On 14 October 2025, the Belgian Federal Agency for Medicines and Health Products (FAMHP/FAGG) announced a major overhaul of its clinical trial evaluation timelines. The reform, which enters into force on 1 January 2026, is designed to significantly accelerate the approval of clinical trials for medicinal products intended for human use. With this move, Belgium aims to reinforce its position as one of Europe’s most competitive and innovation-friendly destinations for clinical research. Faster authorisation processes not only benefit sponsors but also enable earlier patient access to promising therapies.
Belgium’s decision comes at a time when competition between EU Member States for clinical research investment continues to intensify. Predictable timelines, transparent procedures and regulatory agility are becoming critical differentiators for sponsors selecting countries for Phase I to Phase IV studies. By shortening approval windows and simplifying coordination, Belgium is sending a clear message: the country intends to remain at the forefront of pharmaceutical innovation.
Shortened Timelines for Mononational Clinical Trials
A central element of the reform is the introduction of significantly reduced evaluation timelines for clinical trials conducted exclusively in Belgium. Under the EU Clinical Trials Regulation(CTR), the standard maximum duration for validation, assessment and decision-making is 60 days. Starting in 2026, this will change dramatically for most phases of development.
Phase I Studies
Phase I trials, which are already subject to an accelerated review process under Belgian law, will not be altered. These studies continue to follow the 20-day timeline established in Article 22 of the Law of 7 May 2017. However, all subsequent phases, ranging from Phase I/II toPhase IV, will benefit from substantially shorter review periods.
Early-Phase Trials
For early-phase trials such as Phase I/II and Phase II, the new Belgian timeline will amount to a total of 20 days, combining five days for validation and fifteen days for assessment and decision. In practice, this means that sponsors may begin their clinical activities in less than three weeks from submission, provided no additional information is requested. If the FAMHP requires clarification or supplementary data, the timeline may extend to a maximum of 59 days. Developers of Advanced Therapy Medicinal Products (ATMPs) or certain biotechnological medicines should be aware that an additional ten-day extension may apply to ensure sufficient regulatory scrutiny of these highly specialised investigational products.
Later-Phase Trials
Later-phase trials, including Phase II/III, Phase III, Phase III/IV and Phase IV studies, will also experience considerable acceleration. The new deadlines set the total review period at 35 days, 7 days for validation followed by 28 days for evaluation and decision-making. If the agency poses further questions, the overall timeline may be extended, but even in that case, the maximum duration remains significantly shorter than what sponsors are used to under the standard CTR framework.
Together, these changes represent one of the most ambitious national accelerations of clinical trial timelines within the European Union. For biotech and pharmaceutical companies working within tight development schedules, the reform provides a powerful incentive to prioritise Belgium as a location for future clinical studies.
Accelerated Procedures forMultinational Clinical Trials
The FAMHP’s ambitions do not stop at national studies. Belgium also announced the launch of a pilot phase to accelerate multinational clinical trial applications when Belgium acts as the Reporting Member State (RMS) under the CTR. This pilot applies to Phase I, I/II and II trials and is activated upon the sponsor’s request, with the additional condition that all involved Member States agree to the shortened procedure.
During the pilot, initial assessment will take place within 35 days. As with national procedures, an additional information request may extend the timeline to a maximum of 79 days. By offering these accelerated pathways, Belgium aims to increase its attractiveness as RMS, a role that significantly shapes the overall speed, coordination and quality of multinational clinical trial authorisations. For sponsors, working with an efficient RMS can influence not only timelines but also the likelihood of smooth cross-country alignment.
Belgium Joins the FAST-EU Initiative
In parallel with national changes, Belgium will actively participate in FAST-EU (Facilitating and Accelerating StrategicTrials), an EU-level initiative designed to harmonise and accelerate the authorisation of multinational clinical trials across the EU/EEA. FAST-EU aims to streamline interactions between national medicines agencies, enhance coordination with Ethics Committees, and introduce more predictable and ambitious timelines.
This initiative is expected to strengthen Europe’s competitive capacity in attracting high-priority clinical research, particularly for strategically important therapeutic areas. Operational details will be communicated by the Heads of Medicines Agencies ahead of the programme’s launch at the end of January 2026. For sponsors planning large multinational trials, FAST-EU may significantly reshape planning assumptions for 2026 and beyond.
What This Means for Sponsors
Overall, the 2026 reform marks a decisive shift in Belgium’s regulatory landscape. By accelerating the review of clinical trial applications, both nationally and within the context of EU collaboration, the FAMHP is creating an environment with greater predictability, reduced startup delays and improved alignment with sponsor expectations. These changes will likely translate into faster patient access, more efficient resource allocation and a strengthened positioning of Belgium as a leading European destination for early development trials, ATMP studies and complex multinational programmes.
For sponsors navigating tightening global development timelines, the message is clear: Belgium is preparing to offer one of the fastest and most innovation-friendly regulatory environments in Europe.
