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-wideFact sheet outlining regulatory changes to medicines and medical devices legislation in the Health Bill.
UK DHSC Policy Papers & Consultations · 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 · 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 StatesEMA and HMA invite comments on new EU-IN guidance describing scientific and regulatory support tools available nationally and at EU level for medicine and technology development.
AEMPS (Spanish Medicine Agency) · SpainFDA 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 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 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 proposes to substitute 'animal' with 'nonclinical' in safety and reporting regulations and align terminology with recent statutory amendments.
US Federal Register - FDA Rules · United StatesGreece 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) · BelgiumFDA draft guidance on evaluating quality of container closure systems for drugs, biologics, and combination products.
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-wide Also reported by European Parliament - SANT Subcommittee (Public Health)Guidance on the MHRA's national assessment procedure for marketing authorisation applications.
UK MHRA · UKFDA 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 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 StatesGuidance on obtaining marketing authorisation for advanced therapy medicinal products (ATMPs) in the United Kingdom.
UK MHRA · UKUpdated Q&A guidance clarifying GLP status requirements for pivotal animal studies in clinical trial applications across all drug development stages.
Danish Medicines Agency · Denmark