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) · SpainThe National Ethics Committee for Clinical Trials publishes guidance documents, annexes, and Q&A materials on clinical trial conduct and ethics.
Greece EOF · GreeceFDA proposes to substitute 'animal' with 'nonclinical' in safety and reporting regulations and align terminology with recent statutory amendments.
US Federal Register - FDA Rules · United StatesFDA substitutes 'nonclinical' for 'animal', 'preclinical', and 'in vitro' in safety and reporting regulations to align with statutory amendments and encourage alternative testing methodologies.
US Federal Register - FDA Rules · United StatesUpdated guidance on the issuance of Good Clinical Practice certificates by the Czech medicines authority.
Czechia SUKL · Czech RepublicMHRA 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 · FinlandGuidance issued on the conduct and authorisation of complex clinical trials and trials involving seasonal vaccines.
Danish Medicines Agency · DenmarkCollection 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 StatesICH M13B provides guidance on bioequivalence waivers for additional strengths of immediate-release solid oral medicines.
EMA Regulatory Guidelines · EU-wideFDA announces year five of the CMC Development and Readiness Pilot, facilitating expedited manufacturing development for IND products with accelerated clinical timelines.
US Federal Register - FDA Guidance 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 · UKCCNCE publishes version 4 (16 September 2026) of the model template for reimbursing trial participant expenses and compensation.
AIFA (Italian Medicines Agency) · ItalyUpdated Q&A guidance clarifying GLP status requirements for pivotal animal studies in clinical trial applications across all drug development stages.
Danish Medicines Agency · DenmarkFDA finalizes guidance on development of cellular and gene therapy products, addressing regulatory, manufacturing, pharmacology, clinical and pharmacokinetic questions.
US Federal Register - FDA Guidance Notices · United StatesEMA 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-wideThe 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-wideFDA requests public comment on clinical trial design elements for ibogaine drug products in opioid use disorder and PTSD studies.
US Federal Register - FDA Guidance Notices · United States