Regulations for advanced therapy (ATMPs)

There are strong regulations to test the safety of medicines. This often takes place through mandatory animal testing. No such regulations have yet been formulated for Advanced Therapy Medicinal Products (ATMPs). These comprise medicines for cell therapy and gene therapy, for instance. This presents opportunities for animal-free safety tests.

Human tests instead of animal tests

The safety requirements for ATMPs are intended to guarantee safety for humans. It thus does not make sense to test them for safety on animals. The opportunities to develop ATMPs without using animal testing differ per product. The National Institute for Public Health and the Environment (RIVM) and the Medicines Evaluation Board (CBG, College ter Beoordeling van Geneesmiddelen) are drafting a plan for this. This will then be presented to international experts. Eventually, this should lead to animal-free regulations as issued by the European Medicines Agency (EMA).