Briefing on AI use in protein, peptide and nucleic acid design across biopharmaceutical research, industrial biotechnology and vaccine development, with regulatory implications for the EU.
European Parliament - SANT Subcommittee (Public Health) · EU-wideGuidance on how to notify the MHRA of intention to carry out a clinical investigation for medical devices.
UK MHRA · UKMHRA guidance on the approval process and criteria for clinical investigations of medical devices.
UK MHRA · UKFDA 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 StatesGuidance on investigator obligations and requirements for clinical investigations of medical devices under MHRA regulation.
UK MHRA · UKFDA will begin rejecting pharmaceutical and biologics submissions failing new eCTD v3.2.2 and v4.0 validation criteria effective 2024–2025.
US Federal Register - FDA Guidance Notices · United StatesFDA announces support for forward compatibility of eCTD Version 4.0 for electronic submissions to CDER and CBER.
US Federal Register - FDA Guidance Notices · United StatesEMA announces the pilot procedure for clinical trial application consultation under the ACT EU initiative becomes permanent from January 2027.
Lithuania VVKT · LithuaniaBelgium introduces synchronised procedure guidance for combined clinical trials with medicinal products and device performance or clinical investigations.
FAMHP (Belgian Medicine Agency) · BelgiumGuidance on how to notify the MHRA of a planned clinical investigation of a medical device.
UK MHRA · UKEC Public Health publishes general principles governing AI use in preparing Joint Clinical Assessment dossiers.
EC Public Health · EU-wideFDA 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 StatesGuidance 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 · UKEMA and HMA invite comments on updated EU-IN guidance describing scientific and regulatory support tools available nationally and at EU level for medicine and technology development.
AEMPS (Spanish Medicine Agency) · SpainMHRA will deliver first-wave regulatory assessment of qualifying Phase 1 trial applications within 14 calendar days by end of 2026.
UK MHRA · UKAmendment to Swedish regulations exempting genetic testing from licensing requirements when conducted as part of general health screening programmes.
Socialstyrelsen - Föreskrifter (SE) · SwedenFDA announces draft guidance on designing, validating and evaluating potency assays for active immunotherapy products including peptide and protein-based ACTIMPs.
US Federal Register - FDA Guidance Notices · United StatesFimea will continue to offer targeted guidance to clinical trial researchers on CTIS (Clinical Trials Information System) use as needs arise.
Finland Fimea · FinlandCollection of joint clinical assessment reports, procedural guidance for joint scientific consultations on devices and IVDs, and methodological Q&As for HTA dossier preparation.
EU HTA Regulation Implementation · EU-wideFDA 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-wideACT 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-wideCTIS safety module launches 28 September 2026 for annual safety report (ASR) submission by clinical trial sponsors.
Latvia ZVA (State Agency of Medicines) · LatviaGuidance clarifying methodological and procedural requirements for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideMHRA pilot programme to deliver first-wave regulatory assessment of qualifying Phase 1 applications within 14 calendar days by end of 2026.
UK MHRA · UKPublication of guidance for sponsors on safety reporting procedures in combined clinical trials.
EC Public Health · EU-wideGuidance on clinical trial record retention and archiving requirements covering ownership, data integrity, and transitional provisions.
UK MHRA · UKHHS solicits input on regulatory pathways for deceased donor islet cell therapies for Type 1 diabetes treatment.
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-wideFimea has published a Finnish-language translation of Good Clinical Practice guidance.
Finland Fimea · FinlandNew guidance documents published to support sponsors implementing the Clinical Trials Regulation, addressing frequent assessment issues and decentralised trial elements.
ACT EU - Accelerating Clinical Trials · EU-wideGuidance on submitting applications for clinical trials that include an in vitro diagnostic device.
UK MHRA · UKThe Accelerating Clinical Trials in the EU advice pilot, coordinated by HMA, becomes a permanent initiative from January 2027 to support sponsors in preparing clinical trial applications.
EMA - European Medicines Agency · EU-wideEMA launched a voluntary data submission pilot to facilitate sharing of data generated using New Approach Methodologies as alternatives to animal testing.
EMA - European Medicines Agency · EU-wideClarifies which regulatory guidelines apply to the development of phage therapeutic products in the UK.
UK MHRA · UKNew 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 · UKThe Clinical Trials Information System safety module go-live has been postponed; details available in the Clinical Trials Newsletter.
Danish Medicines Agency · DenmarkIQWiG and LSE researchers discuss the first Joint Clinical Assessment under the EU HTA Regulation and its implications for evidence generation.
IQWiG (German HTA) · GermanyA new Safety Module in CTIS will launch on 28 September 2026, with a two-month transition period ending 30 November 2026.
Danish Medicines Agency · DenmarkPublic consultation on amendments to GMP guidelines for pharmaceutical manufacturing, including Chapter 4, Annex 11, and a new Annex 22.
EC Clinical Trials · EU-wide19 Oct 2026 Clinical Trials Information System (CTIS) sponsor end user training programme - October 2026 Online European Medicines Agency, Amsterdam, the Netherlands Start date: 19 October 2026, 09:00 (CEST) End date:...
EMA - European Medicines Agency · EU-wideNewThis Walk-in clinic on CTIS functionalities provides an opportunity for sponsors to receive practical information about the Clinical Trials Information System by asking CTIS experts questions in advance.
EMA - European Medicines Agency · EU-wideA study by INFARMED and EMA experts analyzes the evolution of medicinal product clinical trials in the EU/EEA between 2013 and 2025 using CTIS and EudraCT data.
Portugal INFARMED · PortugalThe Confidentiality Advisory Group (CAG) has published its Annual Report for 2025-26, highlighting a successful year supporting research and other activities that use patient information to improve health and care. CA...
UK Health Research Authority · UKAn intensive week-long mission in Vilnius was held to build Ukraine's capacity in clinical trial evaluation as part of an EU twinning programme.
Lithuania VVKT · LithuaniaAIFA launches training courses on Organ-on-Chip and RNA Therapeutics for regulatory experts.
AIFA (Italian Medicines Agency) · ItalyEU-wide call for participation in COMBINE pilot coordinated assessment programme; expressions of interest open until 31 August 2025.
ACT EU - Accelerating Clinical Trials · EU-wide