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Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)

Category : Pharmaceuticals  | Published Date : Jul-2014 | Pages : 191
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China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth as well as an ageing population, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. By 2013, total value of drugs on Chinese healthcare market has reached RMB 1114 billion. On the Chinese healthcare market, imported drugs made by overseas and multinational pharmaceutical manufacturers account for about one fourth. It is estimated that total value of drugs on Chinese healthcare market will be likely to be more than RMB 1450 billion by 2015, and will surpass Japan to become the second largest drug market following the United States. The Chinese healthcare market will attract more and more overseas pharmaceutical manufacturers and producers to penetrate such market. Many overseas and multinational pharmaceutical manufacturers are ardently conducting clinical trials for their drugs in China to seize a larger part of such drug market. However, the Chinese approach to GCP compliance is unique, from the application and approval process, the requirements for ethics committees, sponsors and investigators to the application dossiers. To enter such a lucrative drug market, overseas and multinational pharmaceutical manufacturers and producers must have a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials. Otherwise, the restrictive legal requirements and approval delays eat up your development time and budget.

This Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials for imported drug registration but also introdued the practical operation how to comply with the Chinese GCP to guide you use the Chinese trial venues to keep drug development lean and agile in the “post-patent-cliff” world step by step.

The audiences of this guidebook are overseas pharmaceutical companies wishing to enter into the Chinese drug market, and multinational pharmaceutical companies have penetrated into the Chinese drug market, and their senior executive officers engaging in regulatory affairs expecting to understand how to conduct smoothly clinical trials for their pharmaceutical products in China, and how to comply with the Chinese GCP. After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of Chinese regulations on clinical trials for imported drug registration but also the practical operation how to comply with the Chinese GCP. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational pharmaceutical manufacturers and producers to achieve a successful entry into the Chinese drug clinical trial market, and smoothly operate clinical trial for their products in China.

Chapter 1 Executive Summary 4

Chapter 2 Chinese Applicable Laws and Regulations for Drug Clinical Trials 5

Chapter 3 An Overview of Chinese Authorities for Drug Clinical Trials 7
3.1. CFDA’s Main Responsibilities.7
3.2. CFDA’s Organizational Structure.9
Figure 3.2.1. CFDA’s Organizational Structure.10
Table 3.2.1. CFDA’s affiliated organizations.11
3.3. Roadmap of Application and Approval for Clinical Trials of Imported Drug Registration.13
Figure 3.3.1. Roadmap of Application and Approval for Clinical Trias of Imported Drug Registration.15

Chapter 4 Knowledge Preparation before conducting Imported Drug Clinical Trials 16
4.1. Definitions.16
4.2. Classification of Drugs.18
4.2.1. Classification of Chemical Drugs.19
4.2.2. Classification of Biological Products.20
4.2.2.1. Classification of Therapeutic Biological Products.20
4.2.2.2. Classification of Prophylactic Biological Products.21
4.2.3. Classification of Natural Medicines and Traditional Chinese Medicines (TCMs).22

Chapter 5 General Regulations on Application and Approval for Clinical Trials of Imported Drug Registration 24
5.1. General Regulations on Application and Approval for Clinical Trials of Imported Drug Registration.24
5.2. Special Regulations for Imported Drug Clinical Trials.27

Chapter 6 Every Party’s Responsibilities in Clinical Trials for Imported Drug Registration 32
6.1. The Sponsor’s Responsibilities.32
6.2. The Monitor’s Responsibilities.35
6.3. The Ethics Committee’s Responsibilities.37
6.4. The Investigator’s Responsibilities.38.

