The National Authority for Health (Haute Autorité de Santé, HAS) published the updated Early access to medicines: laboratory support guide (Accès précoce des médicaments : accompagnement des laboratoires – guide) on 25 March 2026. This technical update – which functions as an evolution of the doctrine established in 2021 – refines the requirements for the presumption of innovation and the clinical evidence needed for market entry. It introduces a more rigorous framework for the pre-submission phase to manage the increasing volume of requests.
The revised guide establishes strict criteria for attendance at pre-submission meetings – known as rencontres précoces. The regulator will now only grant these meetings if the applicant provides substantial new clinical data and plans to submit a formal application within three months. These measures prevent companies from using consultative resources for products that are not yet ready for evaluation. This ensures that the technical dialogue focuses on the maturity of the evidence base.
These changes respond to a recent trend of increasing rejection rates for early access requests. Many previous applications failed to meet the required standards for clinical data and innovation. By clarifying the expected data quality, the authority aims to ensure that manufacturers supply more robust evidence. This strategy is designed to increase the proportion of approved requests among the dossiers that enter the formal assessment window.
The measures apply to all new applications from 1 April 2026. The shift toward higher evidentiary standards aligns the national process with the European Union Joint Clinical Assessment (JCA) framework. Manufacturers must now demonstrate how their data packages meet both national and European clinical criteria. These updates will likely result in a more efficient approval process for high-quality dossiers.
Source: Haute Autorité de Santé
Link: Accès précoce des médicaments : accompagnement des laboratoires – guide (Early access to medicines: laboratory support guide)
Date: 25 March 2026
