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  4. > China Pharmaceutical Guidebook Series (4) 2013 Edition - 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 M

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 fourth 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 Food and Drug Administration (hereafter called CFDA) requests applicant to submit complicate and reliable materials for application of medicine registration. The CFDA 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 CFDA 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 CFDA 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 CFDA. 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 CFDA collected all materials for application of traditional Chinese medicine and natural medicine registration into four categories and 33 items, i.e. the summary 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 CFDA provides the detailed explanations for many material items and precedes the ordinal numeral for each material item. When an application is filed, the CFDA 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 CFDA. 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 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 Implementation of the Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Form of Registration Application for Imported Drug, references, 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 CFDA (China 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 Form of Registration Application for Imported Drug, and so on.

Table Of Contents

China Pharmaceutical Guidebook Series (4) 2013 Edition - 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 M
Table of Contents
Table of Contents.1
Preface.2
Chapter 1. Introduction.5
Chapter 2. Classification of Medicine Registration.8
2.1. Definitions..8
2.2. Classification of Medicine Registration..9
Chapter 3. Material Items for Application of Medicine Registration.12
3.1. Summary Materials.13
3.2. Research Materials of Pharmaceutics.15
3.3. Research Materials of Pharmacology and Toxicology.17
3.4. Materials of Clinical Investigation.19
Chapter 4. Requirements of Material Items for Application of Medicine Registration.21
4.1. Definitions..21
4.2. The Form of Material Items.22
4.3. The Explanatory Notes of Material Items.24
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.63
7.3. The Good Clinical Practice of Pharmaceutical Products.90
7.4. Form of Registration Application for Imported Drug.111
7.5. References.116
7.6. Company's Description.117

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