China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug Registration

This publication has been discontinued on June 6, 2011.

Below is the updated product.

Introduction

Abstract

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.

Company' s Description

Access China Management Consulting Ltd is a professional provider of managements and consulting services specifically designed to provide overseas clients a virtual gateway to enter the lucrative market of China. Access China is headquartered in Nanjing, Jiangsu Province, Eastern China.

At present, company provides consulting services for foreign clients as follows.

• Research of Chinese pharmaceutical industry and market;
• license transfer; registration of imported drugs and new drugs; pharmaceutical patent applications; management of laws and regulations on pharmaceuticals;
• Consultancy on the Chinese laws, administrative regulations on pharmaceutical administration;
• Provide analyses of feasibility for mergers and acquisitions of the existing Chinese pharmaceutical enterprises;
• Act as agent, within a range of authorized, implement operation to purchase and merge the existing Chinese pharmaceutical enterprises in accordance with the order of foreign investors;
• Help foreign investors make the registration of Foreign Investment Enterprises, including Sino-foreign equity joint ventures (EJV), Sino-foreign cooperative joint ventures (CJV),wholly foreign-owned enterprises (WFOE), Representative Office;
• Provide a range of customized and standardized solutions including industry report, research report of strategic investment, market analyses, and other subscription-based research and information on the latest development and strategies used in a variety of sectors.

Table of Contents

EXECUTIVE SUMMAR

Table of Contents

PART I. A COMPREHENSIVE GUIDANCE OF IMPORTED DRUG REGISTRATION

CHAPTER I-1. INTRODUCTION

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

• 2.1. SFDA' S MAIN RESPONSIBILITIES
• 2.2. SFDA' S ORGANIZATION STRUCTURE

CHAPTER I-3. GENERAL REGULATIONS ON APPLICATION AND APPROVAL FOR IMPORTED DRUG REGISTRATION

• 3.1. CLASSIFICATION OF DRUGS
• 3.2. DEFINITIONS
• 3.3. GENERAL REGULATIONS ON APPLICATION AND APPROVAL FOR IMPORTED DRUG REGISTRATION
  • 3.3.1. APPLICATION AND APPROVAL FOR IMPORTED DRUGS
  • 3.3.2. APPLICATION AND APPROVAL FOR REPACKAGING OF IMPORTED DRUG
  • 3.3.3. SUPPLEMENTARY APPLICATION
  • 3.3.4. RE-REGISTRATION
  • 3.3.5.CLINICAL INVESTIGATION
    • 3.3.5.1.PRECLINICAL INVESTIGATION
    • 3.3.5.2.CLINICAL TRIALS
  • 3.3.6. TIME LIMITS IN DRUG REGISTRATION

CHAPTER I-4. APPLICATION AND APPROVAL PROCEDURES FOR IMPORTED DRUG REGISTRATION

• 4.1. APPLICATION AND APPROVAL PROCEDURE FOR IMPORTED DRUGS
• 4.2.SUPPLEMENTARY APPLICATION AND APPROVAL PROCEDURE FOR IMPORTED DRUGS
• 4.3.APPLICATION AND APPROVAL PROCEDURE FOR CLINICAL TRIALS

PART II. A GUIDANCE OF REGISTRATION APPLICATION FOR IMPORTED CHEMICAL DRUGS

CHAPTER II-1. INTRODUCTION

CHAPTER II-2. CLASSIFICATION OF CHEMICAL DRUG REGISTRATION

CHAPTER II-3. MATERIAL ITEMS FOR APPLICATION OF DRUG 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

CHAPTER II-4. REQUIREMENTS OF MATERIAL ITEMS FOR APPLICATION OF DRUG REGISTRATION

• 4.1. THE FORM OF MATERIAL ITEMS
• 4.2. THE EXPLANATORY NOTES OF MATERIAL ITEMS

CHAPTER II-5. REQUIREMENTS OF CLINICAL TRIAL FOR APPLICATION OF DRUG REGISTRATION

• 5.1. GENERAL REQUIREMENTS OF CLINICAL TRIAL
• 5.2. SPECIAL REQUIREMENTS OF CLINICAL TRIAL FOR IMPORTED DRUGS

CHAPTER II-6. MATERIAL AND CLINICAL TRIAL REQUIREMENTS FOR RADIOACTIVE PHARMACEUTICALS

• 6.1. DEFINITIONS
• 6.2. REQUIREMENTS OF MATERIAL ITEMS
• 6.3. EXPLANATORY NOTES OF MATERIAL ITEMS
• 6.4. REQUIREMENTS OF CLINICAL TRIAL

