July 2026
The Netherlands' CCMO has published its 2027 fee schedule, raising CTA and substantial modification fees under Regulation 536/2014; the UK's MHRA has clarified how results-publication details are submitted at end of trial and the HRA has issued RES SOPs Version 8.1 reflecting the 2025 Amendment Regulations; and Canada's Health Canada has finalized its registration and results disclosure guidance, introducing a new results deferral, and launched a Clinical Trial Search Portal.
Netherlands CCMO 2027 Clinical Trial Fee Schedule Published (30-Jun-2026)
The Central Committee on Research Involving Human Subjects (CCMO) has published its 2027 fees for medical-ethical review of clinical trials under Regulation (EU) 536/2014, applying from 1 January 2027. CTA fees rise to EUR 8,340 (Netherlands as RMS) and EUR 5,550 (as a concerned Member State), with reduced non-commercial rates of EUR 2,780 and EUR 1,850. Substantial modification fees range from EUR 660 to EUR 2,610.
United Kingdom MHRA End-of-Trial Guidance Updated (15-Jul-2026)
The MHRA has updated its guidance on ending a clinical trial, clarifying the route for submitting details of where results have been published. For combined-review trials, these details are provided to the licensing authority and ethics committee via IRAS; for trials approved through separate applications, they are emailed to [email protected]. The underlying registration and results-publication obligations under the amended Clinical Trials Regulations are unchanged.
United Kingdom RES SOPs Version 8.1 Published (16-Jun-2026)
The Health Research Authority has published Version 8.1 of the Research Ethics Committee Standard Operating Procedures, effective 16 June 2026, reflecting operational implementation of the Medicines for Human Use (Clinical Trial) (Amendment) Regulations 2025. Updates cover combined MHRA/REC review, revised timelines, the notifiable trial authorization pathway, modification categories, and transparency requirements under Regulation 25, applying retrospectively to ongoing trials.
Canada Registration and Results Disclosure Guidance Finalized (29-Jul-2026)
Health Canada has finalized its guidance on the registration of clinical trials and public disclosure of results, superseding the 2023 draft. Registration is expected no later than 21 calendar days after first participant enrolment, with summary results within 12 months of primary study completion. A new deferral permits results posting until the earlier of 30 days after a market authorization decision/withdrawal or 36 months post-completion. The guidance remains non-binding policy.
Canada Canadian Clinical Trial Search Portal Launched (29-Jul-2026)
Health Canada has launched the Canadian Clinical Trial Search Portal, replacing the 2013 Clinical Trials Database. The bilingual portal is a search tool, not a registry, publishing selected fields for Phase I–III drug trials authorized since 01-Apr-2013, sourced from Health Canada systems, WHO-compliant registries, and the WHO ICTRP, with links to full registry records. Comparative bioavailability studies, single-patient trials, and Phase IV trials within approved conditions are excluded.
