FAST, in collaboration with experts, has developed a renewed and expanded handbook for the development of Advanced Therapy Medicinal Products (ATMPs) in the Netherlands. These therapies — including gene therapies, cell therapies, and tissue engineering products — have the unique potential to achieve lifelong effects through one-time or short-term treatments. This handbook provides essential insights into European and Dutch legislation and regulations concerning ATMPs and offers practical guidance for successfully navigating the key steps in the development process.

Guide to the ATMP landscape

FAST, in collaboration with CBG, HollandBIO, DARE-NL, VIG, and more than 25 consulted experts, has revised and expanded a handbook originally developed by VIG. The updated guide incorporates the latest insights, regulations, EMA procedures, and developments in clinical research. The focus is on streamlining the pathway from scientific innovation to patient care, offering practical recommendations to overcome technical and regulatory hurdles.

Patiënt-centered approach and collaboration

The handbook emphasizes that early collaboration between developers and patient organizations is crucial, and it provides practical guidance for fostering such partnerships. It also highlights the importance of early engagement with key stakeholders, including the EMA, CBG, and the Dutch National Health Care Institute (ZIN). This proactive approach aims to accelerate patient access to ATMPs and to support sustainable financing models.

A catalyst for innovation

With this guide, FAST aims to create a more efficient and accessible process for ATMP development in the Netherlands. It offers researchers and developers concrete tools to bring innovative therapies to patients with complex and rare conditions.

The full report is available via the FAST website.

In 2025, FAST will also host a webinar series covering the topics from the handbook.