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Reportlinker Adds China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug Registration

Wednesday, June 1, 2011 General News J E 4
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NEW YORK, June 1, 2011 /PRNewswire/ --Reportlinker.com announces that a new market research report is available in its catalogue:

China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug Registration

http://www.reportlinker.com/p0512261/-China-Pharmaceutical-Guidebook -Latest-Chinese-Regulations-for-Imported-Drug-Registration .html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Alternative_Medicine

Executive Summary

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. In July 2007, the Chinese pharmaceutical authorities promulgated the latest "Measures for the Administration of Drug Registration", 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 this China Pharmaceutical Guidebook---- Latest Chinese Regulations for Imported Drug Registration. The aim of this guidebook is to guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration. This guidebook is composed of four main parts as the following.

- A Comprehensive Guidance of Imported Drug Registration

- A Guidance of Registration Application for Imported Chemical Drugs

- A Guidance of Registration Application for Imported Biological Products

- A Guidance of Registration Application for Imported Natural Medicines and Traditional Chinese Medicines

Part I provides a comprehensive guidance of imported drug registration, which introduces an overview of the main responsibilities and organization structure of the Chinese pharmaceutical authority ---- State Food and Drug Administration (SFDA), the comprehensive regulations for imported drug registration in China, from the classification of drugs, definitions relating to application for imported drug registration, the application and approval for imported drugs and repackaging of imported drugs, the supplementary application and re-registration for imported drugs, the clinical investigation for application of imported drug registration to the time limits in drug registration, as well as the procedures of application and approval for imported drug registration, including the procedures of the initial application and approval for imported drugs, the supplementary application and approval for imported drugs, and the application and approval for clinical trials relating to imported drugs. All such knowledge in Part I is essential to achieve a successful application and approval for imported drug registration in China.

In China, like in other Western countries, the pharmaceutical authority ---- SFDA requests applicant to submit complicate and reliable materials for application of imported drug registration. Therefore, to achieve a successful application and approval for imported drug registration in China, overseas pharmaceutical manufacturers and producers must understand the more depth and detailed regulations on registration application for various imported drugs.

Part II provides a guidance of registration application for imported chemical drugs, which addresses SFDA's requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals, from the classification of drug registration formulated by the SFDA, the material items for application of chemical drug registration, the requirements of material items for application of chemical drug registration, the requirements of clinical trial for application of chemical drug registration to the material and clinical trial requirements for application of radioactive pharmaceuticals.

Part III provides a guidance 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. 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 SFDA 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 registration application of biological products for the gene therapy, the somatic cell therapy and the allergic therapy, but stipulates the other guidelines for them. Therefore, the requirements for materials and clinical trials of registration application for imported gene therapeutic biological products, imported somatic cell therapeutic biological products and imported allergic therapeutic biological products are addressed based on these guidelines. Part III addresses the requirements of material items and clinical trials for registration application of imported therapeutic biological products and prophylactic biological products, as well as the imported biological products for the gene therapy, the somatic cell therapy and the allergic therapy, from the classification of therapeutic biological product and prophylactic biological product registration formulated by the SFDA, the material items for registration application of therapeutic biological products and prophylactic biological products, the requirements of material items for registration application of therapeutic biological products and prophylactic biological products, the requirements of clinical trial for registration application of therapeutic biological products and prophylactic biological products to the guideline for registration application of biological products for human gene therapy, the guideline for registration application of biological products for somatic cell therapy, and the guideline for registration application of biological products for allergic therapy.

Part IV provides a guidance of registration application for imported natural medicines and traditional Chinese medicines. The traditional medicines in Orient, especially, the traditional Chinese medicines are always regarded by occidental as mysterious medicines. Until today not only the chemical composition of traditional Chinese medicines almost can not been expressed by a precise chemical structural formula, but also the indications of the majority of traditional Chinese medicines still can not been clearly described by the modern medical terminologies. How the Chinese pharmaceutical authorities to administer the registration application for such mysterious traditional Chinese medicines? Part IV provides a detailed introduction of the SFDA's requirements for materials and clinical trials of application and approval for imported traditional Chinese medicine. The SFDA collects the traditional Chinese medicines and the natural medicines into a category for registration application. Therefore, Part IV provides not only the introduction for registration application of the imported traditional Chinese medicines but for the natural medicines, from the classification of natural medicine and traditional Chinese medicine registration formulated by the SFDA, the material items for registration application of natural medicines and traditional Chinese medicines, the requirements of material items for registration application of natural medicines and traditional Chinese medicines to the requirements of clinical trial for registration application of natural medicines and traditional Chinese medicines.

The guidebook concludes in Part V by highlighting the significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their drug registration in China. Last, the appendices in Part VI 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.

