Category
Clinical Trials
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.
Regulation
Category
Impact
Date
PMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – July 2026
23 Jul 2026 PMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – July 2026 Online Start date: 23 July 2026, 09:30 (CEST) End date: 23 July 2026, 10:30 (CEST)
EMA - European Medicines AgencyAMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.953v01-00
AMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...
European Parliament - SANT Subcommittee (Public Health)AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.939v01-00
AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...
European Parliament - SANT Subcommittee (Public Health)Clinical trials for medicines: Clinical Trials Regulations transitional arrangements
Guidance on transitional arrangements for the Clinical Trials Regulations.
UK MHRAPsychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Psychedelic Drugs: Considerations for Clinical Investigations." Because interest in the therapeu...
US Federal Register - FDA Guidance NoticesQuestions and answers (version 22) - Safety features for medicinal products for human use
News announcement 10 July 2026 Questions and answers (version 22) - Safety features for medicinal products for human use 1 min read
EC Public HealthNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), ...
US Federal Register - FDA RulesResearch: MHRA data requirements to support regulatory decision making
A regulator’s view on what the new UK Health Data Research Service must deliver.
UK MHRAEudralex Volume 4: Reference and Retention Samples (revised, applicable as of 24 September 2026)
News announcement 24 June 2026 Eudralex Volume 4: Reference and Retention Samples (revised, applicable as of 24 September 2026) 1 min read
EC Pharmaceutical StrategyQuantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biol...
US Federal Register - FDA Guidance NoticesMaster Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological Product Development." This draft guidance revises and...
US Federal Register - FDA Guidance NoticesMedicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP
This request for information seeks input from the public on whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute or the exceptions to the civil monet...
US Federal Register - HHS RulesResearch: National Commission into the Regulation of AI in Healthcare: research, engagement and call for evidence findings
Findings from the National Commission into the Regulation of AI in Healthcare's call for evidence and wider research and engagement activities.
UK MHRANew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction
The Food and Drug Administration (FDA or we) is amending the final rule that published in the Federal Register of April 16, 2026. That final rule updated regulations to reflect application-related actions for new anim...
US Federal Register - FDA RulesLeveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Edit...
US Federal Register - FDA Guidance NoticesOncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Co...
US Federal Register - FDA Guidance NoticesStatistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence." This guidance provides recommendations...
US Federal Register - FDA Guidance NoticesM11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)." The guidance was prepared u...
US Federal Register - FDA Guidance NoticesACT EU workplan for 2026-2027 & updated objectives published
News article 8 May 2026 ACT EU workplan for 2026-2027 & updated objectives published 1 min read
ACT EU - Accelerating Clinical TrialsGuidance: Clinical trials for medicines: Archiving and retention of clinical trial records
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
UK MHRAClinical trials for medicines: non-investigational medicinal products
Guidance on using non-investigational medicinal products in a clinical trial.
UK MHRAGuidance: Clinical trials for medicines: Declaration of Helsinki and Clinical Trial Regulations alignment
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
UK MHRAGuidance: Clinical trials for medicines: Notification of Serious Breaches of GCP or the trial protocol
Information on practical arrangements for notification, what should and should not be classified as a “serious breach” and what must be reported.
UK MHRAGuidance: Formulating responses to GCP inspection findings
How to respond to the GCP inspection report findings, increase awareness of the GCP Inspectors’ expectations and aid formulation of an acceptable response.
UK MHRAClinical trials for medicines: Good clinical practice inspections
Information relating to good clinical practice (GCP) inspections.
UK MHRAClinical trials for medicines: collection, verification and reporting of safety events
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
UK MHRAClinical trials for medicines: Compliance with ICH E6 good clinical practice (GCP) in the United Kingdom
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
UK MHRAGuidance: Clinical trials for medicines: roles and responsibilities
Which professions can act as an investigator, training and experience expectations, provision of medical support and delegation of activities.
UK MHRAGuidance: Clinical investigations: investigators' responsibilities
How to make sure your clinical investigation will meet the MHRA's requirements for medical devices.
UK MHRAClinical trials for medicines: guidance on quality and risk proportionality
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
UK MHRAClinical trials for medicines: guidance on compliance with ICH E6 good clinical practice (GCP) in the United Kingdom
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
UK MHRAClinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products
Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials.
UK MHRAConsultation of new guidance on the conduct of clinical trials during public health emergencies in the EU
News announcement 5 March 2026 Consultation of new guidance on the conduct of clinical trials during public health emergencies in the EU Consultation of new guidance on the conduct of clinical trials during public hea...
EC Public HealthNew guidance on the conduct of clinical trials during public health emergencies in the EU
News article 5 March 2026 New guidance on the conduct of clinical trials during public health emergencies in the EU 1 min read
ACT EU - Accelerating Clinical TrialsResearch: Review of the impact of recommendations for the prescribing of isotretinoin
Public Assessment Report on the review of the implementation of the recommendations of the Commission on Human Medicines Isotretinoin Expert Working Group and Isotretinoin Implementation Advisory Expert Working Group.
UK MHRAPatients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation
The MHRA is now setting out the next phase of reforms for 2026, aimed at helping patients access new cutting-edge treatments more quickly and boosting the UK’s competitiveness for global clinical research.
UK MHRAGuidance: Archiving and retention of clinical trial records
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
UK MHRAGuidance: International Council for Harmonisation (ICH) E6R3 Annotations
Information to help comply with ICH E6(R3), if you are running clinical trials in the UK.
UK MHRAGuidance: Common issues identified during clinical trial applications
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
UK MHRAGuidance: Clinical Trials Regulations enforcement provisions
Information about Clinical Trials Regulations outlining expanded enforcement provisions, offences, and compliance requirements for sponsors and investigators.
UK MHRAGuidance: Declaration of Helsinki and Clinical Trial Regulations alignment
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
UK MHRAImproved scientific advice for medicines for public health threats including antimicrobial resistance
News article 17 November 2025 Improved scientific advice for medicines for public health threats including antimicrobial resistance 1 min read
ACT EU - Accelerating Clinical TrialsNew and updated documents - EudraLex Volume 10: Clinical trials guidelines
News announcement 30 October 2025 New and updated documents - EudraLex Volume 10: Clinical trials guidelines New and updated documents - EudraLex Volume 10: Clinical trials guidelines 1 min read
EC Public HealthResearch: Report of The Commission on Human Medicines Isotretinoin Implementation Advisory Expert Working Group
Report of Isotretinoin Implementation Advisory Expert Working Group regarding recommendations to strengthen the safe use of isotretinoin, the acne medicine commonly known by brand names Roaccutane and Reticutan.
UK MHRAPresentations and recording - Prevention Matters: Advancing Research and Policy with Human-Centered Approaches (16 October 2025)
News announcement 17 October 2025 Presentations and recording - Prevention Matters: Advancing Research and Policy with Human-Centered Approaches (16 October 2025) Presentations and recording - Prevention Matters: Adva...
EC Public HealthUK clinical trial approval times twice as fast with AI and reforms
Patients receive earlier access to life-saving treatments as UK trial approval times cut in half from 91 to just 41 days.
UK MHRASir David Spiegelhalter: Regulation in an age of personalised medicine
The internationally renowned expert in the calculation and communication of risk and statistics, Sir David Spiegelhalter, discusses the concept of a ‘preference zone’ to frame the demands of safety, efficacy and choic...
UK MHRAGuidance: Clinical trials that include an in vitro diagnostic device
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device
UK MHRA
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