|
EXECUTIVE
SUMMARY
.1
Table of Contents
.6
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. SFDAS MAIN RESPONSIBILITIES 14
2.2. SFDAS 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 PEOPLES
REPUBLIC OF CHINA 181
CHAPTER VI-2. THE REGULATIONS FOR IMPLEMENTATION OF THE DRUG ADMINISTRATION LAW
OF THE PEOPLES 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. AUTHORS BIOGRAPHY 284
CHAPTER VI-9. COMPANYS DESCRIPTION 285
|