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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.

A guide to the ATMP landscape

The guidebook is the result of close collaboration with key partners, including the Dutch Medicines Evaluation Board (CBG), Hollandbio, DARE-NL, VIG, and input from over 25 experts. Building on the foundation of the VIG’s earlier guidebook, this updated and expanded edition integrates the latest insights, regulations, EMA processes, and advances in clinical research. With its practical tools and guidance, the handbook equips developers to handle complex procedures such as marketing authorization and reimbursement applications more effectively.

View the guidebook here

Patient-centered approach and collaboration

The guidebook underscores the value of early engagement with patient organizations 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.

Support and advice

Finally, the guidebook includes an overview of available support and relevant legislation. Developers are encouraged to seek advice from experts and centres of expertise, such as FAST and DARE-NL, early in the development process to simplify the path to market and minimize obstacles.

This guidebook is a valuable resource for everyone active in the rapidly growing ATMP sector, aligning with FAST’s mission to accelerate the delivery of innovative therapies to patients. In the spring of 2025, FAST, together with its partners, will host a series of webinars to present case studies and provide deeper insights into various sections of the guidebook.

De COGEM heeft een nieuwe signalering gepubliceerd, waarin zij verkent hoeveel nieuwe gentherapieën in de pijplijn zitten, wat de kosten zijn, en de dilemma’s en keuzes die met de komst van deze therapieën gepaard gaan. Ook wordt ingegaan op de instrumenten die de overheid heeft om gentherapieën betaalbaar en beschikbaar te houden.

Lees het document hier.

The Netherlands Commission on Genetic Modification (COGEM) commissions third-party research to support its work. The following project is open for enrollment: Germline modification and new gene therapies; an exploration. This project is a collaboration with the Central Committee on Research Involving Human Subjects (CCMO), and aims to gain insight into the likelihood of unintended germline modification in new (non-viral) gene therapies to support risk analysis. Interested parties are invited to submit a project bid. More information can be read here.

ZonMw, heeft, in nauwe samenwerking met het Centre for Future Affordable Sustainable Therapies development (FAST), een onderzoek geleid naar ATMP’s* in Nederland. Dit onderzoek is onderdeel van het ZonMw-deelprogramma Regulatoire Pandemische Paraatheid. Er is een overzicht gecreëerd van stakeholders, wet- en regelgeving, marktregistratie- en vergoedingsroutes, knelpunten en oplossingsrichtingen, en initiatieven omtrent de markttoegang (registratie en vergoeding) van ATMP’s.

Het rapport biedt handvatten en aanbevelingen voor ontwikkelaars, beoordelaars, beleidsmakers, zorgprofessionals en andere geïnteresseerden binnen het nationale ATMP-veld en hoopt daarmee bij te dragen aan de snelle inzetbaarheid van ATMP’s.

*ATMP’s: Advanced Therapy Medicinal Products, ook wel Geneesmiddelen voor geavanceerde therapie.

The deadline for abstract submissions for the ESGCT Annual Congress (24-27 October, Brussels, Belgium) has been extended to 30 June 2023. There will be no further extension added to this date.

Free registration is offered to student members who submit an abstract which is accepted for an oral or poster presentation. Register by 30 June to get Early Bird rates, plus reduced registration fees will apply to all ESGCT members. NVGCT members are entitled to free membership of the ESGCT for 2023, which can be requested via events@esgct.eu with proof of your NVGCT membership. This proof of NVGCT membership can be acquired via info@nvgct.nl.

FYI: Everyone who registered for this year’s NVGCT Annual Symposium (12-13 June) has automatically become a member of NVGCT.