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Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China

  • March 2015
  • -
  • Access China Management Consulting Ltd.
  • -
  • 101 pages

China’s healthcare market is indispensable for overseas and multinational pharmaceutical companies, but Chinese regulations on pharmaceutical clinical trials are undergoing sharp changes. This is first time in history, Chinese pharmaceutical authorities officially issued a guidance on international multi-center clinical trials of drugs in China, which has begun to be implemented on March 1, 2015. To enter into Chinese lucrative drug market, the overseas and multinational pharmaceutical manufacturers must be compliance with this latest regulations. How do respond such challenges? The overseas and multinational pharmaceutical anufacturers and their senior executive officers engaging in regulatory affairs must have a comprehensive and thorough knowledge of the Guidance on Chinese international multi-center clinical trials of drugs, and must be compliance with the latest regulations.

Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China provided a comprehensive and thorough knowledge of the Guidance on international multi-center clinical trials of drugs in China and guide you use the Chinese trial venues to keep drug development lean and to smoothly operate in China step by step.


The organizations of this guidebook are arranged as follows. Chapter 2 provides an overview of the Chinese regulatory authorities -- China Food and Drug Administration (CFDA) being responsible for application and approval for international multi-center clinical trials of drug registration to give the direction of gateway for application for approval of clinical trial of imported overseas drug registration. Chapter 3 elaborates the background of promulgating Guidance. Chapter 4 introduces the applicable scope of Guidance. Chapter 5 introduces the general requirements of international multi-center clinical trials of drugs in China. Chapter 6 elaborates a series of scientific issues that Guidance requires sponsors to be considered. Chapter 7 elaborates a series of compliance issues that Guidance requires sponsors to be considered. Chapter 8 elaborates the clinical trial protocol amendment. Chapter 9 introduces the requirements for using the data from international multi-center clinical trials to support the application for drug registration in China. Chapter 10 introduces the authority, objects, contents, scope and requirements of Chinese drug regulatory authorities implementing inspection and verification on clinical trial sites. Chapter 11 provides a comprehensively and thoroughly practical guidance for application and approval of pharmaceutical international multi-center clinical trials in China, from the knowledge preparation and operation preparation before application, the specific regulations on overseas applicant and application, to the practical operation of application for approval as well as registration and information disclosure of international multi-center clinical trials of drugs in China to smoothly navigate complex regulatory requirements step by step. Chapter 12 provides a comprehensively comparative analysis to reveal the opportunities and challenges of international multi-center clinical trials of drugs in China, and to tell overseas and multinational pharmaceutical companies how to respond challenges. Chapter 13 Appendices provide a complete set of full text in English of application forms involved in application for approval of pharmaceutical international multi-center clinical trials in China, which include “Application Form of Drug Registration”, “Application Form for Special Examination and Approval of New Drug Registration”, and “Application Form for Communication of Special Examination and Approval of New Drug Registration”.

The audiences of this guidebook are overseas pharmaceutical manufacturers 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 apply for international multi-center clinical trials and registration of their pharmaceutical products in China, how to comply with the latest guidance on international multi-center clinical trials of drugs in China.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the latest guidance on international multi-center clinical trials of drugs in China but also the practical operation how to comply with the latest guidance on international multi-center clinical trials of drugs in China. 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 market, and smoothly operate their products in China.

Report Highlights
An overview of organizational structure of Chinese regulatory authorities -- China Food and Drug Administration (CFDA) for approval for international multi-center clinical trials in China to give the direction of gateway for clinical trials of imported drugs.
The background of promulgating Guidance.
The applicable scope of Guidance.
The general requirements of international multi-center clinical trials of drugs in China.
A series of scientific issues that overseas sponsors must be considered.
A series of compliance issues that overseas sponsors must be considered.
The detailed requirements for using the data from international multi-center clinical trials to support the application for imported overseas drug registration in China.
Chinese drug regulatory authorities how to implement the inspection and verification on clinical trial sites.
A comprehensively and thoroughly practical guidance for application and approval of pharmaceutical international multi-center clinical trials in China, from the knowledge preparation and operation preparation before application, the specific regulations on overseas applicant and application, to the practical operation of application for approval as well as registration and information disclosure of international multi-center clinical trials of drugs in China to smoothly navigate complex regulatory requirements step by step.
An entrie process of application and approval procedures for international multi-center clinical trials of drugs in China.
The detailed regulations on registration and information disclosure for international multi-center clinical trials of drugs in China.
A comprehensively comparative analysis to reveal the opportunities and challenges of international multi-center clinical trials of drugs in China, and to tell overseas and multinational pharmaceutical companies how to respond challenges.
A complete set of full text in English of application forms involved in application for approval of pharmaceutical international multi-center clinical trials in China, which include “Application Form of Drug Registration”, “Application Form for Special Examination and Approval of New Drug Registration”, and “Application Form for Communication of Special Examination and Approval of New Drug Registration”.

