WHO INFORME 58 - TRS 1060 - 2025
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WHO I58 TRS 1060 2025
Annex 1
WHO I58 A1 TRS 1060 2025
Guidelines and guidance texts adopted by the Expert Committee on Specifications for
Pharmaceutical Preparations ... 81
Pharmaceutical Preparations ... 81
Annex 2
WHO I58 A2 TRS 1060 2025
WHO good practice considerations for the prevention and control of nitrosamines in
pharmaceutical products ... 99
Annex 3
WHO I58 A3 TRS 1060 2025
WHO good manufacturing practices for excipients used in pharmaceutical products ...123
Annex 4
WHO I58 A4 TRS 1060 2025
Good practices for blood establishments ... 177
Annex 5
WHO I58 A5 TRS 1060 2025
WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO
Model List of Essential Medicines immediate-release, solid oral dosage forms ... 293
Annex 6
WHO I58 A6 TRS 1060 2025
Guideline on bioanalytical method validation and study sample analysis ... 307
Annex 7
WHO I58 A7 TRS 1060 2025
Good practices of national regulatory authorities in implementing the collaborative
registration procedures for medical products ... 363
Annex 8
WHO I58 A8 TRS 1060 2025
Collaborative registration procedure between WHO and national regulatory
authorities in the assessment and accelerated national registration of
WHO-prequalified vector control products ... 427
Annex 9
WHO I58 A9 TRS 1060 2025
Guidance for the graphic representation of chemical structures of pharmaceutical
substances in the publications of International Nonproprietary Names and
The International Pharmacopoeia ... 467
