WHO Drug Information - Volume 34, No. 3

Overview

- The third issue of 2020, includes

Quality Assurance News:

• WHO External Quality Assurance Assessment Scheme Phase 9
• WHO Biowaiver Study Project for COVID-19 Outbreak: Dexamethasone Solubility Results for Biopharmaceutical Classification System

Consultation Documents:

• Dissolution Test for Solid Oral Dosage Forms. Draft proposal for revision in The International Pharmacopoeia
• WHO Biowaiver Project – Preparation for cycle IV (2021): Prioritization exercise of active pharmaceutical ingredients on the WHO Model List of Essential Medicines for solubility determination and Biopharmaceutics Classification System-based classification
• Zanamivir (Zanamivirum) – Draft proposal for inclusion in The International Pharmacopoeia
• Zanamivir powder for inhalation, pre-metered (Zanamiviri pulvis pro inhalatione) – Draft proposal for inclusion in The International Pharmacopoeia
• Powders for inhalation (pulvis ad inhalationem) - Draft proposal for inclusion in The International Pharmacopoeia
• Good Manufacturing Practices: Water for Pharmaceutical Use
• Revision of Chapter 2.1: General Identification Tests - Draft proposal for inclusion in The International Pharmacopoeia
• Policy: Evaluating and Publicly designating Regulatory Authorities as WHO Listed Authorities
• Good Regulatory Practices for Regulatory Oversight of Medical Products
• 3.6 Test for histamine-like substances (vasodepressor substances) - Draft proposal for inclusion in The International Pharmacopoeia
• Albendazole chewable tablets (albendazoli compressi manducabili) - Draft proposal for inclusion in The International Pharmacopoeia
• Good Reliance Practices in regulatory decision-making for medical products: high-level principles and considerations

- Issue 3 concludes with:

• List No. 124 – COVID-19 (Special Edition) of Proposed International Nonproprietary Names (INN) for Pharmaceutical Substances
• List No. 84 of Recommended International Nonproprietary Names (INN) for Pharmaceutical Substances.