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China Pharmaceutical Guidebook: (2013 Edition) Latest Chinese Regulations for Imported Drug Registration

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Published Date: Jun, 2013
Format: PDF
No of Pages: 245

 
 
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  • Abstract
  • Table of Contents

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. 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 over 20 percent per annum in next three years. China is expected to become the second largest drug market in the world by 2015.

Since the reform and open door policy implemented by the 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 2012, sales of imported drugs have shared one fourth 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 of 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 last “Measures for the Administration of Drug Registration” on July 10 2007, and the last “Measures” entered into force since October 1, 2007. However, the practical operations for application and approval of imported drug registration have been constantly changed, because the amendment of “Measures” is sluggish. Under such circumstance, Access China Management Consulting Ltd published the China Pharmaceutical Guidebook (2013 Edition): 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 main four 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 ---- China Food and Drug Administration (CFDA), 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 ---- CFDA 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 CFDA’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 CFDA, 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 later and 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 CFDA 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 CFDA does not provide the harmonized 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 CFDA, 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 CFDA’s requirements for materials and clinical trials of application and approval for imported traditional Chinese medicine. The CFDA 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 CFDA, 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 Implementation of the Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, references, 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 (2013 Edition) ---- 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 CFDA (The China 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 Application Form of Registration for Imported Drug, and so on.

Table of Contents.1
Executive Summary.6
PART I. A COMPREHENSIVE GUIDAENCE OF IMPORTED DRUG REGISTRATION.12

Chapter I-1. Introduction.12

Chapter I-2. The China Food and Drug Administration.14
2.1. CFDA’s Main Responsibilities.15
2.2. CFDA’s Organizational Structure.17
Figure 2.2.1. CFDA’s Organizational Structure.18
Table 2.2.1. CFDA’s affiliated organizations.19
2.3.Roadmap of Application and Approval for Imported Drug Registration21
Figure 2.3.1. Roadmap of Application and Approval for Imported Drug Registration.23

Chapter I-3. General Regulations on Application and Approval for Imported Drug Registration.24
3.1. Classification of Drugs.24
3.2. Definitions.24
3.3. General Regulations on Application and Approval for Imported Drug Registration.28
3.3.1. Application and Approval for Imported Drugs.28
3.3.2. Application and Approval for Repackaging of Imported Drug.32
3.3.3. Supplementary Application.34
3.3.4. Re-registration.35
3.3.5. Clinical Trials.37
3.3.6. Time Limits in Drug Registration.41

Chapter I-4. Application and Approval Procedures for Imported Drug Registration.44
4.1. Application and Approval Procedure for Imported Drugs.44
Figure 4.1.1. Application and Approval Procedure for Imported Drugs (1).45
Figure 4.1.2. Application and Approval Procedure for Imported Drugs (2).46
4.2.Supplementary Application and Approval Procedure for Imported Drugs.47
Figure 4.2.1. Supplementary Application and Approval Procedure for Imported Drugs(1).47
Figure 4.2.2. Supplementary Application and Approval Procedure for Imported Drugs (2).48
4.3.Application and Approval Procedure for Clinical Trials.48
Figure 4.3.1. Application and Approval Procedure for Clinical Trials.49

Chapter I-5. Application Form for Imported Drug Registration.50

PART II. A GUIDANCE OF REGISTRATION APPLICATION FOR IMPORTED CHEMICAL DRUGS.55

Chapter II-1. Introduction.55

Chapter II-2. Classification of Chemical Drug Registration.56

Chapter II-3. Material Items for Application of Drug Registration.58
3.1. Summary Materials.59
3.2. Research Materials of Pharmaceutics.61
3.3. Research Materials of Pharmacology and Toxicology.63
3.4. Materials of Clinical Investigation.65

Chapter II-4. Requirements of Material Items for Application of Drug Registration.66
4.1. The Form of Material Items.66
4.2. The Explanatory Notes of Material Items.68

Chapter II-5. Requirements of Clinical Trial for Application of Drug Registration.73
5.1. General Requirements of Clinical Trial.73
5.2. Special Requirements of Clinical Trial for Imported Drugs.75

Chapter II-6. Material and Clinical Trial Requirements for Radioactive Pharmaceuticals.77
6.1.Definitions.77
6.2.Requirements of Material Items.77
6.3.Explanatory Notes of Material Items.78
6.4.Requirements of Clinical Trial.81

PART III. A GUIDANCE OF REGISTRATION APPLICATION FOR IMPORTED BIOLOGICAL PRODUCTS.82

Chapter III-1. Introduction.82

Chapter III-2. Classification of Therapeutic Biological Product Registration.84

Chapter III-3. Material Items for Application of Therapeutic Biological Product Registration.86
3.1. Summary Materials.86
3.2. Research Materials of Pharmaceutics.88
3.3. Research Materials of Pharmacology and Toxicology.90
3.4. Materials of Clinical Investigation.92
3.5. Miscellaneous. 93

