December 2025
Regulatory agency updates for December 2025 include ISRCTN's application form guidance with Rapid Registration Checklist; Slovakia ŠÚKL's beta website launch with H2 2026 full transition; Romania's national platform for real-time CTIS data in Romanian; and Austria BASG's increased fee schedule effective Jan. 1, 2026.
ISRCTN Application Form Guidelines (Dec. 1, 2025)
The ISRCTN published application form guidance following enhancements to its website. The guidance explains the data fields required for study registration. It covers five sections: Study Overview, Information for Participants, Contacts/Sponsor/Funder/Ethics, Uploads/Outputs, and Payment. Additionally, a Rapid Registration Checklist is provided to expedite the submission process.
Slovakia ŠÚKL Website Modernization (Dec. 1, 2025)
The State Institute for Drug Control (ŠÚKL) launched a trial version of its website at beta.sukl.sk to improve user experience, modernize design, and enhance accessibility. Full transition from the current www.sukl.sk to the new platform is planned for the second half of 2026.
Romania National Clinical Trials Platform Launch (Dec. 10, 2025)
The National Agency for Medicines and Medical Devices (NAMMDR) has launched a national platform (https://studiiclinice.anm.ro/) that provides real-time access to CTIS data in Romanian, classified by therapeutic areas and geographical distribution. The platform serves as an informational and educational tool for patients, physicians, and the medical community to identify ongoing clinical trials in Romania.
Austria Clinical Trial Fee Schedule Increased (Dec. 15, 2025)
The Federal Office for Safety in Health Care (BASG) implemented a revised clinical trial fee schedule effective Jan. 1, 2026. Phase I–III fee notification increased to €4,081, Phase IV to €2,052, and substantial modifications to €679. Under the EU CTR (Regulation 536/2014), BASG assessment fees now range €1,392–€6,074, Ethics Committee fees €821–€4,112, and substantial modification fees €569–€1,076 (BASG) and €886 (Ethics Committee).
