also includes GMP and GCP; issues specifically relating to ATMPs and other relevant legislation that must be considered, such as requirements for blood derivatives.