Home > > > > Report Detail

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

Publisher Name :
Date: 19-Mar-2015
No. of pages: 101

"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”.


Scope

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.

Reasons To Buy

"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.To understand the latest guidance on international multi-center clinical trials of drugs in China, you must read the Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China. 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.

Key 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”.

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

Table of Contents

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

List of Tables

Table 2.2.1. CFDA’s affiliated organizations.
Table 12.2. Approval Timeframe and Regulatory System for Clinical Trials.
Application Form for Special Examination and Approval of New Drug Registration
Application Form for Communication of Special Examination and Approval of New Drug Registration
Application Form of Drug Registration

List of Figures
Figure 2.2.1. CFDA’s Organizational Structure.
Figure 2.3.1. Roadmap of Application and Approval for Clinical Trias of Imported Drug Registration.
Figure 11.2.4. Application and Approval Procedure for International Multi-Center Clinical Trials of Drugs in China.
Figure 12.1. Quantity of Clinical Trials in Chinese Region Registered on ClinicalTrial.gov.
Figure 12.2. Quantity of Global Clinical Trials Registered on ClinicalTrial.gov.

  • Global Clinical Trial Support Services Industry Research Report, In-depth Analysis of Current Status and Outlook of Key Countries 2023-2028
    Published: 28-Dec-2023        Price: US 3380 Onwards        Pages: 107
    Market Overview of Global Clinical Trial Support Services market: According to our latest research, the global Clinical Trial Support Services market looks promising in the next 5 years. As of 2022, the global Clinical Trial Support Services market was estimated at USD XX million, and it's anticipated to reach USD XX million in 2028, with a CAGR of XX% during the forecast years. Clinical trial support services are the various services, which pharmaceutical companies use durin......
  • Global Clinical Trial Supplies Industry Research Report, In-depth Analysis of Current Status and Outlook of Key Countries 2023-2028
    Published: 21-Dec-2023        Price: US 3380 Onwards        Pages: 108
    Market Overview of Global Clinical Trial Supplies market: According to our latest research, the global Clinical Trial Supplies market looks promising in the next 5 years. As of 2022, the global Clinical Trial Supplies market was estimated at USD 1939.69 million, and it's anticipated to reach USD 3477.51 million in 2028, with a CAGR of 10.22% during the forecast years. This report covers a research time span from 2018 to 2028, and presents a deep and comprehensive analysis of ......
  • Global Clinical Trial Management System (CTMS) Industry Research Report, In-depth Analysis of Current Status and Outlook of Key Countries 2023-2028
    Published: 09-Nov-2023        Price: US 3380 Onwards        Pages: 106
    Market Overview of Global Clinical Trial Management System (CTMS) market: According to our latest research, the global Clinical Trial Management System (CTMS) market looks promising in the next 5 years. As of 2022, the global Clinical Trial Management System (CTMS) market was estimated at USD XX million, and it's anticipated to reach USD XX million in 2028, with a CAGR of XX% during the forecast years. This report covers a research time span from 2018 to 2028, and presents a ......
  • Global Bladder Cancer Clinical Trials Market Status and Outlook 2023-2028
    Published: 07-Nov-2023        Price: US 3160 Onwards        Pages: 107
    A clinical trial is a research study that tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials are an essential part of cancer research. They may provide possible treatment alternatives to patients who have not had success with standard and approved therapies. Our market research experts provide qualitative and quantitative analysis of the market based on involving economic and non-economic factors in the same report with market value (million US......
  • Clinical Trial Supplies Market by Services (Manufacturing, Packaging, Logistics), Phases, Type (Small Molecules, Biologics), Therapeutic Areas (Oncology, CVD, Infectious, Immunology), End User (Pharma, Biotech, CROs), & Region - Global Forecast to 2028
    Published: 09-Oct-2023        Price: US 4950 Onwards        Pages: 340
    “The clinical trial supplies market is projected to grow at a CAGR of 9.9% during the forecast period of 2023-2028.” The global clinical trial supplies market size is projected to reach USD 6.3 billion by 2028 from USD 3.9 billion in 2023, at a CAGR of 9.9% during the forecast period. Factors such as Increasing number of clinical trials, Growing product pipeline, and Increasing decentralization of clinical trials are likely to have positive impact on the m......
