Medicinal products and active pharmaceutical ingredients (APIs) subject to safety, efficacy, and quality regulations, including the assessment of carcinogenic, mutagenic, or reprotoxic (CMR) properties and impurities.
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Last updated
16 May 2026, 08:54
Source-backed regulatory and guidance signals tracked by Foresight, with the newest developments first.
Italy: Authorised SmPC, Leaflet and Labelling Update for ASTIAN (S.F. Group S.r.l.)
Italy has authorised a Type C.3.b variation to update the SmPC, patient leaflet, and labelling for the medicinal product ASTIAN, with immediate effect for the SmPC and short transition deadlines for packaging and pharmacy practice. Marketing and regulatory teams must coordinate timely artwork and leaflet updates while ensuring pharmacists can provide the revised patient information from mid-June 2026, with non-updated stock allowed to sell through until expiry.
ItalyOklahoma Legislature Approves Permanent Rules for Health-Related Agencies (HJR 1093)
Joint Resolution HJR 1093, passed by the Oklahoma Legislature in May 2026, approves permanent rules filed by a broad set of state health-related agencies (including the Health Care Authority and State Board of Pharmacy) for the 2026 rulemaking cycle, while explicitly excluding a defined subset of Medicaid rules. This consolidates the year’s regulatory changes for key health, Medicaid and pharmacy regulators, signalling that any previously proposed requirements for providers, payers and pharmacies are moving toward implementation and should be reviewed against existing compliance plans.
United StatesHawaiʻi Department of Health Warns Public About 7‑Hydroxymitragynine (7‑OH)
In May 2026, the Hawaiʻi Department of Health issued a public warning about the emerging opioid-like substance 7-hydroxymitragynine (7-OH), highlighting its sale in concentrated “enhanced kratom” products and associated risks of addiction, overdose, and severe health effects. This alert, alongside FDA enforcement and potential Schedule I classification under the federal Controlled Substances Act, signals rising regulatory and liability pressure on kratom-derived products and calls for heightened vigilance from manufacturers, retailers, and healthcare providers.
United StatesUS FDA OPDP Issues Untitled Letter to Alnylam Over AMVUTTRA ATTR-CM Survival Claims
In April 2026, FDA’s Office of Prescription Drug Promotion issued an Untitled Letter to Alnylam over AMVUTTRA website content that, in FDA’s view, misleadingly claimed a quantified survival benefit in transthyretin-mediated cardiomyopathy based on open-label extension data. The action requires Alnylam to halt the challenged communications and report back within 15 working days, signalling to other sponsors that FDA will closely scrutinise mortality and long-term outcomes claims drawn from non-randomised extensions in promotional materials.
United StatesIndia BIS Consults On Draft Standards For Orthosiphon Root And Hydrogen Generators
In May 2026, the Bureau of Indian Standards opened public consultations on a new Indian Standard for Orthosiphon rubicundus root used in traditional medicine and a second revision of IS 16509 on safety requirements for hydrogen generators using water electrolysis. These drafts signal upcoming Indian specifications for herbal raw materials and hydrogen equipment that could shape quality controls, testing expectations, and certification conditions for suppliers to the Indian market, so impacted firms should review and consider commenting before the July 2026 deadline.
IndiaItaly: Official Gazette Communication on GLEXAR SmPC, Leaflet and Labelling Updates
Italy’s Official Gazette has authorised updates to the product information for the medicinal product GLEXAR, setting concrete timelines for changes to the SmPC, patient leaflet and labelling. Epifarma and downstream pharmacists must update materials and provide revised leaflets within defined 30‑day and six‑month windows, requiring coordinated implementation across manufacturing, packaging and pharmacy distribution to avoid non‑compliance.
ItalyItaly: Type IB Variation for ANTUNES – SPC, Leaflet and Label Updates
Italy has approved a Type IB variation for the medicinal product ANTUNES, updating its summary of product characteristics, patient leaflet and labelling with phased implementation deadlines. The marketing authorisation holder and pharmacists must update printed and digital materials within 30 days and six months of publication so patients receive the revised safety and use information in time.
ItalyItaly – AIFA Revokes Marketing Authorisation for Medicinal Product Tubercolinum Koch
The Italian Medicines Agency has revoked, at the holder’s request, the marketing authorisation for the human medicinal product Tubercolinum Koch, with the decision published in the Official Gazette on 14 May 2026. Distributors and healthcare providers must ensure any remaining in-date stocks are sold or used within 180 days of publication, after which the product should no longer be placed on the Italian market.
ItalyItaly AIFA Grants Marketing Authorisation for Uvesol (Clobetasol Propionate) Eye Drops
In May 2026 Italy’s medicines agency authorised Uvesol (clobetasol propionate eye drops) for the national market via an AIFA determination published in the Gazzetta Ufficiale, with validity aligned to the EU renewal date in 2030. This adds a new corticosteroid eye-drop option under restricted prescription and provisional class C(nn) reimbursement status, so hospital pharmacies and prescribers should plan formulary inclusion, pricing, and pharmacovigilance arrangements accordingly.
ItalyOhio HB 892 Would Establish Ohio-Made Medicine Manufacturing Program
Ohio legislators have introduced HB 892, the Ohio-Made Prescription Drug Act, to establish a state-run programme that partners with manufacturers and payers to improve the affordability and availability of generically equivalent medicines. If enacted, this could reshape how generic drugs are sourced, priced, and prioritised for Ohio public and private purchasers, creating new opportunities and expectations for manufacturers and healthcare payers involved in essential medicines.
