August 2026
The EU's European Commission has published CTR Q&A v7.3, revising safety reporting and CTIS notification guidance; Australia's IGPRG has updated progress on the National One Stop Shop and its embedded registry; the UK's MHRA has launched a Phase 1 14-day assessment pilot; Ireland's HPRA has updated its CTR guide to version 5; Bosnia and Herzegovina's ALMBiH has published a new Rulebook on clinical studies, introducing portal-based submission and post-trial reporting requirements; and the US NIH has released a draft policy on sharing summary-level results with participants.
European Union CTR Q&A Version 7.3 Published (Jul-2026)
The European Commission has published version 7.3 of the Clinical Trials Regulation (EU) No 536/2014 Questions & Answers, endorsed by the CTAG. Updates concentrate on safety reporting, revising AE/SAR definitions, RSI requirements, and E2B(R3) reporting; an increased frequency of an expected SAR is now reported as a CTIS Unexpected Event rather than a SUSAR. New guidance covers ASR assessment timelines and a consolidated CTIS notification table.
Australia IGPRG Newsletter: NOSS Update and ARCS Conference Q&A (11-Aug-2026)
The Inter-Governmental Policy Reform Group (IGPRG) August newsletter includes a Q&A from the ARCS Annual Conference 2026 on the National One Stop Shop (NOSS). Following the 12-May-2026 funding announcement, NOSS will provide a single national platform with an embedded clinical trials registry and public-facing search, supporting ethics review, site authorisation, registration, reporting, and safety reporting. The appointment of a solution partner is underway, with the build anticipated to take approximately 18 months or more thereafter.
United Kingdom MHRA Phase 1 14-Day Pilot Programme Published (17-Aug-2026)
The MHRA has published guidance on a voluntary pilot reducing the first-cycle assessment target for eligible low-risk Phase 1 healthy-volunteer trials from 30 to 14 calendar days, phased across 2026 (28 days from 30-Mar-2026, stepping to 14 from 28-Dec-2026). Eligibility is restricted to defined low-risk studies, requiring advance booking within limited quarterly slots and a parallel HRA fast-track ethics review. The standard 30-day route is unchanged.
Ireland HPRA CTR Guide Updated (18-Aug-2026)
The Health Products Regulatory Authority (HPRA) has published version 5 of its Guide to Clinical Trials Conducted under the CTR in Ireland (AUT-G0170-5), superseding the June 2023 edition. Updates remove the CTD transition provisions, add Article 11 phased-submission guidance, expand to four National Research Ethics Committees, confirm non-commercial trials are fee-free, align disclosure with the revised CTIS transparency rules, and add guidance on decentralised trial elements.
Bosnia and Herzegovina New Rulebook on Clinical Studies of the Medicinal Product (24-Jul-2026)
The Agency for Medicines and Medical Devices of Bosnia and Herzegovina (ALMBiH) has published a new Rulebook on Clinical Studies of the Medicinal Product (Official Gazette 52/2026), transposing EU Regulation 536/2014 and repealing Articles 3–33 of the 2010 Ordinance. It confirms a 60-day authorisation decision, introduces portal-based submission, and requires results and lay-summary disclosure to the Agency database within one year of global trial end.
United States NIH Draft Policy on Sharing Summary Level Study Results with Participants (27-Aug-2026)
The National Institutes of Health (NIH) has released a draft policy (NOT-OD-26-113) that would require researchers to share summary-level study results in plain language with clinical research participants. It applies to all NIH-supported clinical research, not only clinical trials, regardless of funding level or mechanism. For clinical trials, results would be shared no later than one year after the primary completion date, or the ClinicalTrials.gov reporting deadline, whichever is later. The comment period closes on 26-Oct-2026.