More and more overseas pharmaceutical manufacturers and producers expect to acquire the latest detailed information about the Chinese regulations for imported drug registration. In this guidebook, 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 in China. After have skimmed through this guidebook, 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 ---- Latest Chinese Regulations for Imported Drug Registration, 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

- An overview of the main responsibilities and organization structure of the SFDA (The State Food and Drug Administration) that is current Chinese pharmaceutical authority at the central level, and takes responsible for application and approval for imported drug registration.

- The comprehensive regulations for imported drug registration in China, from the classification of drugs, definitions relating to application for imported drug registration, the application and approval for imported drugs and repackaging of imported drugs, the supplementary application and re-registration for imported drugs, the clinical investigation for application of imported drug registration to the time limits in drug registration.

- The procedures of application and approval for imported drug registration, including the procedures of the initial application and approval for imported drugs, the supplementary application and approval for imported drugs, and the application and approval for clinical trials relating to imported drugs.

- A guidance of registration application for imported chemical drugs.

- A guidance of registration application for imported biological products.

- A guidance of registration application for imported natural medicines and traditional Chinese medicines.

- The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their drug 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

EXECUTIVE SUMMAR.1

Table of Contents6

PART I. A COMPREHENSIVE GUIDANCE OF IMPORTED DRUG

REGISTRATION 11

CHAPTER I-1. INTRODUCTION 11

CHAPTER I-2. THE STATE FOOD AND DRUG ADMINISTRATION IN

CHINA 12

2.1. SFDA'S MAIN RESPONSIBILITIES 14

2.2. SFDA'S ORGANIZATION STRUCTURE 14

CHAPTER I-3. GENERAL REGULATIONS ON APPLICATION AND

APPROVAL FOR IMPORTED DRUG REGISTRATION 19

3.1. CLASSIFICATION OF DRUGS 19

3.2. DEFINITIONS 20

3.3. GENERAL REGULATIONS ON APPLICATION AND APPROVAL FOR IMPORTED

DRUG REGISTRATION 23

3.3.1. APPLICATION AND APPROVAL FOR IMPORTED DRUGS 23

3.3.2. APPLICATION AND APPROVAL FOR REPACKAGING OF IMPORTED DRUG 28

3.3.3. SUPPLEMENTARY APPLICATION 30

3.3.4. RE-REGISTRATION 31

3.3.5.CLINICAL INVESTIGATION 33

3.3.5.1.PRECLINICAL INVESTIGATION 33

3.3.5.2.CLINICAL TRIALS 34

3.3.6. TIME LIMITS IN DRUG REGISTRATION 40

CHAPTER I-4. APPLICATION AND APPROVAL PROCEDURES FOR

IMPORTED DRUG REGISTRATION 43

4.1. APPLICATION AND APPROVAL PROCEDURE FOR IMPORTED DRUGS 44

4.2.SUPPLEMENTARY APPLICATION AND APPROVAL PROCEDURE FOR

IMPORTED DRUGS 46

4.3.APPLICATION AND APPROVAL PROCEDURE FOR CLINICAL TRIALS 48

PART II. A GUIDANCE OF REGISTRATION APPLICATION FOR IMPORTED

CHEMICAL DRUGS 50

CHAPTER II-1. INTRODUCTION 50

CHAPTER II-2. CLASSIFICATION OF CHEMICAL DRUG

REGISTRATION 52

CHAPTER II-3. MATERIAL ITEMS FOR APPLICATION OF DRUG

REGISTRATION 54

3.1. COMPREHENSIVE MATERIALS 54

3.2. RESEARCH MATERIALS OF PHARMACEUTICS 57

