Executive Summary
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 organizations of this guidebook are arranged as follows. Chapter 2 provides an overview of the Chinese applicable laws and regulations for drug clinical trials. Chapter 3 introduced an overview of Chinese regulatory authorities for drug clinical trials to give the direction of gateway for clinical trials of imported drugs. Chapter 4 elaborated the definitions of some basic terms used in application and approval process of clinical trials for drug registration and the Chinese unique classification of drug registration, from the chemical drugs, biological products, natural medicines to traditional Chinese medicines (TCMs). Chapter 5 introduced the general regulations on application and approval for clinical trials of imported drug registration. Chapter 6 introduced the every party’s responsibilities in clinical trials for imported drug registration. Chapter 7 delineated an entrie process of application and approval procedures for clinical trials of imported drug registration. Chapter 8 provided the full text in English of “Drug Registration Application Form for Imported Drug” to guide you fill it step by step. Chapter 9 gave the practical guidance for clinical trials of imported chemical drug registration, from the general and special regulations on clinical trials for imported chemical drug registration, the requirements for data and materials of application for approval of clinical trials for imported chemical drugs to the data and materials submission of application for approval of clinical trials for imported chemical drugs.

Chapter 10 provided the practical guidance for clinical trials of imported biological product registration, also from the general and special regulations on clinical trials for imported biological product registration, the requirements for data and materials of application for approval of clinical trials for imported biological products to the data and materials submission of application for approval of clinical trials for imported biological products. Chapter 11 introduced the practical guidance for clinical trials of imported natural medicine and traditional Chinese medicine registration, again from the general and special regulations on clinical trials for imported natural medicine and
traditional Chinese medicine registration, the the requirements for data and materials of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to the data and materials submission of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines. Chapter 12 Appendices provided the full text in English of “Drug Administration Law of the People’s Republic of China”, “Regulations for Implementation of the Drug Administration Law of the People’s Republic of China” and “The Chinese Good Clinical Practice of Pharmaceutical Products”.

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.

Report Highlights
- An overview of the Chinese applicable laws and regulations for drug clinical trials.
- An overview of organizational structure of Chinese regulatory authorities for drug clinical trials to give the direction of gateway for clinical trials of imported drugs.
- The Chinese definitions of some basic terms used in application and approval process of drug clinical trials for drug registration, and the Chinese unique classification of drug registration, from the chemical drugs, biological products, natural medicines to traditional Chinese medicines (TCMs).
- Chinese unique every party’s responsibilities in clinical trials for imported drug registration.
- An entrie process of application and approval procedures for clinical trials of imported drug registration.
- The full text in English of “Drug Registration Application Form for Imported Drug”.
- The practical guidance for clinical trials of imported chemical drug registration, from the general and special regulations on clinical trials for imported chemical drug registration, the requirements for data and materials of application for approval of clinical trials for imported chemical drugs to the data and materials submission of application for approval of clinical trials for imported chemical drugs to smoothly navigate complex regulatory requirements step by step.
- The practical guidance for clinical trials of imported biological product registration, also from the general and special regulations on clinical trials for imported biological product registration, the requirements for data and materials of application for approval of clinical trials for imported biological products to the data and materials submission of application for approval of clinical trials for imported biological products to smoothly navigate complex regulatory requirements step by step..
- The practical guidance for clinical trials of imported natural medicine and traditional Chinese medicine registration, again from the general and special regulations on clinical trials for imported natural medicine and traditional Chinese medicine registration, the requirements for data and materials of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to the data and materials submission of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to smoothly navigate complex regulatory requirements step by step..
- A set of full text in English of Chinese laws and regulations for pharmaceutical product clinical trials.

Who should buy this report?
- Overseas pharmaceutical companies wishing to enter into the Chinese drug market.
- Multinational pharmaceutical companies have penetrated into the Chinese drug market.
- Companies interested in understanding the latest Chinese laws and regulations for pharmaceutical product clinical trials.
- Senior executive officers engaging in regulatory affairs for imported drugs into Chinese lucrative drug market.
- Senior executive officers engaging in conducting clinical trials for imported drugs in China.

Table Of Contents

Table of Contents
Table of Contents....1
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 organizations11
3.3. Roadmap of Application and Approval for Clinical Trials of Imported Drug
Registration13
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
Trials16
4.1. Definitions...16
4.2. Classification of Drugs..18
4.2.1. Classification of Chemical Drugs19
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 Registration24
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 Responsibilities35
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 Trials55
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 Registration72
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 Trials91
10.2. Practical Guidance for Clinical Trials of Imported Preventive Biological Product
Clinical Trials93
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 Products172

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