January 2026
Disclosure Roundup

Health Canada opened consultation (closes 20-Mar-2026) proposing a modernized framework: contingent authorization within seven days, 30/60-day reviews, National REB pathway, Terms and Conditions mechanism, decentralized trial provisions, emergency consent exceptions, and targeted enforcement. Two draft guidance documents have been published: a CTA guidance and GUI-0100.

The Belgian Federal Agency for Medicines and Health Products updated clinical trial application fees, effective 1 January 2026. Commercial CTA fees are: initial application EUR 4,697.61 (Phase I additional EUR 4,955.33; other phases EUR 1,738.97) and substantial modifications EUR 1,059.78. Ethics committee fees remain unchanged.

The HPRA has published updated fees for 2026. Clinical trial application fees have increased for initial applications (Codes 1001–1003), substantial amendments (Codes 1011–1017), and applications without IMPD (Codes 1007–1009). Fee exemptions for non-commercial sponsors remain unchanged. Legacy codes for substantial amendments under the Clinical Trials Directive, allowed during the transition period, have been removed.

The Pharmacy Board updated clinical trial authorization fees for 2026. Foreign-sponsored trials range from USD 1,000 to USD 7,000, depending on trial phase and sponsor type, while locally-sponsored trials range from USD 1,000 to USD 2,000, depending on product type. Protocol amendments cost USD 1,000 for both categories.

The MHRA has updated its guidance on clinical trial applications, modifications, and trial terminations under the 2025 Amendment Regulations. Updates include the combined IRAS review as standard, seven-day validation, risk-based modification categorization (Route A/B: substantial, important detail, minor), and automatic Route B approval within 14 days. Conditional approvals are enforced through inspection. Effective 28 April 2026.

The MHRA has published guidance clarifying that the principles of the Declaration of Helsinki align with the amended Clinical Trial Regulations (28 April 2026). UK law takes precedence where conflicts arise. The guidance covers placebo use, urgent safety measures, and post-trial provisions. Feedback on the draft guidance is open until 8 February 2026.

The JPMA updated its Q&A guidance on the Clinical Research Act, clarifying that implementation plan changes take effect on jRCT publication rather than CRB approval (Q17), research completion is defined as jRCT publication or MHLW submission triggering the one-year results deadline (Q19), and all specified clinical studies must register exclusively in jRCT without duplicate registrations (Q23).

HMA, CTCG, and MedEthics EU published guidance for sponsors; a one-year pilot targeting 70 calendar days from submission to Part I and Part II conclusions for eligible multinational trials. Sponsors must submit a pre-submission Expression of Interest. Capacity is limited to two trials per month. The pilot excludes mono-national trials, resubmissions, partial submissions, substantial modifications, and COMBINE trials.

The DRAP published draft amendments to the Bio-Study Rules 2017, proposing alignment with ICH-GCP and shorter approval timelines. Changes include formal GCP inspections, Drug Court enforcement mechanisms, transfer of Phase IV trial authority to the Director of Pharmacy Services, extended licence renewal windows (six months), and a longer appeals timeline (60 days). No enforcement date has been specified.

Denmark will join the EU-wide FAST-EU pilot, providing expedited assessment for eligible multinational trials via CTIS from 30 January 2026. Sponsors must submit an Expression of Interest Form in the FAST-EU Sponsor's Guide. Denmark's national expedited pathway for mono-national Phase I and integrated Phase I–II trials will continue in parallel.

The ICMJE has published updated clinical trials guidance with operational refinements. Changes include new authors' access to data requirements (Section 2), revised registration language from "requires" to "recommends" with refined timing specifying "first patient consent for enrollment", and mandatory dual registration when using non-WHO-approved registries (Section 1). The Clinical Trials Registration FAQs remain unchanged.