This is the first
guidebook of the China Pharmaceutical Guidebook Series. It will provide a
detailed introduction of the latest Chinese regulations for imported drug
registration, and guide overseas pharmaceutical manufacturers and producers to
file the application for their imported drugs with the Chinese pharmaceutical
authorities.
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Summary
China possesses a
fourth population in the world and has one of the largest drug markets round
the world. By 2012, sales on the Chinese drug market have reached RMB
926.1billion (about US$147 billion) reported by the «2012: Report of China
Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is
estimated that it will exceed RMB 1,000 billion by 2013. A series of factors, such
as an increasingly ageing population, accelerating growth of urban population
as well as expansion of healthcare covering urban and rural, will grow the
Chinese drug market with a growth rate over 20 percent per annum in next three
years. China is expected to become the second largest drug market in the world
by 2015.
Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2012, sales of imported drugs have shared one fourth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door of a lucrative drug market for overseas pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market and seize a larger part of such drug market. To enter such a lucrative drug market, the first obstacle faced by overseas pharmaceutical manufacturers and producers is how to file the application for their imported drug registration with Chinese pharmaceutical authorities.
Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2012, sales of imported drugs have shared one fourth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door of a lucrative drug market for overseas pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market and seize a larger part of such drug market. To enter such a lucrative drug market, the first obstacle faced by overseas pharmaceutical manufacturers and producers is how to file the application for their imported drug registration with Chinese pharmaceutical authorities.
Table
Of Content
Chapter 1.
Introduction.5
Chapter 2. The
State Food and Drug Administration in China.6
2.1. SFDAs Main Responsibilities.6
2.2. SFDAs Organizational Structure..7
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Chapter 3.
General Regulations on Application and Approval for Imported Drug
Registration.13
3.1. Classification of Drugs..13
3.2. Definitions.13
3.3. General Regulations on Application and Approval for Imported Drug
Registration.17
3.3.1. Application and Approval for Imported Drugs.17
3.3.2. Application and Approval for Repackaging of Imported Drug.21
3.3.3. Supplementary Application..23
3.3.4. Re-registration..24
3.3.5. Clinical Trials.26
3.3.6. Time Limits in Drug Registration30
Chapter 4.
Application and Approval Procedures for Imported Drug Registration..33
4.1. Application and Approval Procedure for Imported Drugs33
4.2.Supplementary Application and Approval Procedure for Imported
Drugs..35
4.3.Application and Approval Procedure for Clinical Trials.37
Chapter 5.
Application Form for Imported Drug Registration.39
Chapter 6.
Conclusion..44
Chapter 7.
Appendices46
7.1. The Drug Administration Law of the Peoples Republic of China..46
7.2. The Regulations for Implementation of the Drug Administration Law of
the Peoples Republic of China..71
7.3. The Good Clinical Practice of Pharmaceutical Products95
7.4. References.115
7.5. Companys Description116
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