From 1 January 2026, the FAMHP will introduce accelerated timelines for the assessment of initial clinical trial applications concerning medicinal products for human use. This measure ensures that clinical research can start faster, to the benefit of the patient, and strengthens Belgium's top position as a centre for clinical trials.
Faster assessment of mononational clinical trials
From 1 January 2026, initial applications for mononational phase I, phase I/II and phase II clinical trials will be assessed within a maximum of 20 days of submission. In case of requests for additional information during the assessment, the maximum time limit is 59 days. For advanced therapy medicinal products (ATMPs) and certain biotechnological medicinal products, this deadline can be extended by 10 days. Taking into account the winter clock stop, these measures will take effect after 7 January 2026.
For mononational phase II/III, phase III, phase III/IV and phase IV clinical trials, the maximum assessment period is 35 days, or 79 days in case of a request for additional information. Again, there is a 10-day extension for ATMPs.
The new, accelerated timelines cover both Part I and Part II and are about half as short as before. For phase I trials, timelines were already in place. With these accelerated timelines, the FAMHP is positioning itself among the fastest regulators in Europe without compromising the strict requirements for clinical trials.
Pilot phase for multinational clinical trials
In addition, the FAMHP is launching a pilot phase for the accelerated assessment of multinational phase I, phase I/II and phase II clinical trials when Belgium acts as reference member state. These accelerated timelines are applicable upon request by the sponsor and after agreement by the member states concerned. Initial applications will be assessed within a maximum of 35 days from submission, or 79 days in case of a request for additional information (with a possible 10-day extension for ATMPs and certain biotechnological medicinal products).
If, in the future, European pilot phases are launched in which we can participate, and these also significantly accelerate the assessment of the submission of a multinational clinical trial, the multinational pilot phase as described above will be terminated. The FAMHP, together with the College and the Ethics Committees, strives for harmonisation in Europe. By focusing on cooperation between member states, better and more sustainable results can be achieved.
A step forward for patients and for Belgium
With this extension, the FAMHP significantly accelerates the processing of applications for mononational clinical trials and takes the initiative to apply this principle to multinational trials as well. This ensures that innovative treatments can be investigated more quickly for patients, without compromising on quality or safety. The strong cooperation between the FAMHP, CT College, Barec and the Ethics Committees makes this possible.
This measure again underlines the FAMHP's role as an efficient and reliable partner within the European clinical trial landscape and confirms Belgium's top position as a centre of clinical research.
Summary of accelerated timelines
|
Type of clinical trial |
Validation |
Evaluation and decision |
Extension for ATMPs and certain biotechnological medicinal products |
|
Mononational - Phase I, Phase I/II, Phase II |
5 days |
15 days |
+10 days |
|
Mononational - Phase II/III, Phase III, Phase III/IV, Phase IV |
7 days |
28 days |
+10 days |
|
Multinational (pilot phase) - Phase I, Phase I/II, Phase II |
7 days |
28 days |
+10 days |