WHO Drug Information 2025, vol. 39, 3 [full issue]
Loading...
Date
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
World Health Organization
Abstract
Description
[312] p.
Ensuring the quality, safety and consistent identification of medicines is a central requirement for effective regulatory systems and global public health. This issue of WHO Drug Information presents a range of technical and regulatory materials addressing pharmaceutical standards, nomenclature and classification systems relevant to medicines development and control. It brings together draft monographs proposed for inclusion in The International Pharmacopoeia, including substances such as cefiderocol and gliclazide in different pharmaceutical forms, outlining specifications for identity, purity, assay methods and impurity control using validated analytical techniques. Several of these documents are issued for public consultation, inviting input from manufacturers, regulatory authorities and other stakeholders as part of the standard-setting process. The publication also includes updates on Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD) classifications and the Recommended International Nonproprietary Names (INN) List 94, alongside revisions of analytical methods and technical chapters. By compiling consultation materials, regulatory standards and classification updates, it supports stakeholders in strengthening quality assurance, promoting harmonization and ensuring access to safe and effective medicines.
755
1060
Ensuring the quality, safety and consistent identification of medicines is a central requirement for effective regulatory systems and global public health. This issue of WHO Drug Information presents a range of technical and regulatory materials addressing pharmaceutical standards, nomenclature and classification systems relevant to medicines development and control. It brings together draft monographs proposed for inclusion in The International Pharmacopoeia, including substances such as cefiderocol and gliclazide in different pharmaceutical forms, outlining specifications for identity, purity, assay methods and impurity control using validated analytical techniques. Several of these documents are issued for public consultation, inviting input from manufacturers, regulatory authorities and other stakeholders as part of the standard-setting process. The publication also includes updates on Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD) classifications and the Recommended International Nonproprietary Names (INN) List 94, alongside revisions of analytical methods and technical chapters. By compiling consultation materials, regulatory standards and classification updates, it supports stakeholders in strengthening quality assurance, promoting harmonization and ensuring access to safe and effective medicines.
755
1060