TPI innovation network: Advanced Therapy Medicinal Products (ATMPs)

This innovation network is concerned with assessing medicine safety.

While medicine safety assessments are subject to clear and strict rules, the legal framework is often slow to catch up when it comes to new developments. Examples of such new developments include cell therapy and gene therapy products, or Advanced Therapy Medicinal Products (ATMPs).

This partial or total absence of regulations offers an opportunity to reconsider human safety requirements from the perspective of the human body rather than the laboratory animal. This aspect constitutes the focus of the activities by the network, which launched in September 2018.

The innovation network for ATMPs involves stakeholders from the realms of government, science and industry. Its activities are carried out by the Ministry of Health, Welfare and Sport's Pharmaceuticals and Medical Technology Department. It is coordinated by RIVM. The Medicines Evaluation Board (MEB) has been engaged to supply substantive expertise.