April 2026
Disclosure Roundup

The PMRA has updated clinical trial authorization fees under the Pharmacy and Medicines Regulatory Authority (Fees and Forms) (Amendment) Regulations, 2026, effective 01-Apr-2026. Phase-based application fees range from USD 5,000 to USD 9,000, with a reduced rate of USD 2,000 for academic research trials. Amendment, renewal, and fast-track fees are also specified.

SAHPRA has published a new guideline (SAHPGL-CEM-CT_12_v1) outlining the pre-clinical testing and clinical requirements for Phase I and First-in-Human studies, effective 01-Jun-2026. The guideline covers dose selection, safety monitoring, stopping rules, sponsor responsibilities, facility requirements, and ethics oversight by RECs and the NHREC.

The HMA confirmed that 23 applications were received in the latest FAST-EU submission window, with four accepted for evaluation; Reporting Member States for this cycle are Belgium, Norway, Spain, and the Czech Republic. The next submission window is scheduled for 22–23 April 2026, with applicants invited to confirm preferred CTIS submission weeks in advance.

The HRA has published a blog outlining new legal transparency requirements under SI 2025/538, effective 28 April 2026. Sponsors will be legally required to register trials before first consent and publish results within 12 months of trial end. Transitional arrangements apply to ongoing trials, with a registration deadline of 27 July 2026. Non-compliance may result in MHRA enforcement action.

The Icelandic Medicines Agency has published a revised fee schedule (No. 350/2026), effective immediately, superseding No. 287/2026. CTA application fees now distinguish Iceland's role as supervising (RMS: ISK 1,499,400) or participating country (CMS: ISK 994,500). A new annual report assessment fee (ISK 46,000) has been introduced. Substantial amendment fees increase to ISK 183,600.

The FDA sent messages to over 2,200 companies and researchers associated with more than 3,000 registered trials regarding apparent failures to submit required results to ClinicalTrials.gov or complete NLM quality control review. Communications seek voluntary compliance ahead of potential Pre-Notices and Notices of Noncompliance.

The HRA has launched the Modification Tool via IRAS, replacing the Amendment Tool ahead of SI 2025/538 coming into force on 28 April 2026. The tool reflects updated terminology and introduces four modification categories: substantial modification of an important detail, minor, and non-notifiable. Full functionality, including PDF generation, becomes available from 28 April 2026.

ISRCTN has launched a prototype Results Reporting System to support compliance with updated UK clinical trials regulations, which came into force on 28 April 2026. Sponsors are now required to publish a results summary within 12 months of study completion and offer participants a plain-language summary. The production system will include online validation, dynamic tables, and helpdesk support.

The EMA published version 2.2 of the CTIS Transparency Guidance, Annex I, and Quick Guide. The update confirms that translations of patient-facing documents are not subject to publication, as they are submitted under Part II (data protection), per CTCG Best Practice guidance. References to the prior standalone Q&A (EMA/898965/2022) have been replaced throughout with the Sponsor FAQs.

From 01-May-2026, ethics committees have enrolled in Swissmedic's fast-track pilot for category B and C trials. Sponsors with written confirmation of fast-track eligibility from Swissmedic must include this when submitting to BASEC, triggering priority review. The pilot was initiated by Swissmedic in July 2025 and reduces Swissmedic processing times to 20 days (standard) and 40 days (first-in-human).