WHO Drug Information Vol. 32, No. 3, 2018 - Recommended International Nonproprietary Names, List 80
(2018; 110 pages)

Abstract

The third issue for 2018 includes the following article:

Regulatory Requirements:

An assessment of Global Chemistry, Manufacturing and Controls (CMC) Regulatory Requirements in Low and Middle Income Countries

This article provides an update on the challenges to locate and interpret the regulatory requirements of many low and middle income (LMIC) countries. To address the varying regulatory requirements and promote the timely delivery of economical, high-quality, approved medicines for use in LMICs, a global health partnership has created a publicly available CMC regulatory database that covers 75 LMICs.

The Consultation documents section includes a proposal of revision for the International Pharmacopoeia regarding the Limit Test for Heavy Metals. Two guidelines are also proposed for revision “Guidelines on Validation, Appendix 4, Analytical Method Validation” and Guidelines on Validation, Appendix 6, Qualification”. These and other WHO working documents are available for comment at: http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects

Issue 3 concludes with List N° 80 of recommended International Nonproprietary Names (INN) for Pharmaceutical Substances.

 
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