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Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs

Published: Apr, 2014 | Pages: 121 | Publisher: Access China Management Consulting Ltd. Research
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Synopsis
This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of CFDA’s requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.	

Summary
In China, like in other Western countries, the pharmaceutical authority ----- the State Food and Drug Administration (hereinafter called as 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 summary 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 Regulations for Implementation of Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Application Form of Imported Drug Registration, 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 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 (2013 Edition) ---- Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies. 

Scope
This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of CFDA’s requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals, from the classification of drug registration, the material items for application of chemical drug registration, the requirements of clinical trial for application of chemical drug registration to the material and clinical trial requirements for application of radioactive pharmaceuticals.	

Reasons To Buy
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.

Key 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 Form of Registration Application for Imported Drug, and so on.
 Table of Contents

Table of Contents.1
Preface.2

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
6.1.Definitions.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
8.5. References.119
8.6. Company’s Description.120 

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