Study on the Construction of National Governance System in the Pharmaceutical Field
LI Feng1,2, WU Xiao-ming1*
1. School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China; 2. Center for Drug Evaluation, NMPA, Beijing 100022, China
Abstract��OBJECTIVE Drug is an important goods and materials for safeguarding people's life and health, and has special attributes different from general commodities. Drug safety concerns social stability and national security. Drug governance level is an important aspect of modernization of national governance system and capacity. This paper studies the construction of national drug governance system. METHODS By researching the domestic and foreign research achievements in the field of drug governance, this article summarizes the connotation and characteristics of national governance in the field of medicine,and the governance experience of mainstream countries and emerging countries with excellent performance in drug governance. Combining with the current situation of China, the author proposes some problems. Constructing the framework model of national drug governance system, and analyzing the constituent elements and their mutuality of the national governance system in the pharmaceutical field. RESULTS The author proposes that China��s drug governance system has the problems of fragmentation of management functions, low social participation and low regulatory efficiency. CONCLUSION Some suggestions of next stage are put forward for the modernization of China's national governance system and governance capacity in the pharmaceutical field. Through the research, China should build a unified, authoritative and efficient national drug governance system, strengthen the top-level design of the regulatory system, introduce a multi-participatory social governance model, and give play to the role of association and insurance mechanism in drug governance.
���, ������. ��������ҩƷ������ϵ�Ľ���봴��[J]. �й�ҩѧ��־, 2019, 54(2): 158-163.
LI Feng, WU Xiao-ming. Study on the Construction of National Governance System in the Pharmaceutical Field. Chinese Pharmaceutical Journal, 2019, 54(2): 158-163.
YING S N. To accelerate the development of the rule of law and modernize the country��s governance system and capacity for governance [J]. China Legal Sci(�й���ѧ), 2014,(6):40-56.
[2]
JAMES N. Rosenau.Governance without Government(û������������)[M]. Nanchang: Jiangxi People��s Publishing House,2001:10-12.
[3]
YU K P. Good Governance(����������)[M]. Beijing: Soc Sci Literature Publishing House,2000:329-330.
[4]
GERRY S, HUA X F. Governance as a theory: five arguments [J]. Int Soc Sci J(Chin Ed)(�����������ѧ��־ ���İ�), 1999,55(1):19-30.
[5]
Overview of the development of China��s pharmaceutical industry in 2017 [EB/OL]. [2018-06-20]. http://www.chyxx.com/industry/201703/504995.html.
[6]
Jacobzone, S. (2000), ��Pharmaceutical Policies in OECD Countries: Reconciling Social and Industrial Goals��, OECD Labour Market and Social Policy Occasional Papers, No. 40, OECD Publishing, Paris[EB/OL]. [2018-06-20]. http://dx.doi.org/10.1787/323807375536.
[7]
HU Y L, MU L. Beyond the linear regulatory system to build a national drug safety governance system [J]. China Food Drug Admin Magazine(�й�ʳƷҩƷ���), 2017,8(1):41-45.
[8]
LIU L. The difficulties and management of the construction of drug safety society in China [J]. Probe(̽��), 2017,(6):160-165.
[9]
SHEN W X, LIU C. On the connotation, significance and mechanism of social governance of drug safety in China [J]. Law Science Magazine(��ѧ��־), 2017, 38(11):47-56.
[10]
WANG X, ZHEN C. The history of American drug regulation and its enlightenment to China [J]. Chin J New Drugs(�й���ҩ��־), 2016, 25(8):849-854.
[11]
ZHANG R M, WANG H N, DANG H X, et al. New steps by the FDA to tighten drug safety regulations [J]. Chin Pharm J(�й�ҩѧ��־), 2015, 50(10):913-915.
[12]
EISENBERG R S. The role of the FDA in innovation policy[J]. Mich Telecomm. & Tech L. Rev, 2006,13(1):345.
[13]
PISANO D J, MANTUS D. FDA Regulatory Affairs[M]. Boca Raton:CRC Press, 2014:14-19.
[14]
COLLIER J. Book: Regulating medicines in europe: competition, expertise and public health[J]. Bmj Clin Res, 2001, 322(7295):1187-1187.
[15]
LIU C X. Overview of the scientific development of international drug regulation [J]. Drug Eval Res(ҩ�������о�), 2017, 40(8):1029-1043.
[16]
SONG X. A brief analysis of the development history and current situation of Brazilian life science industry [J]. J Latin Am Stud(���������о�), 2011,33(1):57-64,80.
[17]
SONG X D. Legal system: protection of drug production and pricing in Mexico [N]. Pharmaceutical economics(ҽҩ���ñ�), 2004-08-09(006).
[18]
LIU L. The difficulties and management of the construction of drug safety society in China[J]. Probe(̽��), 2017,(6):160-165.
[19]
ZHENG J F. The basic structure and level of national governance system[J]. Chongqing Soc Sci(��������ѧ��־), 2014,(4):18-25.
[20]
ZHANG W X. Modernization of the rule of law and state governance [J]. China Legal Sci(�й���ѧ), 2014,(4):5-27.
[21]
NIU R, LIU Y, XIANG Y F, et al. Comparative study of international experience and domestic practice in drug price negotiation [J]. Chin J Health Policy(�й����������о�), 2017, 10(6):25-32.
2019, Vol. 54 
