Pharmaceutical regulation governs how medicines are authorised, manufactured, monitored, and reimbursed. The European Medicines Agency runs the EU's centralised authorisation procedure, while national agencies such as Germany's BfArM and the UK's MHRA handle the national and decentralised routes.
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US Federal Register - DEA Telehealth Rules · United StatesFDA draft guidance on evaluating quality of container closure systems for drugs, biologics, and combination products.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US Federal Register - FDA Notices · United StatesFDA announces draft guidance on designing, validating and evaluating potency assays for active immunotherapy products including peptide and protein-based ACTIMPs.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 StatesSwissmedic requires electronic adverse drug reaction reporting via ElViS (E2B(R2)) or gateway (transitioning from E2B(R2) to E2B(R3) from Q3 2024).
Swissmedic · SwitzerlandFrom 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-wideParliamentary 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-wideFDA 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 StatesFinal rule implements SUPPORT Act amendments to expand practitioner qualifications and pharmacy delivery options for opioid-use-disorder medication-assisted treatment via telehealth.
US Federal Register - DEA Telehealth Rules · 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 StatesSÚKL published guidance on conditions and procedures for applying for free sale certificates for medicinal products.
Czechia SUKL · Czech RepublicSUKL explains three levels of medicine recalls based on quality defects and patient risk; only patient-level recalls require return to pharmacy.
Czechia SUKL · Czech RepublicFinland's Fimea has extended temporary special authorisations for human medicines.
Finland Fimea · FinlandUpdated list of medicinal products reimbursed from public health insurance, incorporating SUKL and Ministry of Health decisions effective by 15 August 2026.
Czechia SUKL · Czech RepublicFrom 15 January 2026, all applications for changes to human medicinal product registrations must follow updated CMDh/EMA classification guidelines for variation categories 1A, 1B and II.
Slovakia SUKL · SlovakiaGuidance on reporting requirements for marketing authorisation holders regarding initiation, suspension, resumption and termination of medicinal product distribution, including supply disruption notification and inventory obligations.
Czechia SUKL · Czech RepublicHow to get information including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).
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 StatesFDA revises draft guidance on design, analysis and regulatory submission of master protocol trials for drug and biological product development.
US Federal Register - FDA Guidance Notices · United StatesMedicinrådet publishes treatment algorithm and overview of recommended medicines for type 2 diabetes based on efficacy, adverse effects and price.
Medicinrådet (Danish Medicines Council) · DenmarkILAP is a pathway to accelerate regulatory approval and NHS access for transformative new medicines.
UK MHRA · UKCzech SUKL publishes the official list of prices and reimbursements for medicinal products under public health insurance.
Czechia SUKL · Czech RepublicJoint 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 · SwitzerlandGuidance on transitional arrangements for the Clinical Trials Regulations.
UK MHRA · UKFDA revises draft guidance on clinical evidence standards for drug effectiveness, clarifying reliance on one adequate and well-controlled investigation with confirmatory evidence.
US Federal Register - FDA Guidance Notices · United StatesFDA announces draft guidance on designing and analyzing pharmacokinetic studies in hepatically impaired patients, withdrawing the 2003 version.
US Federal Register - FDA Guidance Notices · United StatesGuidance on anticoagulation therapy strategy for healthcare professionals.
Czechia SUKL · Czech Republic