Chapter III-4. Requirements of Material Items for Application of Therapeutic Biological Product Registration.94
4.1. The Form of Material Items.94
4.2. The Explanatory Notes of Material Items.98

Chapter III-5. Requirements of Clinical Trial for Application of Therapeutic Biological Product Registration.104
5.1. General Requirements of Clinical Trial.104
5.2. Special Requirements of Clinical Trial for Imported Therapeutic Biological Products.105

Chapter III-6. Classification of Prophylactic Biological Product Registration.106

Chapter III-7. Material Items for Application of Prophylactic Biological Product Registration.108
7.1. Summary Materials.108
7.2. Summary and Evaluation of Research Results.110
7.3. Research Materials of Bacterial (Toxic) Strains for Production Use.110
7.4. Research Materials of Cell Matrix for Production Use.111
7.5. Research Materials of Production Technique.112
7.6. Experimental Materials for Quality Study, and Research Materials of Pre-clinical Efficacy and Safety.113
7.7. Regulation Draft of Production and Assay, Drafting Explanation of Regulation, Relevant Literature.114
7.8. Records of Production and Assay for Samples to apply for Clinical Trial.114
7.9. Research Materials of Initial Stability Study.114
7.10. The Quality Certificate of Animal used for Production, Research and Test .114
7.11. Plan and Scheme for Clinical Trial.114
7.12. Summary of Pre-clinical Investigation.115
7.13. Summary of Relevant Literature for Clinical Trial.115
7.14. Clinical Trial Reports, Draft of Informed Consent Form, Approval Letter of Ethics Committee.115
7.15. Working Summary of Improving Production Technique and Quality Standard, Experimental Materials of Pharmacological and Toxicological Studies during Clinical Trials.115
7.16. Research Materials for Determining Preservation Condition and Effective Life of Vaccines.115
7.17. Modified Contents and Basis for Reviewed Regulation of Production and Assay.115
7.18. Records of Production and Assay for 3 Successive Batches of Trial Products.115

Chapter III-8. Requirements of Material Items for Application of Prophylactic Biological Product Registration.116
8.1. The Form of Material Items.116
8.2. The Explanatory Notes of Material Items.118

Chapter III-9. Requirements of Clinical Trial for Application of Prophylactic Biological Product Registration.120
9.1. General Requirements of Clinical Trial.120
9.2. Special Requirements of Clinical Trial for Imported Prophylactic Biological Products.121

Chapter III-10. Guideline for Application of Biological Products for Gene Therapy.122
10.1. Summary Materials.122
10.2. Research Contents for Project and Quality Control for Product.124
10.3. Clinical Investigations for Research Project and Product.129

Chapter III-11. Guideline for Application of Biological Products for Somatic Cell Therapy.133
11.1. Summary Materials.134
11.2. Quality Control for Product.134
11.3. Clinical Investigations.138

Chapter III-12. Guideline for Application of Biological Products for Allergic Therapy.141
12.1. Quality Control for Products.141
12.2. Requirements for Pre-clinical Investigation.146
12.3. Requirements for Clinical Trial.147

PART IV. A GUIDANCE OF REGISTRATION APPLICATION FOR IMPORTED NATURAL MEDICINES AND TRADITIONAL CHINESE MEDICINES.148

Chapter IV-1. Introduction.148

Chapter IV-2. Classification of Natural Medicine and Traditional Chinese Medicine Registration.150
2.1. Definitions.150
2.2. Classification of Medicine Registration.151

Chapter IV-3. Material Items for Registration Application of Natural Medicines and Traditional Chinese Medicines.154
3.1. Summary Materials.154
3.2. Research Materials of Pharmaceutics.156
3.3. Research Materials of Pharmacology and Toxicology.157
3.4. Materials of Clinical Investigation.160

Chapter IV-4. Requirements of Material Items for Registration Application of Natural Medicines and Traditional Chinese Medicines.161
4.1. Definitions.161
4.2. The Form of Material Items.161
4.3. The Explanatory Notes of Material Items.164

Chapter IV-5. Requirements of Clinical Trial for Registration Application of Natural Medicines and Traditional Chinese Medicines.169
5.1. General Requirements of Clinical Trial.169
5.2. Special Requirements of Clinical Trial for Imported Medicines.170

PART V. CONCLUSION.171

Chapter V-1. Conclusion.171

PART VI. APPENDICES.174

Chapter VI-1 The Drug Administration Law of the People’s Republic of China.174

Chapter VI-2. The Regulations for Implementation of the Drug Administration Law of the People’s Republic of China.199

Chapter VI-3. The Good Clinical Practice of Pharmaceutical Products.223

Chapter VI-4. References.243

Chapter VI-5. Company’s Description.244

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