This issue of WHO Drug Information, WHO's quarterly bulletin on medicines development, regulation, quality and safety, opens with a peer-contributed article on thin-layer chromatography as a low-cost quality-control tool in the fight against substandard and falsified medicines, drawing on WHO's External Quality Assurance Assessment Scheme findings and case studies including the 2006 Panama diethylene glycol poisoning incident. The issue then presents four draft International Pharmacopoeia (Ph.Int.) consultation monographs covering tenofovir alafenamide hemifumarate, diethylcarbamazine tablets, and two cefiderocol formulations, followed by temporary and final ATC/DDD classification updates from the WHO International Working Group for Drug Statistics Methodology. The issue concludes with the large trilingual Proposed International Nonproprietary Names (INN) List 134, covering hundreds of new proposed drug names spanning small molecules, biologics, gene and cell therapies, and radiopharmaceuticals.
Key Insights
Lead article: "Thin-Layer Chromatography: A Valuable Tool in the Fight Against Substandard/Falsified Medicines," authored by researchers from North-West University's Centre of Excellence for Pharmaceutical Sciences, South Africa
WHO estimates that 10.5% of medicines in low- and middle-income countries are substandard or falsified, with regional data cited for Nigeria, Ghana, DR Congo and Mongolia
References the 2006 Panama diethylene glycol poisoning case and 2024 WHO Medical Product Alerts on falsified and contaminated propylene glycol
WHO External Quality Assurance Assessment Scheme (EQAAS) Phase 11 findings highlight proficiency gaps in thin-layer chromatography among national quality control laboratories
Draft Ph.Int. monograph published for tenofovir alafenamide hemifumarate, an antiretroviral, marking the first publicly available quality standard for this active pharmaceutical ingredient
Draft Ph.Int. monographs also published for diethylcarbamazine tablets (antifilarial) and two cefiderocol formulations (a reserve-group antibacterial)
ATC/DDD Classification (Temporary) changes agreed October 2025, open for objections until 1 February 2026
ATC/DDD Classification (Final) changes agreed April 2025, to be included in the January 2026 ATC/DDD Index, including new codes for oncology biologics such as daratumumab, pembrolizumab and nivolumab, and for chikungunya vaccines
Proposed INN List 134 covers hundreds of new proposed international nonproprietary names for pharmaceutical substances, published in Latin, English, French and Spanish
Covers pharmaceutical quality control, medicines regulation and regulatory harmonization, drug nomenclature, and pharmacoepidemiology and drug utilization statistics
