FAST has collaborated with experts to create a renewed and expanded guidebook for developing Advanced Therapy Medicinal Products (ATMPs) in the Netherlands. Tailored to both academic and commercial developers, the guidebook delivers essential guidance on European and Dutch regulations and provides a roadmap to navigate the complex ATMP development process.

The guidebook underscores the value of early engagement with patient organisations and provides tools to facilitate this meaningful collaboration. It also emphasizes the importance of early engagement with stakeholders, such as the EMA, CBG, and the National Health Care Institute (ZIN). These collaborations contribute to faster patient access to ATMPs and long-term financial sustainability.

Structure of the guidebook
The guidebook is divided into three sections:

Part 1 covers key lessons and offers guidelines for patient involvement.
Part 2 provides background information and legal frameworks essential for ATMP development.
Part 3 offers a detailed overview of the entire ATMP development pathway, from preclinical research to practical implementation.