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Journal of Chinese Pharmaceutical Sciences ›› 2015, Vol. 24 ›› Issue (4): 257-262.DOI: 10.5246/jcps.2015.04.034

• Drug administration column • Previous Articles     Next Articles

Introduction to drug regulatory capabilities: a theory and framework

Song Yang1, Dongsheng Yang2, Xiaoyuan Zheng1, Guo Huang3, Luoluo Cong4, Bin Jiang1,5*   

  1. 1. Department of Administrative and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191, China
    2. R & D-based Pharmaceutical Association Committee, Beijing 100004, China
    3. China Food and Drug Administration, Beijing 100053, China
    4. Beijing Food and Drug Administration, Beijing 100053, China
    5. International Research Center for Medicinal Administration, Peking University Health Science Center, Beijing 100191, China
  • Received:2014-06-15 Revised:2014-09-24 Online:2015-04-28 Published:2015-02-28
  • Contact: Tel.: 86-10-82801701-233
  • Supported by:
    National Social Science Fund (Grant No. 13BGL141).

Abstract:

This article explored the definition, dimensions, and building mechanisms of drug regulatory capabilities (DRC) and their relationship with regulatory performance. Based on the theories on organizational capability and their application in public sector, interviews with officers from drug regulatory agencies and analysis of its three determinations, the DRC was defined as the follows: a learned pattern through which the drug regulatory agencies acquire, reconstruct and utilize organizational resources to protect and advance public health. DRC can be divided into different dimensions and structured as the basic capabilities and functional capabilities. This research also introduced three learning mechanisms for DRC construction, which include learning by doing, organizational learning, and exploratory learning. Finally, a qualitative case study of drug application and approval in China was conducted to explore the relationship between regulatory capabilities and performance.

Key words: Drug regulatory agency, Organizational capabilities, Drug regulatory capabilities, Regulatory performance

CLC Number: 

Supporting: