Texas Pharmacy Rules Updated

The Texas State Board of Pharmacy has updated its rules following a recent board meeting. This notice serves to inform stakeholders about the changes made to existing pharmacy regulations.

WHO Handbook Accelerates Hepatitis Elimination Action

The World Health Organization (WHO) has released a new implementation handbook to support countries in accelerating action towards hepatitis elimination by 2030. The handbook consolidates evidence-based recommendations and provides practical guidance for expanding prevention, testing, and treatment services.

WHO Releases New Antibiotic Profiles for Drug-Resistant Infections

The World Health Organization (WHO) has released three new Target Product Profiles (TPPs) for antibacterial agents to address critical drug-resistant infections. These profiles guide the development of new antibiotics for multidrug-resistant Gram-negative infections, Gram-positive infections in vulnerable patients, and bacterial meningitis.

Teva Octreotide Recalled Due to Manufacturing Deficiencies

Health Canada has issued a Type I drug recall for Teva Octreotide due to manufacturing site deficiencies identified at a foreign facility. These deficiencies could lead to potential quality issues, including compromised sterility and dosing accuracy. The recall is a precautionary measure.

Health Canada Health Product InfoWatch - February 2026

Health Canada's February 2026 Health Product InfoWatch includes a monthly recap of safety information, including a recall of Teva Octreotide and advisories on unauthorized products. It also announces a consultation on controlling zuranolone and new market authorizations with conditions.

Health Canada Health Product Safety Recap

Health Canada has issued its February 2026 Health Product InfoWatch, detailing recalls for Teva Octreotide due to GMP deficiencies and unauthorized health products. It also announces a consultation on controlling zuranolone under the Controlled Drugs and Substances Act.

PMDA Japan Drug Precaution Revisions

The PMDA Japan has updated drug precautions for several medications, including Andexanet alfa, Topiramate, and various VEGF/VEGFR inhibitors. These revisions reflect new safety information and investigation results, impacting the labeling and handling of these drugs.

Japan PMDA Drug Precaution Revisions for FY2025

The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has published a list of drug precaution revisions for Fiscal Year 2025, detailing updates for various nonproprietary drug names. These revisions are effective on specific dates in late 2025 and early 2026, with associated investigation summaries available.

HSA Charges Man for Trafficking Etomidate Vaporiser Pods

The Health Sciences Authority (HSA) of Singapore has charged a 34-year-old man for allegedly trafficking etomidate vaporiser pods. The charges follow an enforcement operation where HSA seized over 900 tablets, cough syrup, and etomidate-containing vaporiser pods. Stricter penalties for etomidate trafficking are in effect.

HSA Deepens International Partnerships for Biomedical Sector Growth

The Health Sciences Authority (HSA) of Singapore has announced deepened collaborations with Malaysia and Uzbekistan to facilitate access to medicines and medical devices. These partnerships include a formalised Medical Device Regulatory Reliance Programme with Malaysia and a Memorandum of Understanding with Uzbekistan for broader regulatory cooperation.

Therapeutic Product Approvals and Indications List Update

The Health Sciences Authority (HSA) of Singapore has published updated lists of new therapeutic product approvals and new indications for registered therapeutic products, effective March 2026. These lists are intended for healthcare professionals and industry members.

Raymond Chua's address at 29th Medical Device Regulators Forum

Raymond Chua's address at 29th Medical Device Regulators Forum

HSA Achieves WHO ML4 Recognition for Medical Devices, Expands Biomedical Role

The Health Sciences Authority (HSA) in Singapore has achieved the highest World Health Organization (WHO) Maturity Level (ML4) for medical devices regulatory systems, becoming the first national authority globally to do so. HSA is also expanding its economic role to support the biomedical sector's growth.

TGA Releases Compliance Principles for 2026-2027 Enforcement

The Therapeutic Goods Administration (TGA) has released its compliance principles for 2026-2027, outlining a refreshed, proactive, and risk-based approach to enforcement for therapeutic goods in Australia. The principles apply across all TGA-regulated areas and will be reviewed every two years.

TGA Seizes Illegal Vapes Sold to Young People

The Therapeutic Goods Administration (TGA) in Australia, with police support, seized illegal vaping products from a store in Inverloch, Victoria, allegedly sold to minors. The TGA is investigating further regulatory action and warns retailers against targeting young people with illicit vapes.

TGA Seizes 57,000 Illegal Vaping Goods in NSW Crackdown

The Therapeutic Goods Administration (TGA) in Australia, with law enforcement support, seized over 57,000 illegal vaping products in Burwood, NSW. This action targets the illicit supply of vapes, with significant penalties including fines and imprisonment for non-compliance with the Therapeutic Goods Act 1989.

Prime Medic Group Fined for Unlawful Weight Loss Medicine Advertising

The Therapeutic Goods Administration (TGA) has issued infringement notices totaling $23,760 to Prime Medic Group and an individual for allegedly unlawfully advertising prescription-only weight loss medicines. Prime Medic Group paid the fines in January 2026.

TGA Issues Infringement Notices for Unlawful Importation and Advertising

The Therapeutic Goods Administration (TGA) has issued 11 infringement notices totaling $43,560 to 6 individuals for alleged unlawful importation of unapproved therapeutic goods and unlawful advertising of prescription-only medicines. These actions underscore the TGA's commitment to protecting public health.

TGA Safety Alert: Ayurvedic Tablets Contain High Heavy Metals

The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Kumar Kalyan Rasa tablets, an Ayurvedic medicine. Testing revealed extremely high concentrations of heavy metals, including mercury, lead, arsenic, and cadmium, posing serious health risks to consumers, particularly pregnant women and children. The TGA urges consumers to exercise extreme caution with such products.

TGA Safety Alert: Counterfeit Botox Vials Continue to be Imported

The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding the continued importation of counterfeit Botox vials into Australia. These products, packaged to appear genuine but confirmed as fake by AbbVie, pose significant public health risks and cannot be legally imported under any circumstances.

Safety Concerns Over Imported Counterfeit Melatonin Products

The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding imported counterfeit unregistered melatonin products. Laboratory testing revealed significant discrepancies in melatonin content, with some products containing over 400% of the labelled amount and others none at all, posing serious risks to consumers, especially children.

TGA Safety Advisory: Counterfeit GLP-1 Weight Loss Products

The Therapeutic Goods Administration (TGA) has issued an updated safety advisory regarding counterfeit weight loss products falsely claiming to contain GLP-1 receptor agonists. Laboratory testing confirmed these products contain no active GLP-1 ingredients and are not included in the Australian Register of Therapeutic Goods.

TGA Safety Alert: Natures Valley Collagen Builder contains undeclared sildenafil

The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Natures Valley Collagen Builder tablets, which were found to contain undeclared sildenafil. Consumers are warned that the product poses a serious health risk and should not be taken.

Yttrium Citrate (90Y)-YMM-1 Failed Sterility Test

Swissmedic has issued a communication regarding Citrate d'Yttrium (90Y)-YMM-1, Suspension for Injection, batch Z008. The batch failed its sterility test after incubation. While no immediate patient danger is expected, affected patients require close monitoring.

Cytosar (cytarabinum) Barcode Expiry Date Discrepancy Alert

Swissmedic has issued a Health Professional Communication regarding a barcode expiry date discrepancy for Cytosar (cytarabinum) 2g/20ml, batch CT32407B. The date encoded in the 2D barcode on the vial label is incorrect and does not match the legible expiry date printed on the vial.

Keppra (Levetiracetam) Syringe Change and Medication Error Risk

Swissmedic and UCB-Pharma AG are issuing a communication regarding a change in the application syringe for Keppra (Levetiracetam) oral solution. A new 5 ml syringe replaces the 3 ml syringe for children aged 6 months to 4 years, requiring healthcare professionals to inform caregivers about the change and proper dosing to prevent medication errors.

Voxzogo (vosoritidum) Packaging Text Error Identified

Swissmedic has identified a packaging text error on Voxzogo (vosoritidum) outer packaging. The incorrect dosage information was printed on specific batches, and affected batches have been identified. The company has issued an information letter detailing the error and corrective actions.

PRAC Recommends EU Market Withdrawal of Levamisole Medicines

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of marketing authorizations for medicines containing levamisole from the EU market. This decision is based on a re-evaluation of safety data, concluding that the risks associated with these drugs outweigh their benefits for treating parasitic worm infections.

ANSM Recalls Risks of Varicose Vein Sclerosing Agents

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a notice recalling the serious cardiovascular risks associated with varicose vein sclerosing agents. The agency emphasizes adherence to recommendations and provides new tutorials for reporting adverse events.

ANSM Warns of Significant Risks from Off-Label Isotretinoin Use

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a warning regarding the off-label promotion and use of isotretinoin-based medications for aesthetic purposes on social media. The agency emphasizes that these drugs are strictly indicated for severe acne and carry significant risks, including psychiatric disorders and birth defects.

Doliprane Suspension Recall Due to Pipette Wear-Off

The French Agency for the Safety of Medicines and Health Products (ANSM) has announced a recall of 27 lots of Doliprane 2.4% oral suspension due to a manufacturing defect causing pipette graduations to wear off. This defect poses a risk of incorrect dosage and potential overdose in infants and young children.

ANSM Ensures Continuity of Emend 125 mg Oral Suspension for Children

The ANSM has announced measures to ensure the continuity of treatment for children using Emend 125 mg oral suspension due to supply difficulties. Prescribers are advised to reserve the oral suspension for specific pediatric cases and explore alternative formulations for older children and adults. Importations are being arranged to cover demand.

EMA CHMP Meeting Agenda February 2026

The European Medicines Agency (EMA) has published the draft agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for February 23-26, 2026. The agenda outlines topics for discussion, including pre-authorisation and post-authorisation procedures for various medicinal products.

EMA CHMP Meeting Minutes July 2025

The European Medicines Agency (EMA) has published the minutes from the Committee for Medicinal Products for Human Use (CHMP) meeting held from July 21-24, 2025. The document details discussions and opinions on various medicinal products, including initial applications and re-examinations.

