The table below provides an overview of the timelines applied (standard or accelerated) for both mononational and multinational clinical trials, with links to websites/documents for further information.
| Mononational (only Belgium) | Multinational | |
| Standard procedure |
Substantial modifications except phase 1 (max. timelines according to CTR)1 EU Regulation clinical trials 536/2014 (Clinical Trial Regulation, CTR) |
Substantial modifications & initial dossiers: max. timelines according to CTR1 |
| Accelarated procedure |
|
FAST EU pilot initiative (intial dossiers)3 - FAST EU-Info on HMA Website (ENG) |
1 The European Clinical Trials Regulation (CTR) establishes the binding maximum timelines for the approval of clinical trial applications. These timelines are implemented and monitored through the Clinical Trials Information System (CTIS).
2 In the case of a phase I clinical trial initially submitted only in Belgium, the FAMHP already applied shorter timelines.
3 FAST-EU was launched on January 30, 2026. This is a European pilot initiative in which an accelerated assessment of multinational clinical trial submissions will be carried out by various European Member States within the framework of the CTR. The aim is to achieve an evaluation time of 70 days instead of the current 106 days. Belgium is also participating in this initiative. Each month during the test phase, several multinational clinical trials will be selected for assessment under this accelerated procedure.
4 From January 1, 2026, the FAMHP has introduced additional expedited timelines for the evaluation of initial mononational clinical trial applications concerning medicinal products for human use. The timelines are defined for Part 1 of the application. However, in the case of a full application, Part 2 will not be completed later than Part 1. This means that the expedited timelines will also be respected by the Ethics Committees, enabling faster decision-making.
Special attention is given to the initial submission of early-phase clinical trials. The timelines currently applied to mononational Phase I clinical trials will be extended to mononational Phases I, I–II, II clinical trials.
Belgium will also implement additional measures for the initial submissions of all other mononational trials (Phases II-III, III, III-IV, IV).
These new shortened timelines constitute an official national target; however, unlike the timelines for mononational Phase I trials, they are not legally defined. These timelines may be adjusted in the future based on evolving knowledge. In such cases, we will communicate transparently.
With these expedited timelines, Belgium positions itself among the fastest regulators for clinical trials in Europe, without compromising the strict requirements applicable to clinical trials. This is an incentive to strengthen Belgium’s position as a hub for clinical research.