中国药房2012，Vol.23Issue(37)：3469-3471,3.DOI:10.6039/j.issn.1001-0408.2012.37.05
英国药品质量受权人制度对我国的启示
Enlightenment of British Pharmaceutical Qualified Person System on China
樊迪1
作者信息
- 1. 中国药科大学高等职业技术学院,南京211198
- 折叠
摘要
Abstract
OBJECTIVE: To learn from the British pharmaceutical qualified person system (PQPS), and to provide suggestions on the construction of our system. METHODS: Through analyzing British PQPS, suggestions were put forward for the improvement of the system in China to resolve the problems of the system, including enterprise gave little attention to the system and took passivity to set relevant post; there was absence of standard selection and check criteria; the legal responsibility of pharmaceutical qualified person and legal person were not clear; independent character of pharmaceutical qualified person should be further enhanced. RESULTS & CONCLUSIONS: Drawing lessons from British experience, the pharmaceutical qualified person access system and check-up system are established through the implementation of pharmaceutical qualified person registration system, drug supervisory board is set up and relevant laws and regulations are improved so as to strengthen the management of pharmaceutical qualified person.关键词
英国/药品质量受权人/注册制度/启示Key words
Britain/ Pharmaceutical qualified person/ Registration system/ Enlightenment分类
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樊迪..英国药品质量受权人制度对我国的启示[J].中国药房,2012,23(37):3469-3471,3.
