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Chinese Guidebook for Conducting Pharma Clinical Trials Market 2016 Share, Trend, Segmentation and Forecast to 2021

Friday, November 4, 2016 2:38
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(Before It's News)

This Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials for imported drug registration but also introduced 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.

Request a sample report @ https://www.wiseguyreports.com/sample-request/5303-latest-guidebook-for-conducting-pharma-clinical-trials-in-china-from-regulations-to-practices-2014-edition

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 entire 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.

Complete report details @ https://www.wiseguyreports.com/reports/5303-latest-guidebook-for-conducting-pharma-clinical-trials-in-china-from-regulations-to-practices-2014-edition

Key points in table of content

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 Trials 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 Materials 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 Materials 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 Materials 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 Materials 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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