Belgium has set 2028 targets for Advanced Therapy Medicinal Products (ATMP) readiness, with the Federal Agency for Medicines and Health Products (FAMHP) launching a dedicated spearhead domain to support ATMP development.
The move reflects growing political, scientific and industrial momentum to bring transformative cell, gene, and tissue therapies to patients.
“The creation of the FAMHP’s ATMP Spearhead domain was triggered by the special nature of these products, their potential to address unmet medical needs and the growing number of products under development,” Claire Beuneu, coordinator for the ATMP Spearhead at the FAMHP, told Euractiv.
“ATMP development requires regulatory flexibility and early interactions between developers and regulators,” she added.
The domain aims to provide end-to-end support for advanced therapies.
“With the creation of this new domain of expertise, the FAMHP wishes to ensure that Belgium remains at the forefront of the development of these therapies,” Beuneu said.
“Through early interactions, scientific advice, clinical trial oversight, marketing authorisations, and post-marketing surveillance, we are preparing to support the entire lifecycle of these treatments,” she explained.
Scaling capacity and engagement
Belgium intends to have a robust and scalable framework in place by 2028. The FAMHP’s first steps include building regulatory expertise through internal training, recruiting new assessors, and coordination.
“As this new spearhead domain is only starting, the first steps consist of the expansion of our regulatory capacity and expertise (…) a coordinator has been nominated,” said Beuneu.
The agency has set specific targets for the next three years: greater involvement in clinical trials and scientific advice assessment, more active participation in marketing authorisations, and improved support throughout regulatory procedures.
“With the goal of promoting the development of ATMPs, particularly in Belgium, measures will be taken to facilitate interactions with various stakeholders, including industry, academia, healthcare professionals, and patients,” Beuneu said. To support this, a multi-stakeholder platform will be created.
National commitment to clinical research
In parallel, Belgium’s 2025 new government agreement pledges to develop a national clinical trial network with a focus on ATMPs.
The political commitment aims to boost Belgium’s position as a clinical research hub and improve access to early-stage trials. This complements the FAMHP’s technical roadmap and reflects a whole-of-government approach.
The FAMHP’s five-year roadmap also prioritises deeper involvement in clinical trial assessment, scientific advice, and regulatory alignment with European standards through the EMA.
According to Beuneu, “The FAMHP will develop this domain in a collaborative approach at EU level. Our agency is an active member of the European Medicines Agency (EMA) network and will continue to work closely with European authorities to harmonise standards and best practices across Europe.”
Deloitte’s white paper Advancing Advanced Therapies echoes this vision, recommending the creation of “a centre of regulatory excellence to streamline processes” and enhance Belgium’s responsiveness to innovation.
Unlocking academic potential
As Belgium scales its systems, the role of academia is seen as crucial. “Academic institutions have a central role in the research and early development of ATMPs (…) The later stages of development, including scaling and commercialisation, are usually conducted by industry,” said Beuneu.
Beuneu explained that academia could play a bigger role through interaction with their national competent authority, collaboration with other universities or with industry and educating the next generation of professionals.
Barriers to academic translation
However, turning innovation into clinical impact remains a challenge.
According to a recent report by the Belgian Health Care Knowledge Centre (KCE) on the academic development of ATMPs in Belgium, many academic sponsors face barriers in funding, GMP access, and regulatory navigation.
Most trials remain in early phases, and the hospital exemption route is underused due to legal uncertainty and reimbursement hurdles.
Deloitte also stresses the need for accessible GMP infrastructure for academic and SME developers.
Harmonising Europe’s future framework
The upcoming revision of EU pharmaceutical legislation and the Joint Clinical Assessment under the HTA Regulation could ease access and harmonisation across member states.
“The revision of the EU pharma legislation aims to achieve ‘timely and equitable access to safe, effective, and affordable medicines’, which is certainly a challenge for ATMPs,” said Beuneu.
“Manufacturing and development of ATMPs can be a challenge in the EU, especially the conduct and approval of clinical trials for orphan indications. Harmonisation of clinical trials (via CTR) and GMO rules applying to medicinal products might help,” she remarked, adding that “FAMHP aims to ensure the streamlining of procedures… to facilitate ATMP development.”
The EU Biotech Act
The EU Biotech Act is also expected to boost competitiveness in the sector.
“The new EU Biotech Act is meant to facilitate the future development of biotechnology in Europe, including ATMPs. It should ideally identify issues to be overcome and facilitate access to the market of biotech products across all sectors by addressing bottlenecks such as financing issues, too complex frameworks (via streamlining of procedures and harmonisation throughout EU) and collaboration between EU member states, and as such support EU competitiveness in this sector,” Beuneu said.
To remain globally competitive, both the FAMHP and Deloitte stress the importance of infrastructure investment, regulatory agility, and strategic positioning.
Deloitte recommends that Belgium develop “a single brand for the Belgian advanced therapy ecosystem” to strengthen its international visibility and attract global partnerships.
[Edited by Vasiliki Angouridi, Brian Maguire]