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Journal of Chinese Pharmaceutical Sciences ›› 2015, Vol. 24 ›› Issue (3): 185-191.DOI: 10.5246/jcps.2015.03.023

• Original articles • Previous Articles     Next Articles

Impact of GMP on pharmaceutical industry in China based on indicator system evaluation

Zhe Chen1, Menglu Qi1, Guoqing Ye2, Haopeng Qu3, Bin Jiang1,4*   

  1. 1. Department of Administrative and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191, China
    2. China Food and Drug Administration, Beijing 100053, China
    3. Beijing Food and Drug Administration, Beijing 100053, China
    4. International Research Center for Medicinal Administration, Peking University, Beijing 100191, China
  • Received:2014-05-10 Revised:2014-06-02 Online:2015-03-29 Published:2015-01-10
  • Contact: Tel.: 86-10-82801701-233
  • Supported by:
    National Social Science Fund (Grant No. 13BGL141).

Abstract:

To evaluate the impact of GMP on Chinese pharmaceutical industry in a quantitative system, we referred to theories on policy evaluation and industrial organization, and conducted literature review, key person interview, multi­round Delphi and field investigation. We set up the principles to construct our indicator system, reviewed based on the policy objectives of the new GMP for drugs systematically, and analysed the influence path of the new GMP for pharmaceutical manufacturers. We proposed a three-dimensional “structure­conduct­performance” evaluation indicator system. Our evaluation indicator system is accepted by experts and relevant personnel, indicating the three-dimensional evaluation indicator system is feasible to evaluate the impact of the new GMP in Chinese pharmaceutical industry.

Key words: GMP, Pharmaceutical industry, Indicator system, Structure­conduct­performance

CLC Number: 

Supporting: