Helping Researchers and Developers Gain Regulatory Approval for New Approach Methodologies.
ZonMw has launched the NAM Navigator: a resource base to help navigate information about the development, standardization, validation and acceptance of New Approach Methodologies.
The major challenge is that NAMs first need to be validated and then included in regulatory guidelines before widespread application can take place. It is becoming increasingly clear that animal testing is difficult to translate to human health and disease. Complex in vitro models, such as organoids and organ-on-chips, may yield better results because they are based on human cells. Such complex models, also known as NAMs, are expected to eventually replace animal testing for the safety assessment of chemical substances and the efficacy testing of pharmaceutical products.
In recent years, many NAMs have been developed, but their large-scale use by industry still lags behind. This is because the broad application of a new method requires more than just development and publication in a scientific journal. It also requires standardization and validation of the NAM, including testing the robustness and reproducibility of the underlying protocol. After that, a NAM must be accepted by regulatory authorities before it can be included in the appropriate regulatory framework. Only then can it be used by companies to assess the safety and efficacy of substances.
The NAM Navigator was developed for this purpose: its goal is to make information about the validation of NAMs for legal frameworks and regulatory guidelines easily accessible to everyone in one central location.
ZonMw hopes that the NAM Navigator can accelerate the transition to animal-free innovations and thereby reduce the number of animal experiments over time.
