Ref. WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-eight report. Geneva: World Health Organization; 2025 (WHO Technical Report Series, No. 1060). Licence: CC BY-NC-SA 3.0 IGO.
Dear friends,
The WHO has just published the 58th report of the Expert Committee on Specifications for Pharmaceutical Preparations, of interest for those engaged in technical and regulatory activities, e.g. audits/inspections, marketing authorization, vigilance, procurement, field surveys of quality of medicines etc
The report is heavy, but you can access it online here: WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-eight report
It covers topics such as the selection & use of essential medicines; post-market surveillance; quality control; International Pharmacopoeia; the WHO model quality assurance system for procurement agencies; an update on the framework of WHO-listed authorities; the development of paediatric medicines; a proposal to update multisource (generic) pharmaceutical products, etc. Moreover, some annexes can be of interest for some among us:
Annex 1 Guidelines and guidance texts adopted by the Expert Committee
Annex 2 WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products
Annex 3 WHO good manufacturing practices for excipients used in pharmaceutical products
Annex 4 Good practices for blood establishments
Annex 5 WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
Annex 6 Guideline on bioanalytical method validation and study sample analysis
Annex 7 Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products
Annex 8 Collaborative registration procedure between WHO and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified vector control products
Annex 9 Guidance for the graphic representation of chemical structures of pharmaceutical substances in the publications of International Nonproprietary Names and The International Pharmacopoeia
Please share with any other concerned colleagues - and enjoy the weekend!
Raffaella