Health products policy and standards
Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.
Working documents in public consultation
Please send any comments you may have to the responsible person indicated in the box on the first page of each working document. You will need to use the table for comments for such purpose.
- ZIDOVUDINE CAPSULES (ZIDOVUDINI CAPSULAE) (QAS/22.933)
- ZIDOVUDINE (ZIDOVUDINUM) (QAS/22.918)
- Guidance for the graphic representation of pharmaceutical substances in the publications of International Nonproprietary Names and The International Pharmacopoeia (QAS/17.726)
- Collaborative Registration procedure between the World Health Organization (WHO) and National Regulatory Authorities in the assessment and accelerated national registration of who-prequalified vector control products (QAS/24.951)
- Diethylcarbamazine Dihydrogen Citrate (QAS/21.896)
- Medicinal Oxygen (QAS/24.949)
New working documents under review for norms and standards for pharmaceuticals
for medicines quality assurance
- WHO/UNFPA condom quality assurance (QAS/19.807)
- Bioanalytical method validation and study sample analysis (QAS/23.925)
- WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products (QAS/24.943)
- WHO GMP for excipients used in pharmaceutical products - Appendix 2: List of examples of high-risk excipients (QAS/24.944)
- WHO GMP for excipients used in pharmaceutical products - Appendix 1: Risk Management in the production and control of excipients used in pharmaceutical products (QAS/24.945)
Monographs and general texts under review/revision for inclusion in The International Pharmacopoeia
for inclusion in the International Pharmacopoeia
- Estradiol Valerate and Norethisterone Enantate injection (QAS23.941)
- Tenofovir Disoproxil Fumarate (QAS/23.939)
- Ethambutol dihydrochloride disperible tablets (QAS/23.935)
- Albendazole chewable tablets (QAS/23-934)
- Efavirenz (QAS/23.928)
- Micro determination of water (QAS/23.926)
- Test for diethylene glycol and ethylene glycol in liquid preparations for oral use (QAS/23.922/Rev.1)
- Zidovudine (QAS/22.918)
- MeltingPoint (QAS22/916)
- Yttrium (90y) Silicate Injection (QAS/22.915)
- Lamivudinne and Tenofovir Disoproxil Fumarate Tablets (QAS/22.912)
- Tenofovir Disoproxil Fumarate Tablets (QAS/22.911)
- Nirmatrelvir Tablets (QAS/22.910)
- Nirmatrelvir (QAS/22.909)
- Miltefosine (QAS/21.908)
- Molnupiravir capsules (QAS/21.907/Rev.2)
- Molnupiravir (QAS/21.906/Rev.2)
- Test for 1-nitroso-4-methyl piperazine in rifampicin api or rifampicin tablets by hplc-ms/ms (QAS/21.899)
- Isoniazid Tablets (QAS/21.893/Rev.1)
- Isoniazid (QAS/21.892/Rev.1)
- Linezolid tablets (QAS/21.888/Rev.1)
- Miltefosine capsules (QAS/21.887)
- Benzathine Benzylpenicillin for Injection (QAS/21.880)
- Benzathine Benzylpenicillin Tetrahydrate (QAS/21.879)
- Ethambutol dihydrochloride (QAS/21.877)
- Gelatin (QAS/21.874)
- Ethanol, Anhydrous (QAS/21.873)
- Ethanol 96% (V/V) (QAS/21.872)
- Rifampicin (QAS/20.866)
- Linezolid (QAS/20.841/Rev.1)
- Dissolution test for solid oral dosage forms (QAS/20.837)
- Zanamivir powder for inhalation, pre-metered (QAS/20.835)
- Zanamivir (QAS/20.834)
- Albendazole Tablets (QAS/19.812/Rev.1)
- Albendazole (QAS/18.755/Rev.1)