Chapter 7 Application and Approval Procedures for Clinical Trials of Imported Drug Registration 40
Figure 7.1. An Entrie Process of Application and Approval Procedures for Imported Drug Registration.41
Figure 7.2. Application and Approval Procedure for Clinical Trials.43

Chapter 8 Application Form for Imported Drug Registration 44
8.1. Drug Registration Application Form for Imported Drug.44
Table 8.1. Drug Registration Application Form for Imported Drug.45
8.2. Explanatory Notes for filling Drug Registration Application Form for Imported Drug. 51

Chapter 9 Practical Guidance for Clinical Trials of Imported Chemical Drug Registration 53
9.1. General Regulations on Clinical Trials for Chemical Drug Registration.53
9.2. Special Regulations for Imported Chemical Drug Clinical Trials.55
9.3. Data and Materils of Application for Approval of Clinical Trials for Imported Chemical Drug Registration.57
9.3.1. Data Items of Application for Approval of Imported Chemical Drug Clinical Trials.57
9.3.2. Requirements for Data and Materials of Application for Approval
of Imported Chemical Drug Clinical Trials.64
9.3.3. Explanatory Notes for Data and Materials of Application for Approval of Imported Chemical Drug Clinical Trials.66
9.3.4. Data and Materials submission of Application for Approval of Imported Chemical Drug Clinical Trials.70

Chapter 10 Practical Guidance for Clinical Trials of Imported Biological Product Registration 72
10.1. Practical Guidance for Clinical Trials of Imported Therapeutic Biological Product Registration.72
10.1.1. General Regulations on Clinical Trials for Imported Therapeutic Biological Product Registration.72
10.1.2. Special Regulations for Imported Therapeutic Biological Product Clinical Trials.73
10.1.3. Data and Materils of Application for Approval of Clinical Trials for Imported Therapeutic Biological Product Registration.74
10.1.4. Requirements for Data and Materials of Application for Approval of Imported Therapeutic Biological Product Clinical Trials.80
10.1.5. Explanatory Notes for Data and Materials of Application for Approval of Imported Therapeutic Biological Product Clinical Trials.84
10.1.6. Data and Materials submission of Application for Approval of Imported Therapeutic Biological Product Clinical Trials.91
10.2. Practical Guidance for Clinical Trials of Imported Preventive Biological Product Clinical Trials.93
10.2.1. General Regulations on Clinical Trials for Preventive Biological Product Registration.94
10.2.2. Special Regulations for Imported Preventive Biological Product Clinical Trials.95
10.2.3. Data and Materils of Application for Approval of Clinical Trials for Imported Preventive Biological Product Registration.95
10.2.4. Requirements for Data and Materials of Application for Approval of Imported Preventive Biological Product Clinical Trials.103
10.2.5. Explanatory Notes for Data and Materials of Application for Approval of Imported Preventive Biological Product Clinical Trials.104
10.2.6. Data and Materials submission of Application for Approval of Imported Preventive Biological Product Clinical Trials.105

Chapter 11 Practical Guidance for Clinical Trials of Imported Natural Medicine and Traditional Chinese Medicine Registration 108
11.1. General Regulations on Clinical Trials for Natural Medicine and Traditional Chinese Medicine Registration. 108
11.2. Special Regulations for Clinical Trials of Imported Natural Medicine and Traditional Chinese Medicine Registration.109
11.3. Data and Materils of Application for Approval of Clinical Trials for Imported Natural Medicine and Traditional Chinese Medicine Registration.109
11.4. Requirements for Data and Materials of Application for Approval of Clinical Trials for Imported Natural Medicines and Traditional Chinese Medicines.115
11.5. Explanatory Notes for Data and Materials of Application for Approval of Clinical Trials of Imported Natural Medicines and Traditional Chinese Medicines.117
11.6. Data and Materials Submission of Application for Approval of Clinical Trials of Imported Natural Medicines and Traditional Chinese Medicines.121

Chapter 12 Appendices 123
12.1. The Drug Administration Law of the People’s Republic of China.123
12.2. The Regulations for Implementation of the Drug Administration Law of the People’s Republic of China.148
12.3. The Good Clinical Practice of Pharmaceutical Products.172

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Publisher Name : Access China Management Consulting Ltd

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