China Pharmaceutical regulation (2)
China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2006, sales on the Chinese drug market have reached $12 billion dollars, an increase of 3.8 fold over 1998 level. 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 of 20-25 percent per annum in next five years. China is expected to become the fifth largest drug market in the world by 2010.
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 2006, sales of imported drugs have shared one fifth 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 to 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 l atest “Measures for the Administration of Drug Registration” on July 10 2007, and the latest “Measures” will enter into force since October 1, 2007. These “Measures” provide the latest detailed requirements and procedures of application and approval for imported drug registration. Under such circumstance, Access China Management Consulting Ltd published the China Pharmaceutical Guidebook Series. 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.
●Latest Chinese Regulations for Imported Drug Registration:
A Comprehensive Guidebook for Foreign Pharmaceutical Companies
●Material and Clinical Trial Requirements of Application and Approval for Imported Drug
Registration:
A Guidebook of Registration Application for Imported Chemical Drugs
●Material and Clinical Trial Requirements of Application and Approval for Imported Drug
Registration:
A Guidebook of Registration Application for Imported Biological Products
●Material and Clinical Trial Requirements of Application and Approval for Imported Drug
Registration:
A Guidebook of Registration Application for Imported Traditional Chinese Medicines and
Natural Medicines
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. Since the publication of China Pharmaceutical Guidebook Series, many executives from overseas pharmaceutical companies have paid attention to this guidebook series, and expect to acquire latest detailed information about Chinese regulations for imported drug registration, so that Access China Management Consulting Ltd completed the third edition to contribute this latest China Pharmaceutical Guidebook Series to overseas pharmaceutical companies. In this latest China Pharmaceutical Guidebook Series, many useful resources of law and regulations, including t he Drug Administration Law of the People’s Republic of China, the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Chinese Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application for Imported Drug and so on are newly added. After have skimmed through these guidebooks, audience can clearly acquire a comprehensive and thorough knowledge of the latest Chinese regulations for 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.
Report Highlights
●An overview of the classification of drug registration formulated by the SFDA (The State Food
and Drug Administration in China).
●The material items for application of drug registration.
●The requirements of material items for application of drug registration.
●The requirements of clinical trial for application of drug registration.
●The material and clinical trial requirements for application of radioactive pharmaceuticals
●The significant suggestions for overseas pharmaceutical manufacturers and producers
looking to achieve a successful application for their chemical drug registration in China.
●Many useful resources of law and regulations, including the Drug Administration Law of the
People’s Republic of China, the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Chinese Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application for Imported Drug, and so on.
Who should buy this report?
?Companies wishing to enter a lucrative drug market in China.
?Companies interested in understanding the latest Chinese regulations on application and approval for imported drug registration.
Senior executive officers engaging regulatory and registration affairs for drugs.
Executive Summary
In China, like in other Western countries, the pharmaceutical authority ----- the SFDA requests applicant to submit complicate and reliable materials for application of drug registration. The SFDA stipulated the classification of drug registration in order to administer the application of chemical drug registration. At the same time, the SFDA collected the materials for application of chemical drug registration into four categories and 32 items in accordance with various chemical drug categories. When an application of chemical drug registration is filed, the SFDA will request applicant to not only submit designated material items in accordance with prescribed category of chemical drug to apply for registration, but also conduct the clinical trials for certain categorical chemical drugs.
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.
Chapter 2 provides an overview of the classification of drug registration that is formulated by the SFDA. To understand this classification of drug registration only is the first step for an application of chemical drug registration, because applicant must file the application in accordance with this classification of drug registration. Chapter 3 addresses the material items for application of chemical drug registration. The SFDA collected all materials for application of chemical drug registration into four categories and 32 items. There are the comprehensive materials, the research materials of pharmaceutics, the research materials of pharmacology and toxicology, and the materials of clinical investigation. For administrative requirement of chemical drug registration, the SFDA provides the detailed explanations for many material items and precedes the ordinal numeral for each material item. When an application is filed, the SFDA will request applicant to submit the materials for application of chemical drug registration of various categories in accordance with the material item’s ordinal numeral. Therefore, to understand the material items is the second step for application of chemical drug registration. Chapter 4 introduces the requirements of material items for application of chemical drug registration in terms of the form of material items and their explanatory notes. The form of material items represents the current requirements of material items for application of chemical drug registration stipulated by the SFDA. The explanatory notes further explain the requirements of material items for various categorical chemical drugs. To understand the contents of this section is a core for application of chemical drug registration. The application of imported chemical drug registration must accord with the material items prescribed by the form of material Items and the explanatory notes to submit materials. Chapter 5 addresses the requirements of clinical trial for application of chemical drug registration. There are two parts, i.e. the general requirements of clinical trial and the special requirements of clinical trial for imported chemical drug. Chapter 6 introduces the material and clinical trial requirements for application of radioactive pharmaceuticals, from the definitions, the requirements of material items, the explanatory notes of material items to the requirements of clinical trial. The guidebook concludes in chapter 7 by highlighting the significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their chemical drug registration in China. Last, the appendices in chapter 8 include the Drug Administration Law of the People’s Republic of China, the Regula tions for the Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Chinese Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application for Imported Drug, references, a useful resources of URL, author’s biography, and description of Access China Management Consulting Ltd. After have skimmed through this guidebook, audience can be clearly aware of the latest Chinese regulations on requirements of the materials and the clinical trials for application of imported chemical drug registration. For the detailed pathway and procedure for application and approval of imported drug registration, audience can learn from the first guidebook of the China Pharmaceutical Guidebook Series ---- Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies.
