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  4. > China Pharmaceutical Guidebook Series (3) 2013 Edition. Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products

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.

In China, the pharmaceutical regulatory 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 general principle for them because of their diversity and complexity. Just for this reason, a comprehensive and thorough knowledge of the latest Chinese regulations for imported biological product registration is particularly important for overseas pharmaceutical manufacturers and producers to achieve a successful application for their products entry into the Chinese drug market.

This is the third guidebook of the China Pharmaceutical Guidebook Series. It provides 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 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 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 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 (2013 Edition) ---- 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 Form of Registration Application for Imported Drug, and so on.

Table Of Contents

China Pharmaceutical Guidebook Series (3) 2013 Edition. Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products
Table of Contents
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
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
7.5. Research Materials of Production Technique.42
7.6. Experimental Materials for Quality Study, and Research Materials of Pre-clinical Efficacy and Safety.42
7.7. Regulation Draft of Production and Assay, Drafting Explanation of Regulation, Relevant Literature.44
7.8. Records of Production and Assay for Samples to apply for Clinical Trial.44
7.9. Research Materials of Initial Stability Study.44
7.10. The Quality Certificate of Animal used for Production, Research and Test.44
7.11. Plan and Scheme for Clinical Trial.45
7.12. Summary of Pre-clinical Investigation.45
7.13. Summary of Relevant Literature for Clinical Trial.45
7.14. Clinical Trial Reports, Draft of Informed Consent Form, Approval Letter of Ethics Committee.45
7.15. Working Summary of Improving Production Technique and Quality Standard, Experimental Materials of Pharmacological and Toxicological Studies during Clinical Trials.45
7.16. Research Materials for Determining Preservation Condition and Effective Life of Vaccines.46
7.17. Modified Contents and Basis for Reviewed Regulation of Production and Assay.46
7.18. Records of Production and Assay for 3 Successive Batches of Trial Products.46
Chapter 8. Requirements of Material Items for Application of Prophylactic Biological Product Registration.46
8.1. The Form of Material Items.47
8.2. The Explanatory Notes of Material Items.48
Chapter 9. Requirements of Clinical Trial for Application of Prophylactic Biological Product Registration.51
9.1. General Requirements of Clinical Trial.51
9.2. Special Requirements of Clinical Trial for Imported Prophylactic Biological Products.52

Part 3. Biological Products for Gene Therapy and Somatic Cell Therapy.53

Chapter 10. Guideline for Application of Biological Products for Gene Therapy.53
10.1. Summary Materials.54
10.2. Research Contents for Project and Quality Control for Product.56
10.3. Clinical Investigations for Research Project and Product.62
Chapter 11. Guideline for Application of Biological Products for Somatic Cell Therapy.65
11.1. Summary Materials.67
11.2. Quality Control for Product.68
11.3. Clinical Investigations.72

Part 4. Biological Products for Allergic Therapy.74

Chapter 12. Guideline for Application of Biological Products for Allergic Therapy.74
12.1. Quality Control for Products.75
12.2. Requirements for Pre-clinical Investigation.80
12.3. Requirements for Clinical Trial.81
Chapter 13. Conclusion.83
Chapter 14. Appendices.85
14.1. The Drug Administration Law of the People's Republic of China.85
14.2. The Regulations for Implementation of the Drug Administration Law of the People's Republic of China.113
14.3. The Good Clinical Practice of Pharmaceutical Products.140
14.4. Form of Registration Application for Imported Drug.161
14.5. References.166
14.6. Company's Description.167

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