Regulations and Guidelines Should Be Strengthened Urgently for Re-evaluation on Post-marketing Medicines in China

This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on post- marketing surveillance （also named pharmacovigilance）, therefore, their...

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Bibliographic Details
Published in:Chinese journal of integrative medicine 2013-07, Vol.19 (7), p.483-487
Main Author: 谢雁鸣 田峰
Format: Article
Language:English
Subjects:
China
Developed Countries
Drug and Narcotic Control
Feature Article
Guidelines as Topic
Medicine
Medicine & Public Health
Product Surveillance, Postmarketing
上市
中国
发达国家
法律法规
药品
规例
评价
调节系统
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Summary:This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on post- marketing surveillance （also named pharmacovigilance）, therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China＇s actual conditions, and cooperating with multidisciplinary researchers.
ISSN:1672-0415
1993-0402
DOI:10.1007/s11655-013-1500-0