February 2026
The HMA-EMA RWD Catalogues have introduced record completeness scores and direct EMA product page links; Egypt's EDA has launched a digital clinical trial application platform; Bhutan BFDA has replaced the DRA under the Medicines Rules and Regulation 2025, restricting trial authorization and requiring pre-submission ethics clearance; Turkey has increased Phase I–III application fees to 61,102 TL under its 2026 fee schedule; and France is implementing a fast-track clinical trial authorization pathway from 16 March 2026 for eligible mono-national Phase I or integrated Phase I/II trials.
European Union HMA-EMA RWD Catalogues New Functionalities (Feb-2026)
The HMA-EMA RWD Catalogues have introduced a record completeness score for data source entries, measuring metadata population levels. Studies related to centrally authorized medicinal products are now directly linked to their corresponding EMA product page. A completeness score for study records will also be made available.
Egypt EDA Digital Platform for Clinical Trials Launched (Feb-2026)
The Egyptian Drug Authority has launched its Digital Platform for Protocol Management and Clinical Trials, transitioning the clinical trial application submission, review and approval process to an automated digital workflow. The platform is accessible via the EDA's official website and is restricted to registered companies. This is an internal regulatory tool with no public transparency or disclosure component.
Bhutan Bhutan Medicines Rules and Regulation 2025 (21-Feb-2026)
The Bhutan Food and Drug Authority (BFDA) has replaced the Drug Regulatory Authority (DRA) under the Bhutan Medicines Rules and Regulation 2025, effective 21 February 2026. Key changes include a restriction limiting clinical trial authorization to situations of national pressing need, a mandatory pre-submission ethics clearance requirement, and the introduction of the principal investigator role.
Turkey 2026 Application Fee Schedule Published (23-Feb-2026)
The Turkish Medicines and Medical Devices Agency (T陌TCK) has published its 2026 institutional service fee schedule, updating clinical trial application fees. The initial application fee for Phase I, II, and III trials increases to 61,102 TL, low-risk scientific studies and BY/BE studies to 26,186 TL, significant change applications to 26,186 TL, and standard amendment applications to 1,091 TL.
France Fast-Track Clinical Trial Authorization Launch (23-Feb-2026)
The French National Agency for Medicines and Health Products Safety (ANSM) confirmed that the fast-track system launches 16 March 2026 for eligible mono-national Phase I or integrated Phase I/II trials. Authorization timelines are 44 days (chemical/biological drugs) and 57 days (ATMPs), reduced to 14 days where no questions are raised. The scheme is suspended annually from 15 July to 15 August and during winter clock-stop periods.
