Executive SummaryThe traditional medicines in Orient, especially, the traditional Chinese medicines are always regarded by occidental as mysterious medicines. Until today not only the chemical composition of traditional Chinese medicines almost can not been expressed by a precise chemical structural formula, but also the indications of the majority of traditional Chinese medicines still can not been clearly described by the modern medical terminologies. How the Chinese drug authorities to administer the registration application for such mysterious traditional Chinese medicines' This is the third guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of the Chinese pharmaceutical authorities' requirements for materials and clinical trials of application and approval for imported traditional Chinese medicine. The Chinese pharmaceutical authorities collect the traditional Chinese medicines and the natural medicines into a category for registration application. Therefore, this guidebook will provide not only the introduction for registration application of imported traditional Chinese medicines but for the natural medicines.In China, like in other Western countries, the pharmaceutical authority ----- China State Food and Drug Administration (hereafter called SFDA) requests applicant to submit complicate and reliable materials for application of medicine registration. The SFDA stipulated the classification of medicine registration in order to administer the application of traditional Chinese medicine and natural medicine registration. At the same time, the SFDA collected the materials for application of traditional Chinese medicine and natural medicine registration into four categories and 33 items in accordance with various medicine categories. When an application of traditional Chinese medicine and natural medicine registration is filed, the SFDA will request applicant to not only submit designated material items in accordance with prescribed category of traditional Chinese medicines and natural medicines to apply for registration, but also conduct the clinical trials for certain categorical traditional Chinese medicines and natural medicines.Chapter 2 provides an overview of the classification of medicine registration that is formulated by the SFDA. To understand this classification of medicine registration only is the first step for an application of traditional Chinese medicine and natural medicine registration, because applicant must file the application in accordance with this classification of medicine registration. Chapter 3 addresses the material items for application of traditional Chinese medicine and natural medicine registration. The SFDA collected all materials for application of traditional Chinese medicine and natural medicine registration into four categories and 33 items, i.e. 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 traditional Chinese medicine and natural medicine 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 traditional Chinese medicine and natural medicine 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 traditional Chinese medicine and natural medicine registration. Chapter 4 introduces the requirements of material items for application of traditional Chinese medicine and natural medicine 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 traditional Chinese medici

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China Pharmaceutical Regulation (3) - 2009 Edition
Published on May 2009
Report Summary
Executive Summary
The traditional medicines in Orient, especially, the traditional Chinese medicines are always regarded by occidental as mysterious
medicines. Until today not only the chemical composition of traditional Chinese medicines almost can not been expressed by a
precise chemical structural formula, but also the indications of the majority of traditional Chinese medicines still can not been clearly
described by the modern medical terminologies. How the Chinese drug authorities to administer the registration application for such
mysterious traditional Chinese medicines' This is the third guidebook of the China Pharmaceutical Guidebook Series. It will provide a
detailed introduction of the Chinese pharmaceutical authorities' requirements for materials and clinical trials of application and
approval for imported traditional Chinese medicine. The Chinese pharmaceutical authorities collect the traditional Chinese medicines
and the natural medicines into a category for registration application. Therefore, this guidebook will provide not only the introduction
for registration application of imported traditional Chinese medicines but for the natural medicines.
In China, like in other Western countries, the pharmaceutical authority ----- China State Food and Drug Administration (hereafter
called SFDA) requests applicant to submit complicate and reliable materials for application of medicine registration. The SFDA
stipulated the classification of medicine registration in order to administer the application of traditional Chinese medicine and natural
medicine registration. At the same time, the SFDA collected the materials for application of traditional Chinese medicine and natural
medicine registration into four categories and 33 items in accordance with various medicine categories. When an application of
traditional Chinese medicine and natural medicine registration is filed, the SFDA will request applicant to not only submit designated
material items in accordance with prescribed category of traditional Chinese medicines and natural medicines to apply for registration,
but also conduct the clinical trials for certain categorical traditional Chinese medicines and natural medicines.
Chapter 2 provides an overview of the classification of medicine registration that is formulated by the SFDA. To understand this
classification of medicine registration only is the first step for an application of traditional Chinese medicine and natural medicine
registration, because applicant must file the application in accordance with this classification of medicine registration. Chapter 3
addresses the material items for application of traditional Chinese medicine and natural medicine registration. The SFDA collected all
materials for application of traditional Chinese medicine and natural medicine registration into four categories and 33 items, i.e. 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 traditional Chinese medicine and natural medicine 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 traditional Chinese medicine and natural
medicine 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 traditional Chinese medicine and natural medicine registration. Chapter 4
introduces the requirements of material items for application of traditional Chinese medicine and natural medicine 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 traditional Chinese medicine and natural medicine registration stipulated by the SFDA. The explanatory notes
further explain the requirements of material items for various categorical traditional Chinese medicines and natural medicines. To
understand the contents of this section is a core for application of traditional Chinese medicine and natural medicine registration. The
application of imported traditional Chinese medicine and natural medicine 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 traditional Chinese medicine and natural medicine registration. There are two parts, i.e. the general requirements of
China Pharmaceutical Regulation (3) - 2009 Edition Page 1/5

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clinical trial and the special requirements of clinical trial for imported traditional Chinese medicines and natural medicines. The
guidebook concludes in chapter 6 by highlighting the significant suggestions for overseas pharmaceutical manufacturers and
producers looking to achieve a successful application for their traditional Chinese medicine and natural medicine registration in China.
Last, the appendices in chapter 7 include the Drug Administration Law of the People's Republic of China, the Regulations 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 traditional Chinese medicine and natural medicine 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.
Report Highlights
- An overview of the classification of medicine registration formulated by the SFDA (State Food and Drug Administration in China).
- The material items for application of medicine Registration.
- The requirements of material items for application of medicine registration.
- The requirements of clinical trial for application of medicine registration.
- The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application
for their traditional Chinese medicine and natural medicine 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.
Table of Content
Table of Contents 1
Preface 2
Chapter 1. Introduction 4
Chapter 2. Classification of Medicine Registration 7
2.1. Definitions 7
2.2. Classification of Medicine Registration 8
Chapter 3. Material Items for Application of Medicine Registration 11
3.1. Comprehensive Materials 12
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3.2. Research Materials of Pharmaceutics 14
3.3. Research Materials of Pharmacology and Toxicology 16
3.4. Materials of Clinical Investigation 18
Chapter 4. Requirements of Material Items for Application of Medicine Registration 20
4.1. Definitions 20
4.2. The Form of Material Items 21
Chapter 5. Requirements of Clinical Trial for Application of Medicine Registration 29
5.1. General Requirements of Clinical Trial 29
5.2. Special Requirements of Clinical Trial for Imported Medicines 31
Chapter 6 Conclusion. 32
Chapter 7. Appendices 34
7.1. The Drug Administration Law of the People's Republic of China 34
7.2. The Regulations for Implementation of the Drug Administration Law of the People's Republic of China 62
7.3. The Good Clinical Practice of Pharmaceutical Products 89
7.4. The Good Manufacturing Practice for Pharmaceutical Products 109
7.5. Form of Registration Application for Imported Drug 128
7.6. References 133
7.7. Resources 134
7.8. Author's Biography 136
7.9. Company's Description 137
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