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Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products China Pharmaceutical Guidebook Series (4) (4th edition)

Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:
A Guidebook of Registration Application for Imported Biological Products
China Pharmaceutical Guidebook Series (4) (4th edition)

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Price $750.00
Meta Description 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
Publisher Access China
Date of Report Jan 5, 2011
Quick Overview
Executive 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. Just for this reason, the requirements of materials and clinical trials for registration application of biopharmaceuticals stipulated by the Chinese pharmaceutical authority are far from systematic and uniform.

In China, the pharmaceutical authority ----- the SFDA (State Food and Drug Administration, China) divided the biopharmaceuticals for registration application into two classifications, i.e. the therapeutic biological products and the prophylactic biological products. However, in the classification of therapeutic biological products, the SFDA does not provide the uniform requirements of materials and clinical trials for application of biological products for the gene therapy, the somatic cell therapy and the allergic therapy, but stipulates the other guidelines for them respectively. These guidelines provide only a common principle for them because of their diversity and complexity.

This is the fourth guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of SFDA’s requirements for materials and clinical trials of registration application and approval for imported biological products. This guidebook will introduce SFDA’s 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.

The SFDA stipulated not only the classification of product registration but also the requirements of material items and clinical trials for various categorical biopharmaceuticals in order to administer the registration application of theirs. For every categorical biopharmaceuticals, to understand the classification of product registration only is the first step for a registration application of biological products, because applicant must file the application in accordance with the classification of biological product registration. The SFDA collected all materials submission for registration application of biological products into various items and preceded the ordinal numeral for every material item, moreover, every item includes many sub-items. When an application is filed, the SFDA will request applicant to submit the materials for registration application of biological products of various categories in accordance with the material item’s ordinal numeral. Therefore, to understand the material items is the second step for registration application of biological products. The requirements of material items for registration application of biological products are introduced 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 registration application of biological products stipulated by the SFDA. The explanatory notes further explain the requirements of material items for various categorical biological products. To understand the requirements for material items is a core for registration application of biological products. The application of imported biological products must accord with the material items prescribed by the form of material items and the explanatory notes to submit materials. In general, the requirements of clinical trial for registration application of biological products are two parts, i.e. the general requirements of clinical trial and the special requirements of clinical trial for imported biological products. The application of imported biological products must accord with not only the general requirements of clinical trial but also the special requirements of clinical trial for imported biological products. The application of biological products for the gene therapy, the somatic cell therapy and the allergic therapy must follow up the provisions introduced in the Chapter 10, 11, and 12 respectively.

The guidebook concludes in chapter 13 by highlighting the significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their biopharmaceuticals registration in China. Last, the appendices in chapter 14 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 registration application of imported biological products. For the detailed pathway and procedure for application and approval of imported biological products, 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
? 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 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 Contents
Table of Contents
Table of Contents 2
Preface 4
Chapter 1. Introduction 7
Part 1. Therapeutic Biological Products 9
Chapter 2. Classification of Therapeutic Biological Product
Registration 9
Chapter 3. Material Items for Application of Therapeutic Biological
Product Registration 11
3.1. Comprehensive Materials 12
3.2. Research Materials of Pharmaceutics 14
3.3. Research Materials of Pharmacology and Toxicology 17
3.4. Materials of Clinical Investigation 19
3.5. Miscellaneous 20
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 24
Chapter 5. Requirements of Clinical Trial for Application of
Therapeutic Biological Product Registration 29
5.1. General Requirements of Clinical Trial 29
5.2?Special Requirements of Clinical Trial for Imported
Therapeutic Biological Products 30
Part 2. Prophylactic Biological Products 31
Chapter 6. Classification of Prophylactic Biological Product
Registration 31
Chapter 7. Material Items for Application of Prophylactic Biological
Product Registration 33
7.1. Comprehensive Materials 34
7.2. Summary and Evaluation of Research Results 36
7.3. Research Materials of Bacterial (Toxic) Seeds for Production Use 36
7.4. Research Materials of Cell Matrix for Production Use 37
7.5. Research Materials of Production Technique 38
7.6. Experimental Materials for Quality Study 39
7.7. Regulation Draft of Production and Assay, Drafting Explanation
of Regulation, Relevant Literature. 40
7.8. Records of Production and Assay for Samples to
Apply for Clinical Trial 40
7.9. Research Materials of Initial Stability Study 40
7.11. Plan and Scheme for Clinical Trial. 40
7.12. Summary of Pre-clinical Investigation 40
7.13. Summary of Relevant Literature for Clinical Trial. 40
7.14. Clinical Trial Reports, Draft of Informed Consent Form,
Approval Letter of Ethics Committee 41
7.15.Working Summary of Improving Production Technique
and Quality Standard, Experimental Materials of Pharmacological and
Toxicological Studies during Clinical Trials 41
7.16. Research Materials for Determining Preservation Condition
and Effective Life of Vaccines. 41
7.17. Modified Contents and Basis for Reviewed Regulation
of Production and Assay. 41
7.18. Records of Production and Assay for 3 Successive Batches
of Trial Products. 41
Chapter 8. Requirements of Material Items for Application of
Prophylactic Biological Product Registration 42
8.1. The Form of Material Items 42
8.2. The Explanatory Notes of Material Items 44
Chapter 9. Requirements of Clinical Trial for Application of
Prophylactic Biological Product Registration 46
9.1. General Requirements of Clinical Trial 46
9.2. Special Requirements of Clinical Trial for Imported
Prophylactic Biological Products 47
Part 3. Biological Products for Gene Therapy and Somatic Cell
Therapy 48
Chapter 10. Guideline for Application of Biological Products for Gene
Therapy 48
10.1. Comprehensive Materials 49
10.2. Research Contents for Project and Quality Control for Product 51
10.3. Clinical Investigations for Research Project and Product 57
Chapter 11. Guideline for Application of Biological Products for
Somatic Cell Therapy 60
11.1. Comprehensive Materials 62
11.2. Quality Control for Product 63
11.3. Clinical Investigations…………………………………………………..66
Part 4. Biological Products for Allergic Therapy 70
Chapter 12. Guideline for Application of Biological Products for
Allergic Therapy 70
12.1. Quality Control for Products 70
12.2. Requirements for Pre-clinical Investigation 76
12.3. Requirements for Clinical Trial 77
Chapter 13. Conclusion 78
Chapter 14. Appendices 81
14.1. The Drug Administration Law of the People’s Republic of China 81
14.2. The Regulations for Implementation of the Drug Administration
Law of the People’s Republic of China 108
14.3. The Good Clinical Practice of Pharmaceutical Products 135
14.4. The Good Manufacturing Practice for Pharmaceutical Products 155
14.5. Form of Registration Application for Imported Drug 174
14.6. References 179
14.7. Resources 180
14.8. Author’s Biography 181
14.9. Company’s Description 182





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