从严格监管机构到世卫组织列出的机构的范式转变。

IF 1 Q4 PHARMACOLOGY & PHARMACY

Annales pharmaceutiques francaises Pub Date : 2025-04-01 DOI:10.1016/j.pharma.2025.03.006

Valérie Faillat

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引用次数: 0

摘要

监管体系在保证卫生产品的质量、安全和功效方面发挥着关键作用。经过20多年努力提高装备较差的国家监管机构的监管能力，从严格监管机构（sra）的概念向世卫组织列出的监管机构（wla）的转变代表了全球卫生生态系统的重大范式转变。本综述旨在更好地理解这一演变，并澄清作为该框架长期成功的组成部分的WLA概念。

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The paradigm shift from Stringent Regulatory Authorities to WHO-Listed Authorities.

Regulatory systems play a key role in assuring the quality, safety, and efficacy of health products. After more than 20 years of efforts on regulatory capacity improvement of the less-equipped National Regulatory Authorities, the transition from the concept of Stringent Regulatory Authorities (SRAs) to WHO-Listed Authorities (WLAs) represents a significant paradigm shift in global health ecosystem. This review aims to provide a better understanding of this evolution and to clarify the WLA concept, as a component for the long-term success of this framework.

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来源期刊

Annales pharmaceutiques francaises PHARMACOLOGY & PHARMACY-

CiteScore

1.70

自引率

7.70%

发文量

期刊介绍： This journal proposes a scientific information validated and indexed to be informed about the last research works in all the domains interesting the pharmacy. The original works, general reviews, the focusing, the brief notes, subjected by the best academics and the professionals, propose a synthetic approach of the last progress accomplished in the concerned sectors. The thematic Sessions and the – life of the Academy – resume the communications which, presented in front of the national Academy of pharmacy, are in the heart of the current events.