3.3. RESEARCH MATERIALS OF PHARMACOLOGY AND TOXICOLOGY 59

3.4. MATERIALS OF CLINICAL INVESTIGATION 61

CHAPTER II-4. REQUIREMENTS OF MATERIAL ITEMS FOR

APPLICATION OF DRUG REGISTRATION 62

4.1. THE FORM OF MATERIAL ITEMS 63

4.2. THE EXPLANATORY NOTES OF MATERIAL ITEMS 65

CHAPTER II-5. REQUIREMENTS OF CLINICAL TRIAL FOR

APPLICATION OF DRUG REGISTRATION 70

5.1. GENERAL REQUIREMENTS OF CLINICAL TRIAL 70

5.2. SPECIAL REQUIREMENTS OF CLINICAL TRIAL FOR IMPORTED DRUGS 73

CHAPTER II-6. MATERIAL AND CLINICAL TRIAL REQUIREMENTS

FOR RADIOACTIVE PHARMACEUTICALS 74

6.1. DEFINITIONS …74

6.2. REQUIREMENTS OF MATERIAL ITEMS ……..75

6.3. EXPLANATORY NOTES OF MATERIAL ITEMS 75

6.4. REQUIREMENTS OF CLINICAL TRIAL ……...79

PART III. A GUIDANCE OF REGISTRATION APPLICATION FOR

IMPORTED BIOLOGICAL PRODUCTS 79

CHAPTER III-1. INTRODUCTION 79

CHAPTER III-2. CLASSIFICATION OF THERAPEUTIC BIOLOGICAL

PRODUCT REGISTRATION 81

CHAPTER III-3. MATERIAL ITEMS FOR APPLICATION OF

THERAPEUTIC BIOLOGICAL PRODUCT REGISTRATION 84

3.1. COMPREHENSIVE MATERIALS 85

3.2. RESEARCH MATERIALS OF PHARMACEUTICS 87

3.3. RESEARCH MATERIALS OF PHARMACOLOGY AND TOXICOLOGY 90

3.4. MATERIALS OF CLINICAL INVESTIGATION 92

3.5. MISCELLANEOUS 94

CHAPTER III-4. REQUIREMENTS OF MATERIAL ITEMS FOR

APPLICATION OF THERAPEUTIC BIOLOGICAL PRODUCT

REGISTRATION 94

4.1. THE FORM OF MATERIAL ITEMS 95

4.2. THE EXPLANATORY NOTES OF MATERIAL ITEMS 98

CHAPTER III-5. REQUIREMENTS OF CLINICAL TRIAL FOR

APPLICATION OF THERAPEUTIC BIOLOGICAL PRODUCT

REGISTRATION 102

5.1. GENERAL REQUIREMENTS OF CLINICAL TRIAL 102

5.2. SPECIAL REQUIREMENTS OF CLINICAL TRIAL FOR IMPORTED THERAPEUTIC

BIOLOGICAL PRODUCTS 103

CHAPTER III-6. CLASSIFICATION OF PROPHYLACTIC BIOLOGICAL

PRODUCT REGISTRATION 104

CHAPTER III-7. MATERIAL ITEMS FOR APPLICATION OF

PROPHYLACTIC BIOLOGICAL PRODUCT REGISTRATION 106

7.1. COMPREHENSIVE MATERIALS 107

7.2. SUMMARY AND EVALUATION OF RESEARCH RESULTS 109

7.3. RESEARCH MATERIALS OF BACTERIAL (TOXIC) SEEDS FOR

PRODUCTION USE 109

7.4. RESEARCH MATERIALS OF CELL MATRIX FOR PRODUCTION USE 110

7.5. RESEARCH MATERIALS OF PRODUCTION TECHNIQUE 111

7.6. EXPERIMENTAL MATERIALS FOR QUALITY STUDY 111

7.7. REGULATION DRAFT OF PRODUCTION AND ASSAY, DRAFTING

EXPLANATION OF REGULATION, RELEVANT LITERATURE. 112

7.8. RECORDS OF PRODUCTION AND ASSAY FOR SAMPLES TO APPLY FOR

CLINICAL TRIAL 113

7.9. RESEARCH MATERIALS OF INITIAL STABILITY STUDY 113

7.10. THE CERTIFICATES OF INSPECTION FOR TESTING ANIMALS USED

TO PRODUCTION, STUDY AND DETERMINATION. 113

7.11. PLAN AND SCHEME FOR CLINICAL TRIAL. 113

7.12. SUMMARY OF PRE-CLINICAL INVESTIGATION 113

7.13. SUMMARY OF RELEVANT LITERATURE FOR CLINICAL TRIAL. 113

7.14. CLINICAL TRIAL REPORTS, DRAFT OF INFORMED CONSENT FORM,

APPROVAL LETTER OF ETHICS COMMITTEE 114

7.15. WORKING SUMMARY OF IMPROVING PRODUCTION TECHNIQUE AND

QUALITY STANDARD, EXPERIMENTAL MATERIALS OF PHARMACOLOGICAL AND

TOXICOLOGICAL STUDIES DURING CLINICAL TRIALS 114

7.16. RESEARCH MATERIALS FOR DETERMINING PRESERVATION

CONDITION AND EFFECTIVE LIFE OF VACCINES. 114

7.17. MODIFIED CONTENTS AND BASIS FOR REVIEWED REGULATION OF

PRODUCTION AND ASSAY. 114

7.18. RECORDS OF PRODUCTION AND ASSAY FOR 3 SUCCESSIVE

BATCHES OF TRIAL PRODUCTS.114

CHAPTER III-8. REQUIREMENTS OF MATERIAL ITEMS FOR APPLICATION

