WHO INFORME 58 - ABRIL 2025 - TRS 1060
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WHO TRS 1060 INFORME 58
Annex 1
Guidelines and guidance texts adopted by the Expert Committee on Specifications for
Pharmaceutical Preparations
Guidelines and guidance texts adopted by the Expert Committee on Specifications for
Pharmaceutical Preparations
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
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
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
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
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
Guidance for the graphic representation of chemical structures of pharmaceutical
substances in the publications of International Nonproprietary Names and
The International Pharmacopoeia
WHO TRS 1060 INFORME 58