Global Drug Standards Under Review:

London, UK – October 3, 2025

A significant step in safeguarding Global Drug Standards and combating antimicrobial resistance was taken today with the release of the World Health Organization’s (WHO) quarterly publication, WHO Drug Information, Volume 39, No. 3. The bulletin—a critical resource for regulatory bodies, pharmacists, and medical professionals worldwide—includes a key focus on life-saving antimicrobials, most notably featuring Consultation Documents for the powerful antibiotic, Cefiderocol.

The release emphasizes WHO’s ongoing efforts to ensure the quality, safety, and appropriate use of medicines, particularly those crucial in treating drug-resistant infections. The inclusion of draft International Pharmacopoeia (IP) monographs is a process that solicits feedback before setting global manufacturing and quality control standards.

Headline Points

 * Release Date: The WHO Drug Information, Volume 39, No. 3, was published on October 3, 2025, providing the latest global updates on pharmaceutical quality and nomenclature.

 * Antibiotic Focus: Key consultation documents were released for Cefiderocol (Cefiderocol sulfate tosilate and Cefiderocol powder for concentrate for solution for infusion), a crucial antibiotic used against multi-drug-resistant Gram-negative bacteria.

 * Quality Standards: The bulletin includes draft revisions of International Pharmacopoeia (IP) chapters, notably on the determination of diethylene glycol and ethylene glycol in oral liquid preparations—a critical update following recent global medicine contamination incidents.

 * Nomenclature Updates: The issue concludes with the International Nonproprietary Names (INN) List – Recommended INN List No. 94, which provides standardized global names for new pharmaceutical substances.

 * Policy & Classification: The document provides updates on the Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD) classification, vital for drug utilization research and management.

Cefiderocol: The Global Resistance Fighter Under Review

The highlight of the third volume for 2025 is the inclusion of consultation documents for Cefiderocol. This is not merely a technical inclusion but a strategic move by the WHO to establish global quality specifications for a drug that stands as a last line of defence against some of the most challenging hospital-acquired infections.

Cefiderocol is a novel siderophore cephalosporin—a class of antibiotics—approved for treating infections due to highly drug-resistant Gram-negative bacteria, including organisms like Acinetobacter baumannii and Pseudomonas aeruginosa that are often resistant to multiple other antibiotics. The drug’s unique mechanism allows it to essentially “hijack” the bacteria’s iron transport system to gain entry, making it an indispensable tool in the fight against Antimicrobial Resistance (AMR).

By publishing these draft monographs, the WHO is taking steps to ensure that the manufacturing quality of Cefiderocol and its formulations—such as Cefiderocol sulfate tosilate and the powder for concentrate for solution for infusion—is rigorously defined, promoting patient safety and efficacy globally.

Combating Medicine Contamination: New IP Standards

In a direct response to global concerns over substandard and falsified medical products, the bulletin also features draft revisions to technical chapters of the International Pharmacopoeia. Specifically, it addresses the methods for the determination of diethylene glycol and ethylene glycol in liquid preparations for oral use.

These compounds are toxic industrial solvents that have tragically been found as contaminants in syrups and other oral medicines, leading to severe poisoning and death in several countries. The updated standards aim to set a definitive benchmark for analytical testing, providing regulatory agencies and manufacturers with clear, robust guidelines to prevent future contamination and protect vulnerable patient populations, particularly children.

Standardising Global Health Information

Beyond drug-specific documents, Volume 39, No. 3, concludes with the crucial Recommended International Nonproprietary Names (INN) List No. 94. INNs are unique, globally recognized names for pharmaceutical substances, ensuring clear identification and communication among healthcare professionals and regulatory bodies across different languages and countries.

Furthermore, the bulletin provides updates to the Anatomical Therapeutic Chemical (ATC) Classification and Defined Daily Dose (DDD) classifications. These standardized tools are fundamental for monitoring and comparing drug consumption patterns worldwide, informing public health policies, and tracking the use of medicines on WHO’s Essential Medicines Lists. The technical and policy updates contained within this bulletin collectively reinforce the WHO’s commitment to advancing global medicine standards and enhancing patient care.

The release of WHO Drug Information Volume 39, No. 3, underscores the global public health community’s vigilance in regulating essential medicines and addressing emerging crises like multi-drug resistance and medicine contamination.