OF PROPHYLACTIC BIOLOGICAL PRODUCT REGISTRATION 115

8.1. THE FORM OF MATERIAL ITEMS 115

8.2. THE EXPLANATORY NOTES OF MATERIAL ITEMS 117

CHAPTER III-9. REQUIREMENTS OF CLINICAL TRIAL FOR

APPLICATION OF PROPHYLACTIC BIOLOGICAL PRODUCT

REGISTRATION 119

9.1. GENERAL REQUIREMENTS OF CLINICAL TRIAL 119

9.2. SPECIAL REQUIREMENTS OF CLINICAL TRIAL FOR IMPORTED PROPHYLACTIC

BIOLOGICAL PRODUCTS 120

CHAPTER III-10. GUIDELINE FOR APPLICATION OF BIOLOGICAL

PRODUCTS FOR GENE THERAPY 121

10.1. COMPREHENSIVE MATERIALS 122

10.2. RESEARCH CONTENTS FOR PROJECT AND QUALITY CONTROL FOR

PRODUCT 123

10.3. CLINICAL INVESTIGATIONS FOR RESEARCH PROJECT AND PRODUCT 130

CHAPTER III-11. GUIDELINE FOR APPLICATION OF BIOLOGICAL

PRODUCTS FOR SOMATIC CELL THERAPY 134

11.1. COMPREHENSIVE MATERIALS 135

11.2. QUALITY CONTROL FOR PRODUCT 136

11.3. CLINICAL INVESTIGATIONS 141

CHAPTER III-12. GUIDELINE FOR APPLICATION OF BIOLOGICAL

PRODUCTS FOR ALLERGIC THERAPY 143

12.1. QUALITY CONTROL FOR PRODUCTS 143

12.2. REQUIREMENTS FOR PRE-CLINICAL INVESTIGATION 149

12.3. REQUIREMENTS FOR CLINICAL TRIAL 150

PART IV. A GUIDANCE OF REGISTRATION APPLICATION FOR

IMPORTED NATURAL MEDICINES AND TRADITIONAL CHINESE

MEDICINES 151

CHAPTER IV-1. INTRODUCTION 151

CHAPTER IV-2. CLASSIFICATION OF NATURAL MEDICINE AND

TRADITIONAL CHINESE MEDICINE REGISTRATION……154

2.1. DEFINITIONS 154

2.2. CLASSIFICATION OF NATURAL MEDICINE AND TRADITIONAL CHINESE

MEDICINE REGISTRATION 155

CHAPTER IV-3. MATERIAL ITEMS FOR REGISTRATION APPLICATION

OF NATURAL MEDICINES AND TRADITIONAL CHINESE

MEDICINES 159

3.1. COMPREHENSIVE MATERIALS 159

3.2. RESEARCH MATERIALS OF PHARMACEUTICS 161

3.3. RESEARCH MATERIALS OF PHARMACOLOGY AND TOXICOLOGY 163

3.4. MATERIALS OF CLINICAL INVESTIGATION 166

CHAPTER IV-4. REQUIREMENTS OF MATERIAL ITEMS FOR

REGISTRATION APPLICATION OF NATURAL MEDICINES AND

TRADITIONAL CHINESE MEDICINES 167

4.1. DEFINITIONS 168

4.2. THE FORM OF MATERIAL ITEMS 169

4.3. THE EXPLANATORY NOTES OF MATERIAL ITEMS 171

CHAPTER IV-5. REQUIREMENTS OF CLINICAL TRIAL FOR

REGISTRATION APPLICATION OF NATURAL MEDICINES AND

TRADITIONAL CHINESE MEDICINES 176

5.1. GENERAL REQUIREMENTS OF CLINICAL TRIAL 176

5.2. SPECIAL REQUIREMENTS OF CLINICAL TRIAL FOR IMPORTED MEDICINES 177

PART V. CONCLUSION 178

CHAPTER V-1. CONCLUSION 178

PART VI. APPENDICES 181

CHAPTER VI-1 THE DRUG ADMINISTRATION LAW OF THE PEOPLE'S

REPUBLIC OF CHINA 181

CHAPTER VI-2. THE REGULATIONS FOR IMPLEMENTATION OF THE

DRUG ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OF

CHINA 209

CHAPTER VI-3. THE GOOD CLINICAL PRACTICE OF

PHARMACEUTICAL PRODUCTS 235

CHAPTER VI-4. THE GOOD MANUFACTURING PRACTICE FOR

PHARMACEUTICAL PRODUCTS 257

CHAPTER VI-5. THE FORM OF REGISTRATION APPLICATION FOR

IMPORTED DRUG 276

CHAPTER VI-6. REFERENCES 281

CHAPTER VI-7. RESOURCES 282

CHAPTER VI-8. AUTHOR'S BIOGRAPHY 284

CHAPTER VI-9. COMPANY'S DESCRIPTION 285

To order this report:

Alternative Medicine Industry: China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug Registration

Alternative Medicine Business News

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Nicolas BombourgReportlinkerEmail: nbo@reportlinker.comUS: (805)652-2626Intl: +1 805-652-2626

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