Clinical trials regulation sets the rules for how human research is authorised, conducted, and reported. In the EU the Clinical Trials Regulation (EU) No 536/2014 harmonised assessment through the Clinical Trials Information System, replacing the earlier directive. Good Clinical Practice, ethics committee review, safety reporting, and transparency obligations all apply. This page collects the updates HealthSignal tracks on trial authorisation, CTIS, guidance and inspections, and national requirements across Europe and the US, from official public sources only.
FDA announces final ICH guidance on harmonized digital clinical trial protocol standards, templates, and technical specifications for international regulatory exchange.
US Federal Register - FDA Guidance Notices · United StatesEC Public Health publishes general principles governing AI use in preparing Joint Clinical Assessment dossiers.
EC Public Health · EU-wideMHRA guidance on the approval process and criteria for clinical investigations of medical devices.
UK MHRA · UKGuidance on investigator obligations and requirements for clinical investigations of medical devices under MHRA regulation.
UK MHRA · UKFDA CDER requests feedback on developing a cross-sector collaborative platform to advance quantitative medicine approaches in drug development and regulatory science.
US Federal Register - FDA Notices · United StatesParliamentary amendments to draft legislation establishing a framework for strengthening EU biotechnology and biomanufacturing, amending food, ATMP, clinical trials, veterinary, and related regulations.
European Parliament - SANT Subcommittee (Public Health) · EU-wideParliamentary amendments to draft legislation establishing a framework for strengthening EU biotechnology and biomanufacturing, amending food, ATMP, clinical trials, veterinary, and related regulations.
European Parliament - SANT Subcommittee (Public Health) · EU-wideGuidance on how to notify the MHRA of a planned clinical investigation of a medical device.
UK MHRA · UKFimea has published a Finnish-language translation of Good Clinical Practice guidance.
Finland Fimea · FinlandFDA finalizes ICH M15 guidance on model-informed drug development planning, evaluation, documentation, and regulatory submission.
US Federal Register - FDA Guidance Notices · United StatesUpdated guidance on methodology and procedure for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideFimea will continue to offer targeted guidance to clinical trial researchers on CTIS (Clinical Trials Information System) use as needs arise.
Finland Fimea · FinlandGuidance on information requirements for notifying the MHRA of clinical investigation plans for electrically powered devices.
UK MHRA · UKGuidance on conducting biological safety evaluation required before undertaking clinical investigations for medical devices.
UK MHRA · UKGuidance on statistical data requirements for clinical investigations of medical devices.
UK MHRA · UKGuidance on transitional arrangements for the Clinical Trials Regulations.
UK MHRA · UKFDA finalizes guidance on clinical trial design and conduct for psychedelic drug development in psychiatric and substance use disorder treatment.
US Federal Register - FDA Guidance Notices · United StatesGuidance on submitting applications for clinical trials that include an in vitro diagnostic device.
UK MHRA · UKACT EU initiative identifies regulatory and operational bottlenecks for non-commercial clinical trial sponsors and establishes support measures including a helpdesk for CTIS navigation and regulatory guidance.
ACT EU - Accelerating Clinical Trials · EU-wideGuidance clarifying methodological and procedural requirements for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideFDA revises draft guidance on design, analysis and regulatory submission of master protocol trials for drug and biological product development.
US Federal Register - FDA Guidance Notices · United StatesGuidance on how to join the MHRA's phase I accreditation scheme for clinical trials of medicines.
UK MHRA · UKFDA revises draft guidance on clinical evidence standards for drug effectiveness, clarifying reliance on one adequate and well-controlled investigation with confirmatory evidence.
US Federal Register - FDA Guidance Notices · United StatesGuidance on clinical trial record retention and archiving requirements covering ownership, data integrity, and transitional provisions.
UK MHRA · UKFDA finalizes guidance on selecting laboratory values as cancer trial eligibility criteria to avoid unjustified participant exclusions.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on washout periods and concomitant medication exclusions in cancer clinical trial eligibility criteria.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance recommending expansion of cancer clinical trial eligibility criteria to include patients with wider range of performance status.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on statistical methods for bioequivalence studies in drug applications, replacing 2001 guidance.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on applying quantitative systems pharmacology modeling to determine starting doses in first-in-human trials for drugs and biologics.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on leveraging prior knowledge in development of human gene therapy products with ex vivo and in vivo genome editing.
US Federal Register - FDA Guidance Notices · United StatesHHS seeks public input on safe harbor and exception modifications for remuneration to clinical trial participants under anti-kickback and beneficiary inducement rules.
US Federal Register - HHS Rules · United StatesClarifies which regulatory guidelines apply to the development of phage therapeutic products in the UK.
UK MHRA · UKTwo pilot initiatives launched to coordinate scientific advice between clinical trial approval and design, and pre-clinical trial application regulatory advice, continuing into 2026.
ACT EU - Accelerating Clinical Trials · EU-wideGuidance documents supporting the Clinical Trials Regulation, which governs investigational medicinal product trials in the EU.
EC Clinical Trials · EU-wideGuidance on clinical trial record retention and archiving requirements including ownership, data integrity, and transitional provisions.
UK MHRA · UKGuidance clarifying how amended UK clinical trial legislation aligns with the Declaration of Helsinki, with UK law taking precedence in conflicts.
UK MHRA · UKInformation relating to good clinical practice (GCP) inspections.
UK MHRA · UKGuidance on procedures for collecting, verifying and reporting safety events in investigational medicinal product trials.
UK MHRA · UKGuidance on implementation and enforcement of ICH E6(R3) good clinical practice principles in UK clinical trial legislation.
UK MHRA · UKGuidance on how ICH E6(R3) good clinical practice principles are implemented and enforced under UK clinical trial legislation.
UK MHRA · UKGuidance on compliance with ICH E6(R3) good clinical practice standards for clinical trials conducted in the UK.
UK MHRA · UKGuidance identifying common validation and assessment issues in clinical trial applications and how to avoid them.
UK MHRA · UKMHRA guidance on alignment of amended UK clinical trial legislation with the Declaration of Helsinki, with UK law taking precedence in conflicts.
UK MHRA · UKGuidance on expanded enforcement provisions, offences, and compliance requirements for sponsors and investigators under Clinical Trials Regulations.
UK MHRA · UKGuidance on how to apply for clinical trial authorisation in the UK, covering eligibility, phases, documentation and application amendments.
UK MHRA · UKGuidance on transitional arrangements for applying for clinical trial approval under the new regulations.
UK MHRA · UKGuidance on procedures for collecting, verifying, and reporting safety events in investigational medicinal product trials.
UK MHRA · UKGuidance on how to apply for clinical trial approval in the UK from 28 April 2026, covering eligibility, phases, costs and application changes.
UK MHRA · UKFDA draft guidance on streamlined nonclinical toxicology study approaches for oncology biologics and conjugated products to reduce animal use.
US Federal Register - FDA Guidance Notices · United StatesNew streamlined Combined Review process for clinical trials with single application, 100-day maximum review timeline, and mandatory trial registration and results publication.
UK Health Research Authority · UK