Pharmaceutical regulation governs how medicines are authorised, manufactured, monitored, and reimbursed. In Europe the European Medicines Agency runs the centralised authorisation procedure, while national agencies such as Germany's BfArM and the UK's MHRA handle national and decentralised routes. This page collects the regulatory updates HealthSignal tracks on marketing authorisations, pharmacovigilance and safety signals, manufacturing and Good Manufacturing Practice, shortages, and the wider pharmaceutical legislation package, drawn only from official public sources.
Updated guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway.
Swissmedic · SwitzerlandFDA 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 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 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-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 ICH M15 guidance on model-informed drug development planning, evaluation, documentation, and regulatory submission.
US Federal Register - FDA Guidance Notices · United StatesRevised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products.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 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 StatesJoint 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 · UKEuropean Pharmacopoeia Edition 12.3 becomes effective on 1 July 2026.
Swissmedic · SwitzerlandFDA announces biosimilar user fee rates for FY 2027 under the Biosimilar User Fee Amendments of 2022.
US Federal Register - FDA Notices · United StatesMHRA publishes scientific assessment reports explaining the evidence and reasoning behind regulatory decisions on medicine safety.
UK MHRA · UKEuropean Pharmacopoeia 12.3 becomes binding in Poland and other adopting states from 1 July 2026, replacing 12.2; from edition 12, available only in electronic format.
Poland URPL · PolandNew edition of Slovak Pharmaceutical Code published 15 July 2026, updating national requirements and incorporating European Pharmacopoeia standards for compounded medicines.
Slovakia SUKL · SlovakiaFinal 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 StatesPublic consultation on proposed new and revised European Pharmacopoeia articles open until 30 September 2026.
Slovakia SUKL · SlovakiaDEA 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 clinical trial design and conduct for psychedelic drug development in psychiatric and substance use disorder treatment.
US Federal Register - FDA Guidance Notices · United StatesHow to get information including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).
UK MHRA · UKOverview of DHSC and NHS England systems and processes for responding to medicine shortages across the UK supply chain.
UK DHSC · UKGuidance on roles and responsibilities of marketing authorisation holders, wholesalers and procurers in maintaining medicine supply and minimising shortages.
UK DHSC · UKMonthly safety bulletin reporting periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention information materials.
AEMPS (Spanish Medicine Agency) · SpainMedicinrådet publishes a new national basic medicines list replacing regional lists, covering 15 common disease areas with drug-choice recommendations for primary care.
Medicinrådet (Danish Medicines Council) · DenmarkFDA announces prescription drug user fee rates for FY 2027 under PDUFA VII.
US Federal Register - FDA Notices · United StatesMonthly bulletin reporting new safety information from periodic pharmacovigilance data evaluation and AEMPS-authorised risk-prevention materials.
AEMPS (Spanish Medicine Agency) · SpainMonthly safety bulletin reporting periodic pharmacovigilance data evaluation, authorised risk-prevention information, and other relevant safety matters.
AEMPS (Spanish Medicine Agency) · SpainUpdated list of medicinal products reimbursed from public health insurance, incorporating SUKL and Ministry of Health decisions effective by 15 July 2026.
Czechia SUKL · Czech RepublicTemplates for patient information and healthcare professional information for human medicinal products are being changed, effective 01.07.2026.
Swissmedic · SwitzerlandCMS issued draft guidance on processes and requirements for manufacturers to implement maximum fair prices in the 2028 Medicare drug price negotiation program.
US CMS Newsroom · United StatesGuidance on how to use the International Recognition Procedure for medicines licensing applications.
UK MHRA · UKFDA 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 StatesRevision and approval dates in product information for medicinal products now presented in new format from 1 June 2026.
FAMHP (Belgian Medicine Agency) · BelgiumILAP is a pathway to accelerate regulatory approval and NHS access for transformative new medicines.
UK MHRA · UK29. maj 2026
Medicinrådet (Danish Medicines Council) · DenmarkFDA announces fiscal year 2027 fee rates for generic drug applications, facilities, and applicant programs under GDUFA III.
US Federal Register - FDA Notices · United StatesFDA publishes user fee rates for OTC monograph drug manufacturers and submitters for fiscal year 2027 under OMUFA II.
US Federal Register - FDA Notices · United StatesSUKL publishes a corrected list of prices and reimbursements for medicinal products under the public health insurance law.
Czechia SUKL · Czech RepublicCzech SUKL publishes the official list of prices and reimbursement rates for medicinal products under public health insurance.
Czechia SUKL · Czech RepublicFDA 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 States