United StatesUS FDA CDER Updates Safety Labelling For Eligard, Lupron, Ocrevus, Vantas And Zoladex
In May 2026 the US FDA’s drug division (CDER) approved safety labelling supplements for several GnRH agonists (Eligard, Lupron, Vantas, Zoladex) and for Ocrevus, adding or strengthening warnings on suicidal ideation, severe skin reactions, infections, malignancy, liver injury and paediatric use. These binding label changes require manufacturers to update US prescribing information and patient materials, enhance clinician and patient counselling on psychiatric and infection risks, and review pharmacovigilance and risk‑minimisation strategies for the affected oncology and multiple sclerosis products.
United StatesArgentina ANMAT Ends Its Intervention In Import/Export Authorisations For Somatropin Products
Argentina’s medicines regulator ANMAT has removed somatropin from its list of substances under special control and will no longer intervene in import and export authorisation procedures for products containing this hormone. This change simplifies ANMAT-specific controls on somatropin trade from mid-May 2026, reducing administrative friction for pharmaceutical supply chains while leaving broader medicinal and trade obligations in place.
ArgentinaCommunity of Madrid Authorises Electronic Narcotics Accounting Book via LICO
In April 2026 the Community of Madrid authorised the official narcotics accounting book to be kept electronically via the national LICO system managed by the medicines agency, formalised by a resolution published in May 2026. This modernises controlled-substance record-keeping for pharmacies and other operators in Madrid, providing a standardised digital ledger that strengthens traceability and audits without changing which narcotics are regulated.
SpainUS FDA Publishes Nationwide Recall of MG217 Eczema Cream for Staphylococcus Aureus Contamination
In May 2026 Pharmacal initiated, and FDA published, a nationwide recall of one lot of MG217 Multi-Symptom Treatment Cream and Skin Protectant Eczema Cream after testing found contamination with the bacterium Staphylococcus aureus. Manufacturers, distributors, and retailers of over-the-counter dermatological products in the United States should identify and remove the affected lot from inventory, notify customers, and review quality controls to mitigate similar microbial contamination risks.
United StatesColorado General Assembly Passes HB26-1325 on Ibogaine Research and Natural Medicine Licensing
In May 2026 the Colorado General Assembly passed HB26-1325, expanding the state’s natural medicine framework to cover ibogaine, creating a conditional ibogaine research pilot program, and tightening licensing, benefit-sharing and advertising rules for natural medicine businesses, with an effective date in August 2026 subject to referendum and funding triggers. These changes signal a more formalised, research-driven and compliance-heavy environment for psychedelic and natural medicine services in Colorado, affecting how ibogaine can be supplied and administered, how healing centres structure sales and licences, and how harm reduction and support services can be marketed and documented.
United StatesChina CDE Publishes 2025 Annual Drug Evaluation Report
China’s Center for Drug Evaluation has published its 2025 Annual Drug Evaluation Report, detailing last year’s growth in drug registration activity, innovative and rare disease approvals, and extensive use of accelerated review pathways. The report signals continued prioritisation of clinically valuable innovation, expanded technical guidance and ICH alignment, and further digitalisation and reform of China’s drug review system in 2026, shaping expectations for sponsors’ development and submission strategies.
ChinaAustralia TGA Publishes Guidance on Lawful Compounding of Medicines
In May 2026 Australia’s Therapeutic Goods Administration published detailed guidance consolidating the legislative requirements for manufacturing, supplying and advertising compounded medicines. Health practitioners and sponsors involved in compounding now need to reassess licensing status, ARTG exemptions, high‑risk product categories and advertising practices to avoid unlawful manufacture or supply and the risk of substantial civil or criminal penalties.
AustraliaOhio Legislature Enrolls HB 462 on Nasal Epinephrine Delivery Devices for Schools and Camps
In May 2026, the Ohio General Assembly enrolled HB 462, a bill authorizing schools, school districts, and camps to procure and use additional nasal epinephrine delivery devices for emergency treatment of anaphylaxis, with the measure now awaiting the Governor’s action. If enacted, operators of Ohio schools and camps will need to update epinephrine procurement, storage, and emergency-response policies, while pharmaceutical and device suppliers should prepare for increased demand and scrutiny of product suitability and instructions for school settings.
United StatesChina NMPA Issues 105th Batch of Generic Drug Reference Preparations Directory (Notice No. 17 of 2026)
China’s National Medical Products Administration has issued Notice No. 17 of 2026 to publish the 105th batch of its Catalogue of Reference Preparations for Generic Drugs, with an attached directory of reference products used in quality and efficacy consistency evaluations. Generic drug developers should review the updated list to see whether their products are affected and align upcoming bioequivalence and consistency studies and related submissions with the latest NMPA reference preparations.
ChinaNew Zealand Proposes Widening Funded Access to Type 2 Diabetes Medicines
New Zealand’s government has welcomed a Pharmac proposal to widen funded access to three type 2 diabetes medicines by revising clinical eligibility criteria from August 2026. If implemented, this would expand the reimbursed market for empagliflozin, liraglutide and dulaglutide in New Zealand and signals a broader shift to needs-based, ethnicity-neutral medicines funding.
New ZealandThese are just a few of the most recent Pharmaceuticals alerts. Foresight tracks every jurisdiction, every day — and surfaces only what affects your portfolio, with full citations and evidence.
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Definition
Medicinal products and active pharmaceutical ingredients (APIs) subject to safety, efficacy, and quality regulations, including the assessment of carcinogenic, mutagenic, or reprotoxic (CMR) properties and impurities.
Industry relevance
Pharmaceuticals developments can change product scope, supplier expectations, market access, reporting duties, and risk ownership. Foresight tracks the signals early so teams can respond before obligations become urgent.
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Foresight monitors official sources, extracts structured regulatory intelligence, and maps alerts to a customer's products, substances, markets, and priorities so teams see the relevant signal with source evidence for review.
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