合规倒计时：应对英国新要求

Countdown to Compliance: NewUKClinical Trial TransparencyRequirements Contents Overview of the new requirements3Dealing with deferrals5Assigning accountability6Choosing registries6Sharing results7Operationalizing transparency8Audience Q&A9Roadmap and ongoing compliance12 Countdown to Compliance: NewUKClinical Trial TransparencyRequirements Overview of the new requirements On 28 April 2026, the UK’sMedicines forHuman Use Clinical Trials Amendmentregulations come into force, and trial represented key stakeholder perspectivesacross policy, registry operations, and industrypractice. registration, results publication, and participantsummaries will become legal requirements.A recent Citeline-sponsored webinar for theRegulatory Affairs Professional Society (RAPS),“Countdown to Compliance: New UK ClinicalTrial Transparency Requirements,” broughttogether an expert panel covering the practicalsteps that sponsors, registries, and CROs needto take to meet those requirements. The panel The panelists focused on five themes: what’schanging; why it matters; how registrationworks in practice; what’s required for results,publication, and participant summaries; howthe deferrals and waivers framework operates;and how organizations can build sustainableongoing compliance. What, When, Where, and Why: Overview WHAT to Register WHEN to Disclose WHERE to Register •AllCTIMPsacrossall phases(I–IV)submitted on/afterApril 28, 2026– includingdrugs, biologics, vaccines,gene therapies, and celltherapies•Interventional trials only– observational and non-interventional studiesexemptfrom statutory requirements(though registration remainsgood practice)•Full protocol registrationrequired (design, population,interventions, endpoints)– minimal records onlypermittedduring approveddeferral periods Critical deadline, theearlierof: Public Registry– Sponsorsmust register in a qualifyingWHO ICTRP primary or partnerregistry, or data provider, thatfacilitates public access to UKtrial information;CTIS does notmeet this requirement •Before first participantrecruitment, OR•Within 90 days of approval Example scenario: •Trial approved July 1, 2026;first participant recruitedSept. 15, 2026 –Register bySept. 14, 2026•Trial approved July 1, 2026;recruitment delayed –Register by Sept. 29, 2026(90 days) •ISRCTN– Example of aqualifying registry; HRAencourages use – allows laysummaries, plain languageresults, minimal recordsfor deferrals; HRA auto-registration for CombinedReview•ClinicalTrials.gov– Exampleof a qualifying registry;recommended where an FDArequirement exists •Offencefor failure to register or publish results•MHRA graduated enforcement approach: infringement notices – prosecution (last resort)•MHRA may consider sponsor’s compliance history across multiple trials Countdown to Compliance: NewUKClinical Trial TransparencyRequirements “Registration becomes a statutory obligation,” explainedmoderator Ben Evans, “triggered by the earliest of firstparticipant recruitment or 90 days from approval. Resultsmust be published within 12 months of trial conclusionin every public registry where the trial was registered.Sponsors must also offer plain language summariesto participants for all new-rules trials,” said Evans,Manager, Clinical Trial Disclosure Regulations, Citeline.“Additionally, for the first time, failure to register orpublish results becomes an offense, for ongoing trialsthat are unregistered as of 28 April 2026, and for resultsof trials concluding on or after that date, regardless ofwhen they were submitted.” He said the UK’s Medicinesand Healthcare products Regulatory Agency (MHRA) hasindicated a graduated enforcement approach. Ben Evans Manager, Clinical TrialDisclosure Regulations, Citeline Evans also noted that the participant summary obligationdoes not extend to transitional trials; it applies only tothose submitted on or after 28 April 2026. “And a keytransitional deadline to flag,” he noted, “is the 27th of July,2026, 90 days from implementation, which is the backstopby which all unregistered ongoing trials must be registered.” Amy JointProgramme Manager, ISRCTNRegistry, BMC Clive Collett, Head of Policy & Engagement at the UK’sHealth Research Authority (HRA), added: “For a trialapproved on the 1st of July, 2026, the 90-day backstop ison the 29th of September 2026. But if the first participant isrecruited on, say, the 15th of September 2026, registrationmust precede that date.” He further clarified the new requirements: “Studies wouldneed to be registered within 90 days of approval or beforethe recruitment of the first participant, whichever is thesoonest. So there is a change there that currently it is withinsix weeks of recruitment, but that will shift for clinical trialsof medicines to before the recruitment of the participant.There will not be that sort of six-week period to register. …So those are the main changes.” Dr. Kate DarwinVP of Regulatory Affairs,Quotient Sciences Collett also recommended that sponsors