Health policy and regulation from official public bodies across the EU, UK, Switzerland, Norway and the US.
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European Parliament - SANT Subcommittee (Public Health) · EU-wideFDA revises draft guidance on drug delivery device performance characteristics, data organization and regulatory review standards for combination products.
US Federal Register - FDA Guidance Notices · United StatesFDA guidance on regulatory application of drug labeling authorities to software outputs disseminated by or on behalf of drug sponsors for use with prescription drugs.
US Federal Register - FDA Guidance Notices · United StatesFact sheet outlining regulatory changes to medicines and medical devices legislation in the Health Bill.
UK DHSC Policy Papers & Consultations · UKEMA provides training on electronic reporting of individual case safety reports in ICH E2B(R3) format via EudraVigilance.
EMA - European Medicines Agency · EU-wideFDA 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 StatesMHRA guidance on the use of real-world data and real-world evidence in regulatory decision-making for medicines and medical devices.
UK MHRA · UKDEA 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 StatesSMC publishes guidance for pharmaceutical companies on using artificial intelligence in submissions to the Scottish Medicines Consortium.
Scottish Medicines Consortium · UKImpact assessment framework for proposed Medicines and Healthcare products Regulatory Agency reforms under the Health Bill.
UK DHSC Policy Papers & Consultations · UKMHRA and RIO invite stakeholder input on artificial intelligence use in medicines development and safety.
UK MHRA · UKA national programme to drive healthcare advancements and accelerate patient access to innovation and new treatments.
UK MHRA · UKFDA draft guidance on BLA submission and postapproval management for individualized genome editing products with multiple variants.
US Federal Register - FDA Guidance Notices · United StatesSMC releases updated submission templates and guides, and issues a position statement on AI use in medicines submissions.
Scottish Medicines Consortium · UKDEA 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 StatesDEA 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 StatesUpdated guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway.
Swissmedic · SwitzerlandFDA draft guidance on evaluating quality of container closure systems for drugs, biologics, and combination products.
US Federal Register - FDA Guidance Notices · United StatesCMDh updated procedural advice allowing RMS to initiate procedures when CMS fails to respond within deadline; revised RMS request templates for DCP and MRP/RUP.
Austria BASG · AustriaSingapore designated as a recognised third country for pharmaceutical active substance importation into the EU.
EC Public Health · EU-wideFrom 1 July 2026, IA/IAin type regulatory amendment applications may be submitted without cover letters under decentralised, mutual recognition and national procedures.
Lithuania VVKT · Lithuania