健康发展与政策研究2024，Vol.27Issue(5)：417-424,431,9.DOI:10.12458/HDPR.202406009
药品国际监管协调的发展现状研究与思考
Research and reflection on the development of international regulatory harmonization of pharmaceutics
李壮琪 1许倩 1张姝婷 1刘宝1
作者信息
- 1. 复旦大学公共卫生学院,国家卫生健康委员会卫生技术评估重点实验室,上海 200433
- 折叠
摘要
Abstract
In the context of global health,strengthening regulatory harmonization of pharmaceutics across countries and regions has become increasingly important and necessary.This study employs a literature review to analyze the key issues facing global health development,explores global practices in drug regulatory coordination and reliance,and examines the current status of China's participation in international regulatory harmonization.It aims to propose recommendations for promoting international regulatory harmonization of pharmaceutics at both global and national levels.Currently,WHO has promoted the global drug regulatory coordination,and international organizations such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) have established international regulatory consensus.Mutual recognition of drug inspections has been largely established between regulatory agencies in developed countries,such as those in the United States,the European Union,the United Kingdom,Canada,and Australia.Regulatory agencies in Africa,Latin America,and the Caribbean,on the other hand,often rely unilaterally on the regulatory decisions made by the United States and Europe.China's National Medical Products Administration (NMPA) has joined international regulatory coordination organizations,including ICH,PIC/S,and ICMRA (International Coalition of Medicines Regulatory Authorities),and has established bilateral cooperation with regulators in more than 50 countries and regions.In the future,agencies and organizations should work collaboratively to promote international regulatory coordination,facilitate the global sharing of regulatory resources from developed and high-income countries,and ensure that regulatory decisions are effectively shared worldwide.NMPA should advance the mutual recognition with counterpart agencies in countries with more well-established regulatory systems and encourage the creation of regional drug regulatory cooperation alliances.This will contribute China's efforts toward addressing the imbalances in global health development.关键词
监管协调/监管互认/监管依赖Key words
regulatory harmonization/mutual recognition/regulatory reliance分类
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李壮琪,许倩,张姝婷,刘宝..药品国际监管协调的发展现状研究与思考[J].健康发展与政策研究,2024,27(5):417-424,431,9.