Table Of Contents

Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China
Table of Contents

Contents.1

Chapter 1 Executive Summary.4

Chapter 2 An Overview of Chinese Regulatory Authorities for Drug Clinical Trials.8
2.1. CFDA's Main Responsibilities.8
2.2. CFDA's Organizational Structure.10
Figure 2.2.1. CFDA's Organizational Structure.11
Table 2.2.1. CFDA's affiliated organizations.12
2.3. Roadmap of Application and Approval for Clinical Trials of Imported Drug Registration.16
Figure 2.3.1. Roadmap of Application and Approval for Clinical Trias of Imported Drug Registration.18

Chapter 3 Background.19

Chapter 4 Applicable Scope.22

Chapter 5 General Requirements.23
5.1?Basic Conditions of International Multi-center Clinical Trials for Drugs.23
5.2. Belection of Strategies for International Multi-center Clinical Trials of Drugs.24
5.3. Requirements for Accepting International Multi-center Clinical Trial Data for Drug Registration in China.25

Chapter 6 Consideration for Scientific Issues .25
6.1. Epidemiology of Disease.26
6.2. Differences in Medical Practice .27
6.3. Differences in Drug Metabolism.27
6.4. Selection of Dose.28
6.5. Selection of Control Drugs.28
6.6. Assessment Indexes of Efficacy.29
6.7. Consideration for Sample Size.29
6.8?Consideration for Statistics.29
6.9. Collection and Assessment of Adverse Events / Reactions.30
6.10. Other Consideration Issues.30

Chapter 7 Consideration for Compliance Issues.31
7.1. Application for Approval of Clinical Trials and Information Publicity.31
7.2. Approval of Ethics Committee.32
7.3. Language of Documents.32
7.4. Informed Consent.32
7.5. Information Submission.33
7.6. Compensation to Trial Subjects.33
7.7. Information about Clinical Trial Drug.33
7.8. Biological Samples.34
7.9. Data Processing Centers.34
7.10. Collection and Assessment of Adverse Events (AE).34
7.11. Application of Computerized System.35
7.12. Monitoring and Verifying for Clinical Trial Centers.35

Chapter 8 Clinical Trial Protocol Amendment.35

Chapter 9 Application for Drug Registration.36

Chapter 10 Inspection and Verification on Sites.37

Chapter 11 Practical Guidance for Application and Approval of Pharmaceutical International Multi-Center Clinical Trials in China .38
11.1. Knowledge Preparation before Application for Approval of International Multi-Center Clinical Trials of Drugs in China.38
11.1.1. Specific Regulations on Overseas Applicant to Apply for International Multi-Center Clinical Trials of Drugs in China.38
11.1.2. Special Examination and Approval Procedures for Innovative Drugs, New Drugs for Treatment of Difficult and Critical Diseases.40
11.1.3. What Pharmaceutical Products may be Applied for International Multi-Center Clinical Trials in China.44
11.2. Practical Guidance for Application and Approval of Pharmaceutical International Multi-Center Clinical Trials in China.45
11.2.1. Preparation before Application for Approval of International Multi-Center Clinical Trials of Drugs in China.45
11.2.2. Specific Provisions on Application for Approval of International Multi-Center Clinical Trials of Drugs in China .47
11.2.3. Practical Operation of Application for Approval of International Multi-Center Clinical Trials of Drugs in China.51
11.2.4. Application and Approval Procedure for International Multi-Center Clinical Trials of Drugs in China.54
Figure 11.2.4. Application and Approval Procedure for International Multi-Center Clinical Trials of Drugs in China.55
11.2.5. Registration and Information Disclosure for International Multi-Center Clinical Trials of Drugs in China.56

Chapter 12 A Comprehensive Analysis
---- Opportunities and Challenges of International Multi-Center Clinical Trials of Drugs in China.70
12.1. What are Opportunities of International Multi-Center Clinical Trials in China?.70
Figure 12.1. Quantity of Clinical Trials in Chinese Region Registered on ClinicalTrial.gov.72
Figure 12.2. Quantity of Global Clinical Trials Registered on ClinicalTrial.gov.72
12.2.What are Challenges of International Multi-Center Clinical Trials in China?.73
Table 12.2. Approval Timeframe and Regulatory System for Clinical Trials.76

Chapter 13 Appendices.80
Appendix 1 Application Form for Special Examination and Approval of New Drug Registration .80
Appendix 2 Application Form for Communication of Special Examination and Approval of New Drug Registration.86
Appendix 3 Application Form of Drug Registration.97

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