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Monday, 16 November 2015

China Pharmaceutical Guidebook Series Market Industry 2015 Market Size, Share, trends and Forecast 2015

This is the third guidebook of the China Pharmaceutical Guidebook Series. It provides a detailed introduction of CFDAs requirements for materials and clinical trials of registration application and approval for imported biological products.

 
Summary
The biopharmaceutical industry is one of the burgeoning industries. In the field of biopharmaceuticals, vast knowledge awaits people to explore. The biopharmaceuticals are diversified and complex. In China, the development of biopharmaceutical industry is far behind the developed countries. The requirements of materials and clinical trials for registration application of biopharmaceuticals stipulated by the Chinese pharmaceutical authority are far from systematic and harmonized. 
 

 This is the third guidebook of the China Pharmaceutical Guidebook Series. It provides a detailed introduction of SFDAs requirements for materials and clinical trials of registration application and approval for imported biological products. This guidebook will introduce SFDAs requirements for materials and clinical trials of registration application for imported biological products in four parts and twelve chapters according to the existing a serial of regulations and guidelines. The Part I provides an introduction of the requirements for materials and clinical trials of registration application for imported therapeutic biological products. The Part II introduces the requirements for materials and clinical trials of registration application for imported prophylactic biological products. The Part III addresses the requirements for materials and clinical trials of registration application for imported gene therapeutic biological products and somatic cell therapeutic biological products. The Part IV addresses the requirements for materials and clinical trials of registration application for imported allergic therapeutic biological products.
 
Scope
This is the third guidebook of the China Pharmaceutical Guidebook Series. It provides a detailed introduction of CFDAs requirements for materials and clinical trials of registration application and approval for imported biological products, from the requirements for materials and clinical trials of registration application for imported therapeutic biological products, the requirements for materials and clinical trials of registration application for imported prophylactic biological products, the requirements for materials and clinical trials of registration application for imported gene therapeutic biological products and somatic cell therapeutic biological products to the requirements for materials and clinical trials of registration application for imported allergic therapeutic biological products.
 
Reason 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

The classification of biological product registration
The material items for application of biological product registration
The requirements of material items for application of biological product registration
The requirements of clinical trial for application of biological product registration
The guideline for application of biological products for human gene therapy
The guideline for application of biological products for somatic cell therapy
The guideline for application of biological products for allergic therapy
The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their biopharmaceuticals registration in China.
Many useful resources of law and regulations, including the Drug Administration Law of the Peoples Republic of China, the Regulations for Implementation of the Drug Administration Law of the Peoples Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Form of Registration Application for Imported Drug, and so on.
                
 Table Of Content 

Table of Contents.1
Preface.4
 
Chapter 1. Introduction.7
 
Part 1.  Therapeutic Biological Products.10
 
Chapter 2. Classification of Therapeutic Biological Product Registration.10
 
Chapter 3.  Material Items for Application of Therapeutic Biological Product 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
3.5. Miscellaneous.20
 
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Chapter 4. Requirements of Material Items for Application of Therapeutic Biological Product Registration.21
4.1. The Form of Material Items.21
4.2. The Explanatory Notes of Material Items.25
 
Chapter 5. Requirements of Clinical Trial for Application of Therapeutic Biological Product Registration.32
5.1. General Requirements of Clinical Trial.32
5.2. Special Requirements of Clinical Trial for Imported Therapeutic Biological Products.33
 
Part 2.  Prophylactic Biological Products.34
 
Chapter 6. Classification of Prophylactic Biological Product Registration.34
 
Chapter 7. Material Items for Application of Prophylactic Biological Product Registration.37
7.1. Summary Materials.37
7.2. Summary and Evaluation of Research Results.39
7.3. Research Materials of Bacterial (Toxic) Strains for Production Use.39
7.4. Research Materials of Cell Matrix for Production Use.40


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