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| A Guidebook of Registration Application for Imported Biological Products |
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Preface
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.
l Latest Chinese Regulations for Imported Drug Registration:
A Comprehensive Guidebook for Foreign Pharmaceutical Companies
l Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:
A Guidebook of Registration Application for Imported Chemical Drugs
l Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:
A Guidebook of Registration Application for Imported Biological Products
l 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 usefulresources 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
l The classification of biological product registration
l The material items for application of biological product registration
l The requirements of material items for application of biological product registration
l The requirements of clinical trial for application of biological product registration
l The guideline for application of biological products for human gene therapy
l The guideline for application of biological products for somatic cell therapy
l The guideline for application of biological products for allergic therapy
l The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their biopharmaceuticals registration in China.
l Many usefulresources 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.
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.
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 |
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