  • Global Clinical Trials Industry Research Report, In-depth Analysis of Current Status and Outlook of Key Countries 2023-2028
    Published: 05-Oct-2023        Price: US 3380 Onwards        Pages: 109
    Market Overview of Global Clinical Trials market: According to our latest research, the global Clinical Trials market looks promising in the next 5 years. As of 2022, the global Clinical Trials market was estimated at USD 29710.78 million, and it's anticipated to reach USD 50447.34 million in 2028, with a CAGR of 9.22% during the forecast years. This report covers a research time span from 2018 to 2028, and presents a deep and comprehensive analysis of the global Clinical Tri......
  • Global Hypoparathyroidism Clinical Trials Market Insights, Forecast to 2029
    Published: 20-Sep-2023        Price: US 4900 Onwards        Pages: 74
    Market Analysis and Insights: Global Hypoparathyroidism Clinical Trials Market The global Hypoparathyroidism Clinical Trials market is projected to grow from US$ million in 2023 to US$ million by 2029, at a Compound Annual Growth Rate (CAGR) of % during the forecast period. The US & Canada market for Hypoparathyroidism Clinical Trials is estimated to increase from $ million in 2023 to reach $ million by 2029, at a CAGR of % during the forecast period of 2023 through 2029. Th......
  • Clinical Trials Market by Phase (Phase I, II, III), Service Type (Laboratory, Analytical Testing, Patient Recruitment, Protocol Designing), Therapeutic Area (Oncology, Cardiology, Neurology), and Application (Vaccine, mAbs, CGT) - Global Forecast to 2028
    Published: 08-Sep-2023        Price: US 4950 Onwards        Pages: 353
    “Increasing number of drugs in pipeline and rise in number of clinical trials are driving the growth of the clinical trials market.” The global clinical trials market is projected to reach USD 73.2 billion by 2028 from USD 48.2 billion in 2023, at a CAGR of 8.7% during the forecast period of 2023 to 2028. The growth of this market can be attributed to the increasing demand for specialized testing services. Companies are increasingly outsourcing specialize......
  • Global Clinical Trials Market Insights, Forecast to 2029
    Published: 08-Aug-2023        Price: US 4900 Onwards        Pages: 111
    Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted ......
    • SERVICES
    Value for Money
    We believe in "optimum utilization of available budget and resources". While servicing our clients' (your) market research requirements, we keep the same approach in focus to help you get the best value for your $$s.
    Ever Growing Inventory
    Ranging from the smallest feasible / required data (datasheets, data facts, SWOT analysis, company profiles, etc) to full research reports that help you make decisions, our inventory is updated almost on a daily basis with the latest industry reports from domain experts that track more than 5000 niche sectors.
    One Stop Solution
    Need a custom research report on medical devices market? Require all available business intelligence on 3D printing industry? Exploring F&B sector of a particular country/region? RnRMarketResearch.com is your one-stop-solution to all market intelligence needs. We not only offer custom research and consulting services, we also "bundle" reports to meet your needs and help you fetch the data analysis you require for your business.
    Dedicated Client Engagement
    Not limited to only "finding" relevant reports for you, our client engagement team dedicates its efforts to understand your "business need" and accordingly maps available research data to help you move forward. Call "your" client engagement executive any time of your day and get your questions answered in order to make the correct business decision.
    Saving Time and Efforts
    Simply share your research requirement details with us and let us do all the hard work to find required intelligence for you. When you add up our "one stop solution" and "dedicated client engagement" services mentioned above, you obviously know the time and effort saving you do by working with us.
    Payment Flexibility
    Working with Fortune 500 organizations, we understand the importance of being flexible for payments. Share your payment terms with us and we will surely match up to them to ensure you get access to required business intelligence data without having to wait for the payment to be done.
    Post-Purchase Research Support
    Have questions after reading a report / datasheet bought through us? Not sure about the methodology used for data available in the research? Talk to us / Share your questions with us and if required, we will connect you with the analyst(s)/author(s) of the report(s) and ensure you get satisfactory answers for the same. Need more data / analysis / report(s) on the topic of your research/project? The RnRMarketResearch.com team is here for you 24X7 to support you with your post-purchase requirements. Subscription Offers & Packages (Get in touch with us for more details - [email protected] / +1 888 391 5441 )
    • Ad Hoc
    • Pay - as - you - go / Bucket Subscriptions
    • Fixed Cost for #of reports
    • Customize / Personalize as per your needs