Device, software, AI, health-data and reimbursement rules from 77 official sources across the EU, UK, Switzerland and the US. Updated daily.
Updated 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US Federal Register - DEA Telehealth Rules · United StatesFDA draft guidance on evaluating quality of container closure systems for drugs, biologics, and combination products.
US Federal Register - FDA Guidance Notices · United StatesFDA 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US Federal Register - FDA Notices · United StatesFDA announces draft guidance on designing, validating and evaluating potency assays for active immunotherapy products including peptide and protein-based ACTIMPs.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 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 StatesFrom 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) · BelgiumMHRA 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 · UKParliamentary 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)FDA finalizes guidance on therapeutic equivalence evaluations and TE codes for multisource prescription drug products in the Orange Book.
US Federal Register - FDA Notices · United StatesThis guidance summarises our approach to pharmacovigilance
UK MHRA · UKCommission Delegated Regulation (EU) 2024/1701 amending Regulation (EC) No 1234/2008 on changes to marketing authorisation conditions for human medicines enters into force on 1 January 2025, with updated CMDH guidelines and EMA guidance.
Slovakia SUKL · SlovakiaFDA announces draft guidance revising 2019 guidance on choosing between abbreviated and 505(b)(2) approval pathways for marketing applications.
US Federal Register - FDA Guidance Notices · United StatesSummary of types of scientific advice available from the MHRA, the process for obtaining it, and associated fees.
UK MHRA · UKFDA finalizes guidance on formal meetings between the agency and sponsors or applicants of prescription drug and biological products.
US Federal Register - FDA 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 StatesFDA 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 StatesMonthly bulletin reporting new safety information from periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention communications.
AEMPS (Spanish Medicine Agency) · SpainSÚKL published guidance on conditions and procedures for applying for free sale certificates for medicinal products.
Czechia SUKL · Czech Republic