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. In China, the process of application and approval for imported drug registration is very complex, because the Chinese pharmaceutical authorities administer and control this process by exorbitant administrative measures and regulations, moreover, these exorbitant administrative regulations are variable and lack of transparency. Therefore, a comprehensive and thorough knowledge of the latest Chinese regulations for imported drug registration has been become an essential prerequisite for overseas pharmaceutical manufacturers and producers to achieve a successful application for their products entry into the Chinese drug market. In despite of since the drug registration implemented by the Chinese pharmaceutical authorities on December 1, 2002, its regulatory regime has experienced countless changes, and become increasingly compatible with international standards, in turn, its ongoing consolidation will eventually contribute to a healthier market environment. The Chinese Pharmaceutical authority promulgated the last “Measures for the Administration of Drug Registration” on July 10 2007, and the last “Measures” entered into force since October 1, 2007. However, the practical operations for application and approval of imported drug registration have been constantlychanged, because the amendment of “Measures” is delayed. Under such circumstance, Access China Management Consulting Ltd published the China Pharmaceutical Guidebook Series: 2013 Edition. The aim of this guidebook series is to guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration. This guidebook series are composed of four guidebooks as the following.
In this guidebook series, overseas pharmaceutical manufacturers and producers can easily find out every answer that they will meet question during process of application and approval for their imported drug registration. Access China Management Consulting Ltd hopes this China Pharmaceutical Guidebook Series, based on full and accurate regulations and law, can help guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration in China.
This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of SFDA’s requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.
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Table of Contents
Table of Contents.1
Chapter 1. Introduction.5
Chapter 2. Classification of Drug Registration.7
Chapter 3. Material Items for Application of Drug Registration.9
3.1. Summary Materials.9
3.2. Research Materials of Pharmaceutics.12
3.3. Research Materials of Pharmacology and Toxicology.14
3.4. Materials of Clinical Investigation.16
Chapter 4. Requirements of Material Items for Application of Drug Registration.17
4.1. The Form of Material Items.17
4.2. The Explanatory Notes of Material Items.20
Chapter 5. Requirements of Clinical Trial for Application of Drug Registration.25
5.1. General Requirements of Clinical Trial.25
5.2. Special Requirements of Clinical Trial for Imported Drugs.28
Chapter 6. Material and Clinical Trial Requirements for Radioactive Pharmaceuticals.30
6.2．Requirements of Material Items.31
6.3．Explanatory Notes of Material Items.31
6.4．Requirements of Clinical Trial.35
Chapter 7. Conclusion.36
Chapter 8. Appendices.39
8.1. The Drug Administration Law of the People’s Republic of China.39
8.2. The Regulations for Implementation of the Drug Administration Law of the People’s Republic of China.66
8.3. The Good Clinical Practice of Pharmaceutical Products.93
8.4. Form of Registration Application for Imported Drug.114
8.6. Company’s Description.120