On 14 October 2025, the Belgian Federal Agency for Medicines and Health Products (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten / Agence federale des medicaments et des produits de santé – FAMPH) announced its intention to accelerate the evaluation of clinical trial applications concerning medicinal products for human use. By making it possible for clinical trial sponsors to commence trials more quickly, FAMHP aims to provide faster access to innovative treatments for patients and endorse the role of Belgium as a centre for clinical research within Europe.

Clinical trials limited to Belgium

From 1 January 2026, the applications for clinical trials conducted exclusively in Belgium will enjoy significantly reduced timelines. The new duration will be close to 50% shorter than the original maximum length of 60 days under the EU Clinical Trials Regulation, taking into account the validation, assessment and decision procedures (see, Articles 5-8 of Regulation (EU) No 536/2014).

This change excludes Phase I trials, which already benefit from an accelerated 20-day application process under Article 22 of the Law of 7 May 2017 on Clinical Trials of Medicinal Products for Human Use (Wet van 7 mei 2017 betreffende klinische proeven met geneesmiddelen voor menselijk gebruik / Loi du 7 mai 2017 relative aux essais cliniques de médicaments à usage humain).

The new timeline for national Phase I/II and II clinical trials will account for a 20-day assessment period. This includes five days for validation and 15 days for assessment and decision, which may collectively be extended to a maximum of 59 days should additional information be requested by FAMHP.

The new evaluation timeline for Phase II/III, III, III/IV and IV will be 35 days, accounting for seven days for validation and 28 days for assessment and decision. This will be extendable to a maximum of 79 days where additional information is requested.

Multinational clinical trials

FAMHP also announced the launch of a pilot phase to accelerate multinational Phase I, I/II and II clinical trial applications. The accelerated timeline applies when Belgium acts as reporting Member State according to the EU Clinical Trials Regulation, and is subject to the request of the sponsor and the agreement of the concerned Member States.

During this pilot phase, the initial request will be assessed in a timeline of 35 days. This may be extended to 79 days, should there be an additional information request.

Additional extension period for ATMPs and specific biotechnological products

Furthermore, FAMHP indicated that it will be possible to have an additional extension of ten days, applicable to both national and multinational clinical trial applications, for Advanced Therapy Medicinal Products (ATMPs) and specific biotechnological medicinal products.

The notice of FAMHP, which includes a summary table on the new timelines, can be found here (in Dutch) and here (in French).