PART III. A GUIDANCE OF REGISTRATION APPLICATION FOR IMPORTED BIOLOGICAL PRODUCTS

CHAPTER III-1. INTRODUCTION

CHAPTER III-2. CLASSIFICATION OF THERAPEUTIC BIOLOGICAL PRODUCT REGISTRATION

CHAPTER III-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 III-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 III-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

CHAPTER III-6. CLASSIFICATION OF PROPHYLACTIC BIOLOGICAL PRODUCT REGISTRATION

CHAPTER III-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
• 7.10. THE CERTIFICATES OF INSPECTION FOR TESTING ANIMALS USED TO PRODUCTION, STUDY AND DETERMINATION
• 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 III-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 III-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

CHAPTER III-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 III-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

CHAPTER III-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

PART IV. A GUIDANCE OF REGISTRATION APPLICATION FOR IMPORTED NATURAL MEDICINES AND TRADITIONAL CHINESE MEDICINES

CHAPTER IV-1. INTRODUCTION

CHAPTER IV-2. CLASSIFICATION OF NATURAL MEDICINE AND TRADITIONAL CHINESE MEDICINE REGISTRATION

• 2.1. DEFINITIONS
• 2.2. CLASSIFICATION OF NATURAL MEDICINE AND TRADITIONAL CHINESE MEDICINE REGISTRATION

CHAPTER IV-3. MATERIAL ITEMS FOR REGISTRATION APPLICATION OF NATURAL MEDICINES AND TRADITIONAL CHINESE MEDICINES

• 3.1. COMPREHENSIVE MATERIALS
• 3.2. RESEARCH MATERIALS OF PHARMACEUTICS
• 3.3. RESEARCH MATERIALS OF PHARMACOLOGY AND TOXICOLOGY
• 3.4. MATERIALS OF CLINICAL INVESTIGATION

CHAPTER IV-4. REQUIREMENTS OF MATERIAL ITEMS FOR REGISTRATION APPLICATION OF NATURAL MEDICINES AND TRADITIONAL CHINESE MEDICINES

• 4.1. DEFINITIONS
• 4.2. THE FORM OF MATERIAL ITEMS
• 4.3. THE EXPLANATORY NOTES OF MATERIAL ITEMS

CHAPTER IV-5. REQUIREMENTS OF CLINICAL TRIAL FOR REGISTRATION APPLICATION OF NATURAL MEDICINES AND TRADITIONAL CHINESE MEDICINES

• 5.1. GENERAL REQUIREMENTS OF CLINICAL TRIAL
• 5.2. SPECIAL REQUIREMENTS OF CLINICAL TRIAL FOR IMPORTED MEDICINES

PART V. CONCLUSION

CHAPTER V-1. CONCLUSION

PART VI. APPENDICES

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

CHAPTER VI-2. THE REGULATIONS FOR IMPLEMENTATION OF THE DRUG ADMINISTRATION LAW OF THE PEOPLE' S REPUBLIC OF CHINA

CHAPTER VI-3. THE GOOD CLINICAL PRACTICE OF PHARMACEUTICAL PRODUCTS

CHAPTER VI-4. THE GOOD MANUFACTURING PRACTICE FOR PHARMACEUTICAL PRODUCTS

CHAPTER VI-5. THE FORM OF REGISTRATION APPLICATION FOR IMPORTED DRUG

CHAPTER VI-6. REFERENCES

CHAPTER VI-7. RESOURCES

CHAPTER VI-8. AUTHOR' S BIOGRAPHY

CHAPTER VI-9. COMPANY' S DESCRIPTION

Related Reports