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-wideMHRA guidance on the use of real-world data and real-world evidence in regulatory decision-making for medicines and medical devices.
UK MHRA · UKFact sheet outlining regulatory changes to medicines and medical devices legislation in the Health Bill.
UK DHSC Policy Papers & Consultations · UKFDA announces support for forward compatibility of eCTD Version 4.0 for electronic submissions to CDER and CBER.
US Federal Register - FDA Guidance Notices · United StatesFDA 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 StatesA national programme to drive healthcare advancements and accelerate patient access to innovation and new treatments.
UK MHRA · UKMHRA and RIO invite stakeholder input on artificial intelligence use in medicines development and safety.
UK MHRA · UKUpdated guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway.
Swissmedic · SwitzerlandDEA establishes Special Registration framework for telemedicine practitioners to prescribe controlled substances without in-person evaluation, with heightened recordkeeping and reporting requirements.
US Federal Register - DEA Telehealth Rules · United StatesImpact assessment framework for proposed Medicines and Healthcare products Regulatory Agency reforms under the Health Bill.
UK DHSC Policy Papers & Consultations · 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 StatesDEA finalizes rules preventing illegal distribution of controlled substances via internet, including telehealth prescribing restrictions and identity verification requirements.
US Federal Register - DEA Telehealth Rules · United StatesDEA issues interim rule amending regulations to implement the Ryan Haight Act's provisions preventing illegal distribution of controlled substances via the Internet.
US Federal Register - DEA Telehealth Rules · United StatesEMA 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) · SpainDEA and HHS postponed the effective dates of final rules expanding buprenorphine telemedicine treatment and VA continuity-of-care telemedicine from March 21 to a later date pending further review.
US Federal Register - DEA Telehealth Rules · United StatesDEA and HHS delayed the effective date of two final rules on buprenorphine telemedicine and VA continuity of care from February 18 to March 21, 2025.
US Federal Register - DEA Telehealth Rules · United StatesDEA and HHS amend regulations to permit audio-only telemedicine prescribing of schedule III-V controlled substances for opioid use disorder after PDMP review.
US Federal Register - DEA Telehealth Rules · United StatesDEA extends temporary exceptions allowing telemedicine prescribing of controlled medications without prior in-person evaluation beyond November 11, 2023.
US Federal Register - DEA Telehealth Rules · United StatesDEA extends temporary exceptions to controlled-medication prescribing rules to permit telemedicine without prior in-person evaluation pending final rulemaking.
US Federal Register - DEA Telehealth Rules · United StatesDEA proposes rule permitting telehealth prescribing of controlled medications without prior in-person evaluation in limited circumstances.
US Federal Register - DEA Telehealth Rules · United StatesThe 13th edition of the Swiss Pharmacopoeia entered publication in October 2026, with entry into force scheduled approximately 6 months later, including new monographs for quantified liquorice root fluid extract and Lugol's solutions 1-5%.
Swissmedic · SwitzerlandSwissmedic announces adaptations to requirements for establishment licences and GMP certificates for active substance manufacturers, effective 1 October 2026.
Swissmedic · SwitzerlandFDA 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 StatesFDA draft guidance on evaluating quality of container closure systems for drugs, biologics, and combination products.
US Federal Register - FDA Guidance Notices · United StatesSwissmedic and industry associations clarified GMP assessment procedures for foreign manufacturers in authorisation applications and developed joint solutions.
Swissmedic · SwitzerlandFDA 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 StatesFDA draft guidance on developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products.
US Federal Register - FDA Guidance Notices · United StatesFDA invites public comment on proposed recommendations for reauthorizing the Biosimilar User Fee Act for fiscal years 2028–2032.
US Federal Register - FDA Notices · United StatesDEA amends regulations to expand authorization for practitioners to prescribe schedule III-V narcotic drugs for maintenance or withdrawal management via telemedicine, including audio-only encounters.
US Federal Register - DEA Telehealth Rules · United StatesDEA permits mobile components of registered narcotic treatment programs to dispense controlled substances at remote locations without separate registration.
US Federal Register - DEA Telehealth Rules · United StatesSwissmedic updates biosimilar authorisation guidance to align with EMA reflection paper on tailored clinical approaches in biosimilar development.
Swissmedic · SwitzerlandGuidance issued on the conduct and authorisation of complex clinical trials and trials involving seasonal vaccines.
Danish Medicines Agency · DenmarkExport ban for medicinal specialities expanded from EEA-only restriction to general prohibition, effective 9 October 2026, with exception for named-patient use.
Austria BASG · AustriaPharmaceutical product repricing list for 2026 with additions and deletions published under existing ministerial decision.
Greece EOF · GreeceGuidance on procedures for renewing marketing authorisations for medicinal products granted through different regulatory routes.
UK MHRA · UKRevised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes ICH M15 guidance on model-informed drug development planning, evaluation, documentation, and regulatory submission.
US Federal Register - FDA Guidance Notices · United StatesLithuania introduces a new state fee for pharmaceutical product re-registration, effective 3 October 2026, under Government Resolution No. 1458.
Lithuania VVKT · LithuaniaCommission Delegated Regulation (EU) 2026/314 entered into force on 18 May 2026, amending the classification of specific synthetic cathinone and amphetamine precursors.
Latvia ZVA (State Agency of Medicines) · LatviaCzech SUKL publishes the official list of prices and reimbursements for medicinal products under public health insurance.
Czechia SUKL · Czech RepublicMHRA clarifies the UK licensing route for microbiome-based medicines to support developer access.
UK MHRA · UKMHRA guidance to support development and licensing of microbiome-based medicinal products in the UK.
UK MHRA · UKGreece publishes corrected final proposed pharmaceutical prices for Q2 2026, including repricing of reference products following data protection expiry and adjustment of non-reimbursed product prices.
Greece EOF · GreeceFrom 1 September 2026, applicants must use new eAF version 1.28.0.0, aligned with ISO IDMP model and Veterinary Regulation 2019/6.
FAMHP (Belgian Medicine Agency) · BelgiumJoint informative circular on the mandatory use of legally valid medical prescriptions for dispensing prescription medicines.
Portugal INFARMED · PortugalSwissmedic updates guidance on risk management plan information submission under ICH E2E for human medicinal products.
Swissmedic · SwitzerlandEuropean Parliament SANT Committee draft recommendation on the Council's first-reading position on the new Union code for medicinal products, repealing Directives 2001/83/EC and 2009/35/EC.
European Parliament - SANT Subcommittee (Public Health) · EU-wideHHS solicits input on regulatory pathways for deceased donor islet cell therapies for Type 1 diabetes treatment.
US Federal Register - FDA Notices · United States