Table of Contents
Table of Contents (3)
Preface ............................................................................. 错误！未定义书签。
Chapter 1. Introduction ................................................... 错误！未定义书签。
Chapter 2. Classification of Drug Registration ............. 错误！未定义书签。
Chapter 3. Material Items for Application of Drug Registration错误！未定义书签。
3.1. Comprehensive Materials ..................................... 错误！未定义书签。
3.2. Research Materials of Pharmaceutics ..................错误！未定义书签。
3.3. Research Materials of Pharmacology and Toxicology错误！未定义书签。Array
3.4. Materials of Clinical Investigation ..........................错误！未定义书签。
Chapter 4. Requirements of Material Items for Application of Drug
Registration .................................................................... 错误！未定义书签。
4.1. The Form of Material Items ...................................错误！未定义书签。
4.2. The Explanatory Notes of Material Items ..............错误！未定义书签。
Chapter 5. Requirements of Clinical Trial for Application of Drug
Registration ...................................................................... 错误！未定义书签。
5.1. General Requirements of Clinical Trial .................错误！未定义书签。
5.2. Special Requirements of Clinical Trial for Imported Drugs错误！未定义书签。Chapter
6. Material and Clinical Trial Requirements for
Radioactive Pharmaceuticals ......................................... 错误！未定义书签。
6.1．Definitions ...........................................................错误！未定义书签。
6.2．Requirements of Material Items ..........................错误！未定义书签。
6.3．Explanatory Notes of Material Items ...................错误！未定义书签。
6.4．Requirements of Clinical Trial ..............................错误！未定义书签。
Chapter 7. Conclusion ..................................................... 错误！未定义书签。
Chapter 8. Appendices .................................................... 错误！未定义书签。
8.1. The Drug Administration Law of the People’s Republic of China错误！未定义书签。
8.2. The Regulations for Implementation of the Drug Administration
Law of the People’s Republic of China ......................错误！未定义书签。
8.3. The Good Clinical Practice of Pharmaceutical Products错误！未定义书签。
8.4. The Good Manufacturing Practice for Pharmaceutical Products错误！未定义书签。
8.5. Form of Registration Application for Imported Drug错误！未定义书签。
8.6. References ...........................................................错误！未定义书签。
8.7. Resources ............................................................错误！未定义书签。
8.8. Author’s Biography................................................错误！未定义书签。
8.9. Company’s Des cription .........................................错误！未定义书签。
Access China Management Consulting Ltd is a professional provider of managements and consulting services specifically designed to provide overseas clients a virtual gateway to enter the lucrative market of China. Access China is headquartered in Nanjing, Jiangsu Province, Eastern China.
At present, company provides consulting services for foreign clients as follows.
●Research of Chinese pharmaceutical industry and market;
●license transfer; registration of imported drugs and new drugs; pharmaceutical patent
applications; management of laws and regulations on pharmaceuticals;
●Consultancy on the Chinese laws, administrative regulations on pharmaceutical
administration;
●Provide analyses of feasibility for mergers and acquisitions of the existing Chinese
pharmaceutical enterprises;
●Act as agent, within a range of authorized, implement operation to purchase and merge the
existing Chinese pharmaceutical enterprises in accordance with the order of foreign investors;
●Help foreign investors make the registration of Foreign Investment Enterprises, including
Sino-foreign equity joint ventures (EJV), Sino-foreign cooperative joint ventures (CJV),wholly foreign-owned enterprises (WFOE), Representative Office;
●Provide a range of customized and standardized solutions including industry report, research
report of strategic investment, market analyses, and other subscription-based research and information on the latest development and strategies used in a variety of sectors.
Access China Management Consulting pursues the principle of "integrating resources and creating value" to contribute to foreign clients.
Access China Management Consulting Ltd,
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