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药典相关问题:世界卫生组织。

Compendial issues: WHO.

作者信息

Kopp-Kubel S

机构信息

World Health Organization, Geneva, Switzerland.

出版信息

J Parenter Sci Technol. 1992 Nov-Dec;46(6):201-5.

PMID:1474431
Abstract

It is important to remember that: 1. WHO is an international organization representing 182 member countries. 2. WHO has a constitutional mandate inter alia to "develop, establish and promote international standards with respect to biological, pharmaceutical and similar products." 3. Its present programme covers such activities as WHO Good Manufacturing Practices, the International Pharmacopoeia, International Nonproprietary Names (INN), WHO Certification Scheme, the Model List of Essential Drugs and many other subjects concerning safety, efficacy and quality. 4. Emphasis is now directed to the feasibility of further harmonization of requirements for drug registration and quality control having regard to the number of countries with increasing manufacturing facilities.

摘要

重要的是要记住

  1. 世界卫生组织是一个代表182个成员国的国际组织。2. 世界卫生组织的章程授权尤其包括 “制定、确立和推广关于生物、制药及类似产品的国际标准”。3. 其目前的计划涵盖诸如世界卫生组织药品生产质量管理规范、国际药典、国际非专利药品名称、世界卫生组织认证计划、基本药物示范目录以及许多其他有关安全性、有效性和质量的主题。4. 鉴于拥有越来越多生产设施的国家数量,目前重点关注进一步统一药品注册和质量控制要求的可行性。

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