Device, software, AI, health-data and reimbursement rules from 75 official public sources across the EU, UK, Switzerland and the US — all of it stored and classified, so you can filter to what binds you. Translated to English. Updated daily.
Parliamentary amendments to proposed European Biotech Act framework amending regulations on food safety, advanced therapies, clinical trials, veterinary medicines, and biomanufacturing.
European Parliament - SANT Subcommittee (Public Health) · EU-wide Also reported by European Parliament - SANT Subcommittee (Public Health)FDA draft guidance clarifies recommendations for developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products.
US Federal Register - FDA Guidance Notices · United StatesDEA and HHS postponed effective dates of final rules expanding buprenorphine telemedicine treatment and VA continuity-of-care telemedicine from February 18 to March 21, 2025, pending further policy 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 allowing telemedicine prescribing of controlled medications without prior in-person evaluation, pending final rulemaking.
US Federal Register - DEA Telehealth Rules · United StatesSwissmedic updates guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway, effective 01.08.2026.
Swissmedic · SwitzerlandCover letters for Type IA pharmaceutical variation applications no longer required; new rules effective 1 July 2026.
Poland URPL · PolandDEA and HHS delayed the effective date of two final rules expanding buprenorphine telemedicine treatment and VA continuity of care via telemedicine from February 18 to March 21, 2025.
US Federal Register - DEA Telehealth Rules · United StatesDEA proposes 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 StatesDEA and HHS amend regulations to permit practitioners to prescribe schedule III-V controlled substances for opioid use disorder via audio-only telemedicine, including initial six-month supplies after PDMP review.
US Federal Register - DEA Telehealth Rules · United StatesDEA expands authorization for practitioners to prescribe schedule III-V narcotic drugs for maintenance and withdrawal management via telemedicine, including audio-only encounters.
US Federal Register - DEA Telehealth Rules · United StatesDEA proposes rule permitting controlled-substance prescribing via telemedicine without prior in-person evaluation in limited circumstances.
US Federal Register - DEA Telehealth Rules · United StatesDEA finalizes regulations implementing the SUPPORT Act's expansion of medication-assisted treatment for opioid use disorder, including telehealth dispensing and practitioner qualification requirements.
US Federal Register - DEA Telehealth Rules · United StatesFDA finalizes ICH M15 guidance on model-informed drug development planning, evaluation, documentation, and regulatory submission.
US Federal Register - FDA Guidance Notices · United StatesFDA revises 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 StatesILAP guidance explains an accelerated regulatory pathway for transformative new medicines to reach UK patients faster.
UK MHRA · UKFDA revises draft guidance on in vivo skin irritation and sensitization study design and conduct for transdermal and topical delivery systems in ANDAs.
US Federal Register - FDA Guidance Notices · United StatesFDA issues final guidance on study design and conduct for evaluating adhesion performance of transdermal and topical delivery systems in generic drug applications.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes guidance on washout periods and concomitant medication exclusions in cancer clinical trial eligibility criteria.
US Federal Register - FDA Guidance Notices · United StatesEC Public Health invites tenders for framework contracts to accelerate development and access to next-generation infectious disease therapeutics.
EC Public Health · EU-wideEuropean Pharmacopoeia 12.3 becomes binding in Poland from 1 July 2026, replacing version 12.2; from edition 12, available only in electronic format.
Poland URPL · PolandFDA finalizes guidance on clinical trial design and conduct considerations for sponsors developing psychedelic drugs to treat psychiatric and substance use disorders.
US Federal Register - FDA Guidance Notices · United StatesFDA proposes to amend drug establishment registration and listing rules for distributed manufacturing and foreign establishments, implementing the PREVENT Pandemics Act.
US Federal Register - FDA Rules · United StatesEuropean Pharmacopoeia Edition 12.3 becomes binding on 1 July 2026.
Swissmedic · SwitzerlandTamoxifen may be prescribed and dispensed only in single-pack quantities per prescription, with minimum 21-day intervals between refills.
Czechia SUKL · Czech RepublicCzech SUKL publishes the official list of prices and reimbursement rates for medicinal products under the Public Health Insurance Act.
Czechia SUKL · Czech RepublicUpdated reimbursement list for medicines covered by Czech public health insurance, incorporating SÚKL and Ministry of Health decisions effective to 15 July 2026.
Czechia SUKL · Czech RepublicTemplates for patient information and healthcare professional information for human medicinal products are being changed, effective 1 July 2026.
Swissmedic · SwitzerlandNew Slovak Pharmaceutical Code (third edition, effective 15 July 2026) updates national requirements and incorporates European Pharmacopoeia standards for compounded medicines prepared in pharmacies.
Slovakia SUKL · SlovakiaFDA revises draft guidance on design, analysis and regulatory submission of master protocol trials for drugs and biologics.
US Federal Register - FDA Guidance Notices · United States