China Pharmaceutical Guidebook Series (4) (3rd edition)Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products : Market Research Report

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

Published by: Access China Management Consulting Ltd.

Published: Oct. 1, 2007 - 182 Pages

Table of Contents: Preface
Chapter 1. Introduction
Part 1. Therapeutic Biological Products
Chapter 2. Classification of Therapeutic Biological Product Registration
Chapter 3. Material Items for Application of Therapeutic Biological Product Registration: 3.1. Comprehensive Materials; 3.2. Research Materials of Pharmaceutics; 3.3. Research Materials of Pharmacology and Toxicology; 3.4. Materials of Clinical Investigation; 3.5. Miscellaneous
Chapter 4. Requirements of Material Items for Application of: Therapeutic Biological Product Registration; 4.1. The Form of Material Items; 4.2. The Explanatory Notes of Material Items
Chapter 5. Requirements of Clinical Trial for Application of Therapeutic Biological Product Registration: 5.1. General Requirements of Clinical Trial; 5.2 Special Requirements of Clinical Trial for Imported Therapeutic Biological Products
Part 2. Prophylactic Biological Products
Chapter 6. Classification of Prophylactic Biological Product Registration
Chapter 7. Material Items for Application of Prophylactic Biological Product Registration: 7.1. Comprehensive Materials; 7.2. Summary and Evaluation of Research Results; 7.3. Research Materials of Bacterial (Toxic) Seeds for Production Use; 7.4. Research Materials of Cell Matrix for Production Use; 7.5. Research Materials of Production Technique; 7.6. Experimental Materials for Quality Study; 7.7. Regulation Draft of Production and Assay, Drafting Explanation of Regulation, Relevant Literature.; 7.8. Records of Production and Assay for Samples to Apply for Clinical Trial; 7.9. Research Materials of Initial Stability Study; 7.11. Plan and Scheme for Clinical Trial.; 7.12. Summary of Pre-clinical Investigation; 7.13. Summary of Relevant Literature for Clinical Trial.; 7.14. Clinical Trial Reports, Draft of Informed Consent Form, Approval Letter of Ethics Committee; 7.15.Working Summary of Improving Production Technique; and Quality Standard, Experimental Materials of Pharmacological and Toxicological Studies during Clinical Trials; 7.16. Research Materials for Determining Preservation Condition and Effective Life of Vaccines.; 7.17. Modified Contents and Basis for Reviewed Regulation of Production and Assay.; 7.18. Records of Production and Assay for 3 Successive Batches of Trial Products.
Chapter 8. Requirements of Material Items for Application of Prophylactic Biological Product Registration: 8.1. The Form of Material Items; 8.2. The Explanatory Notes of Material Items
Chapter 9. Requirements of Clinical Trial for Application of Prophylactic Biological Product Registration: 9.1. General Requirements of Clinical Trial; 9.2. Special Requirements of Clinical Trial for Imported Prophylactic Biological Products
Part 3. Biological Products for Gene Therapy and Somatic Cell Therapy
Chapter 10. Guideline for Application of Biological Products for Gene Therapy: 10.1. Comprehensive Materials; 10.2. Research Contents for Project and Quality Control for Product; 10.3. Clinical Investigations for Research Project and Product
Chapter 11. Guideline for Application of Biological Products for Somatic Cell Therapy: 11.1. Comprehensive Materials; 11.2. Quality Control for Product; 11.3. Clinical Investigations
Part 4. Biological Products for Allergic Therapy
Chapter 12. Guideline for Application of Biological Products for Allergic Therapy: 12.1. Quality Control for Products; 12.2. Requirements for Pre-clinical Investigation; 12.3. Requirements for Clinical Trial
Chapter 13. Conclusion
Chapter 14. Appendices: 14.1. The Drug Administration Law of the People’s Republic of China; 14.2. The Regulations for Implementation of the Drug Administration Law of the People’s Republic of China; 14.3. The Good Clinical Practice of Pharmaceutical Products; 14.4. The Good Manufacturing Practice for Pharmaceutical Products; 14.5. Form of Registration Application for Imported Drug; 14.6. References; 14.7. Resources; 14.8. Author’s Biography; 14.9. Company’s Description

Abstract

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2006, sales on the Chinese drug market have reached $12 billion dollars, an increase of 3.8 fold over 1998 level. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate of 20-25 percent per annum in next five years. China is expected to become the fifth largest drug market in the world by 2010.

Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2006, sales of imported drugs have shared one fifth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door to a lucrative drug market for overseas pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market and seize a larger part of such drug market. To enter such a lucrative drug market, the first obstacle faced by overseas pharmaceutical manufacturers and producers is how to file the application for their imported drug registration with Chinese pharmaceutical authorities. In China, the process of application and approval for imported drug registration is very complex, because the Chinese pharmaceutical authorities administer and control this process by exorbitant administrative measures and regulations, moreover, these exorbitant administrative regulations are variable and lack of transparency. Therefore, a comprehensive and thorough knowledge of the latest Chinese regulations for imported drug registration has been become an essential prerequisite for overseas pharmaceutical manufacturers and producers to achieve a successful application for their products entry into the Chinese drug market. In despite of since the drug registration implemented by the Chinese pharmaceutical authorities on December 1, 2002, its regulatory regime has experienced countless changes, and become increasingly compatible with international standards, in turn, its ongoing consolidation will eventually contribute to a healthier market environment. The Chinese Pharmaceutical authority promulgated the latest “Measures for the Administration of Drug Registration” on July 10 2007, and the latest “Measures” will enter into force since October 1, 2007. These “Measures” provide the latest detailed requirements and procedures of application and approval for imported drug registration. Under such circumstance, Access China Management Consulting Ltd published the China Pharmaceutical Guidebook Series. The aim of this guidebook series is to guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration. This guidebook series are composed of four guidebooks as the following.

Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products
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 Medicines

In this guidebook series, overseas pharmaceutical manufacturers and producers can easily find out every answer that they will meet question during process of application and approval for their imported drug registration. Since the publication of China Pharmaceutical Guidebook Series, many executives from overseas pharmaceutical companies have paid attention to this guidebook series, and expect to acquire latest detailed information about Chinese regulations for imported drug registration, so that Access China Management Consulting Ltd completed the third edition to contribute this latest China Pharmaceutical Guidebook Series to overseas pharmaceutical companies. In this latest China Pharmaceutical Guidebook Series, 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 are newly added. After have skimmed through these guidebooks, audience can clearly acquire a comprehensive and thorough knowledge of the latest Chinese regulations for imported drug registration. Access China Management Consulting Ltd hopes this China Pharmaceutical Guidebook Series, based on full and accurate regulations and law, can help guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration in China.

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.

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China Pharmaceutical Guidebook Series (4) (3rd 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

Abstract