MHRA Safety Roundup February 2026: Falsified Mounjaro Pens

The MHRA has issued a safety alert regarding falsified Mounjaro KwikPen 15mg pre-filled pens found in the UK. The affected pens, batch number D873576, have faulty mechanisms and should not be supplied or used. Healthcare professionals are advised to quarantine and return affected stock.

Pflaumer et al v. ACE Hardware Corporation - Civil Case Filing

A new civil case, Pflaumer et al v. ACE Hardware Corporation, has been filed in the U.S. District Court for the Northern District of California. The case, bearing number 5:26-cv-02151, was filed on March 12, 2026, with a filing fee of $405. The initial filings include the complaint, proposed summons, and a certificate of interested entities.

GLP-1/GIP Agonists: Strengthened Pancreatitis Warnings

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated product information for GLP-1 and dual GLP-1/GIP receptor agonists to strengthen warnings about the risk of severe acute pancreatitis, including necrotising and fatal cases. Healthcare professionals are advised to be vigilant and report suspected adverse reactions.

Semaglutide Drug Linked to Optic Neuropathy Risk

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding a rare risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) associated with semaglutide (Wegovy, Ozempic, Rybelsus). Healthcare professionals are advised to refer patients with sudden vision loss for ophthalmological examination and to consider discontinuing semaglutide if NAION is confirmed.

Chikungunya Vaccine (IXCHIQ) Use Restrictions Updated

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has updated restrictions for the IXCHIQ Chikungunya vaccine following a safety review. The vaccine is no longer indicated for individuals over 60 and is contraindicated for those with hypertension, cardiovascular disease, diabetes, or chronic kidney disease.

Falsified Mounjaro KwikPen 15mg Pens Found in UK

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a notice regarding falsified Mounjaro KwikPen 15mg pre-filled pens found supplied through an online pharmacy. Batch number D873576 is affected, and the pens have a faulty mechanism, posing a safety risk to patients.

Isotretinoin Prescribing Guidance Updated

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated prescribing guidance for isotretinoin, removing the requirement for a second prescriber for patients under 18. New risk minimisation measures, including an updated Acknowledgement of Risk Form, have been introduced to ensure safe prescribing.

NICE Guidance: Setmelanotide for Bardet-Biedl Syndrome

The UK's National Institute for Health and Care Excellence (NICE) has published highly specialised technologies guidance on setmelanotide (Imcivree) for treating obesity and hyperphagia in Bardet-Biedl syndrome. The guidance provides evidence-based recommendations for patients aged 6 years and over, with specific criteria for treatment initiation.

NICE Guidance: Olipudase alfa for Niemann-Pick disease types AB and B

NICE has published highly specialised technologies guidance (HST32) on the use of olipudase alfa (Xenpozyme) for treating Niemann-Pick disease types AB and B. The guidance provides evidence-based recommendations for healthcare professionals and commissioners in the UK.

NICE Guidance: Leniolisib for PI3K delta syndrome

NICE has published highly specialised technologies guidance on the use of leniolisib (Joenja) for treating activated phosphoinositide 3-kinase delta syndrome in individuals aged 12 and over. The guidance includes evidence-based recommendations and information on commercial arrangements for NHS organisations.

Cerliponase alfa for Neuronal Ceroid Lipofuscinosis Type 2 Guidance

NICE has published updated highly specialised technologies guidance (HST34) on cerliponase alfa (Brineura) for treating neuronal ceroid lipofuscinosis type 2 in children. This guidance replaces previous guidance and confirms that patients already receiving treatment can continue.

NICE Guidance: Pegzilarginase for Arginase-1 Deficiency

NICE has published guidance recommending pegzilarginase (Loargys) for treating arginase-1 deficiency in individuals aged 2 years and over. The guidance includes evidence-based recommendations and details a commercial access agreement for the treatment.

EU Closes State Aid Investigation for Peugeot Investment

The European Commission has closed its formal investigation into State aid concerning a regional investment project for Peugeot Citroën Automóviles España, S.A. The closure follows a withdrawal by the Member State, Spain, and relates to aid under Articles 107 to 109 of the TFEU.

EU Commission Approves Apollo Funds / Lecta Merger

The European Commission has issued a decision granting non-opposition to the proposed concentration between Apollo Funds and Lecta. This decision, made under the EU Merger Regulation, signifies the Commission's approval of the acquisition.

EU Merger Control: Neuberger/Ares/Onex/Founder/Ryan Decision

The European Commission has published its decision on merger case M.12322, concerning the acquisition of joint control of Ryan by Neuberger, Ares, Onex, and G. Brint Ryan. The Commission has decided not to oppose the notified operation, declaring it compatible with the internal market.

Merger Decision M.12287 TPG / Vitality / SoftBank / Cambridge Mobile Telematics

The European Commission has approved the proposed concentration in Case M.12287, involving TPG, Vitality, SoftBank, and Cambridge Mobile Telematics. The decision, adopted under Article 6(1)(b) of the Merger Regulation, signifies non-opposition to the joint control acquisition.