How to Conduct Clinical Trials in China

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Publication Date: 2008-01-01

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China has established its Chinese Traditional Medicine system for thousands of years, and there was no clinical trial at all before the western drug was introduced in China in recent 100 years. China GCP was introduced in 1998 by MOH and its revised version was introduced in 1999 by SDA (called SFDA from 2003).

China has attempted to streamline its regulation and align the country with international standards of practice; as a result, the country’s legal system governing pharmaceutical research, production, and marketing was modified substantially recent years. One of the examples is that the MOH issued the first version of GCP in 1998. After the establishment of the SDA (now SFDA, State Food and Drug Administration), SFDA formally issued its GCP September 1, 1999, after ten years of work, and the latest version of GCP was issued in 2003 after the new Drug Administration Law went into effect in 2001, and the new Drug Registration Procedure went into effect in 2002. Clinical trial activity in China is on the rise. And also in accordance with requirements of the World Trade Organization (WTO).

China is expected to be the fourth largest pharmaceutical market by 2010, and the average growth rate of China market kept more than 15% since 1978, so is it possible to the conduct trials in China? what are the main challenges to conduct trial in China? What are the strategies to conduct trial in China? In addition, if the sponsor would like to select a CRO in China, how to select?

2002 was a milestone year in China for the promulgation of laws to improve intellectual property protection of pharmaceuticals. For example, as part of China's WTO accession, Chinese authorities promulgated legislation extending all patent coverage to 20 years. Other improvements include provisions for data protection and patent linkage. This is good news for foreign companies that want to introduce new drugs to China.

There are lots of advantages for conducting multinational clinical trials in China: fast patient recruitment, low cost, large patient pool, abound, unique disease resources, experienced and motivated investigator, huge market, shortening the time to market a new drug, GCP compliance database and China government policy adjustment favorable to foreign companies.

China has attempted to streamline its regulations and align the country with international standards of practice. A set of new drug regulations were introduced in 2002, and in mid-2003 more changes were brought in by China SFDA. While some changes are intended to shorten approval timelines, many introduce obstacles into the approvals process. Changes have been aimed at shrinking evaluation timelines to 120 working days, and from Oct 2007, it will be 90 working days. At the same time, China has adjusted the policy of multi-center clinical trial since December 2002.

Since February 19, 2004, SFDA issued a regulation, stating only GCP-certified sites are authorized to conduct clinical trials. At present, 80% of medical resources are allocated in big cities, and 30% of these resources are focused in large hospitals. As a result patient treatment of major maladies is centralized to major hospitals. There are 1.3 billion people in China in 2005. With the first population in the world, China is a country with abound, unique clinical resource, and the adequate patients can make manufacturers to recruit subject in a short time.

The cost of conducting clinical trials in China is relatively low, especially for the lab cost, PI grant and CRA traveling.

So with the establishment of China SFDA, strengthening IPR protection, and regulation environments improvements, more and more multinational clinical trials are introduced in China since 21st century,

Although there are so many benefits to conduct clinical trail in China, there are still lots of challenges for conducting multinational clinical trial in China, such as lengthy approval process for clinical trial, restrictive export of whole blood/DNA, unclear investigator's accountability, quality issue, insufficient training, Lack of qualified/experienced CRAs and project managers, limited logistic support, and local practice, culture, language barrier.

Considering China pharmaceutical regulation compliance with the international standards, great potential market in China, more and more international clinical trial are introduced in China, however, because of the short history of multinational clinical trial in China and there are still some local practices different with the international, so the multinational companies has to learn the local know-how, otherwise, sponsors who lack of such capabilities can access China with the assistance of contract research organizations (CROs).

Previously, it will take 7-9 months to get the regulatory approval from SFDA, which is one of the major complain of the global sponsor to China is the lengthy regulatory review approval process, however, it will be changed from Oct, 2007. Since the regulatory review approval process will be shortened to 90 working days, so it will bring further opportunities to the global pharmaceutical companies.

Table of Contents

Session 1 Global Pharmaceutical industry & China
1.1 Pharmaceutical industry is still profitable
1.2 Pharmaceutical industry growing
1.2.1 The global market is growing
1.2.2 Growth rate is slowing down
1.3 R&D
1.3.1 R&D Spending/sales revenue
1.3.2 R&D Productivity Declining
1.3.3 R&D Spending and Productivity for Various U.S. Industries
1.3.4 More expensive to develop a new medicine
1.4 Strategies
1.4.1 Outsourcing increasing greatly in the world
1.4.2 M&A
1.4.3 Generic Drug
1.4.4 To introduce trial into new countries, such as China
1.5 More Multinational Clinical Trials
Section 2 Pharmaceutical regulatory environments in China
2.1 Basic introduction of China Pharmaceutical industry & multinational companies in China
2.2 Laws & regulation
2.2.1 Intellectual Property Rights
2.2.1.1 Data Exclusivity:ÿD
DD>2.2.1.2 Patent Linkage
2.2.2 Anti-Counterfeiting
2.2.3 Pricing
2.2.4 Hospital Bidding
2.2.5 Reimbursement
2.3 SFDA
2.4 Drug Administration Law of the People's Republic of China (2001 Version)
2.5 GCP development in China
2.6 R&D localization in China
Section 3 GCP status in China
3.1 GCP Evolution
3.2 China GCP vs ICH-GCP
3.3 Questions of GCP implementation
3.3.1 Insufficient Understanding of GCP
3.3.2 Informed Consent Forms
3.4 Differences in Implementing GCP
3.5 Measures being taken or to be taken
3.6 Summary
Section 4 Opportunities to conduct clinical trials in China
4.1 More Multinational trials in China.
4.2 Reasons to conduct multinational clinical trials in China:
4.2.1 Future marketing in China
4.2.2 Fast patient recruitment
4.2.3 Broad Disease Profile.
4.2.4 GCP compliance site.
4.2.5 Increasing scientific innovation from China
4.2.6 Low cost.
4.2.7 Government Policy Adjustment
4.2.8 FDA acceptance
4.2.9 Shortening the time to market a new drug
4.3 China: the most appropriate place to conduct trials apart from US.
4.5 Conclusion
Section 5 Challenges to conduct clinical trials in China
5.1 The global pharmaceutical companies are still eying China
5.2 Challenges to conduct clinical trials in China
5.2.1 Lengthy approval process
5.2.2 Local language barrier
5.2.3 Reporting of adverse events
5.2.4 Hardware and qualified logistic support is limited
5.2.5 Inexperienced Investigator and CRA
5.2.6 The other Local practice
Section 6 How to manage the multinational clinical trial in China
6.1 Project team Identification
6.2 Timelines
6.3 Training
6.4 Start-up plan
6.4.1 Site selection
6.4.2 Central Lab
6.4.3 Drug Supply
6.4.4 Site Contract
6.4.5 EDC
6.5 Monitoring plan
6.6 Risk assessment
6.7 Patient Recruitment
6.8 Regulatory Strategy Planning
Section 7 Regulatory requirements of a trial
7.1 Clinical trial requirements
7.2 Clinical trial
7.2.1 Phases of clinical trial
Phase IV Clinical Trial:
7.2.2 Responsibilities of the applicant
7.2.3 Responsibilities of principal investigator and participating institutions
7.2.4 Suspension or cessation of the clinical trial
7.2.5 International multi-centre drug clinical trial
7.3 Approval of new drug clinical trial
7.3.1 Withdrawal of application
7.3.2 Return of application
7.4 Clinical trial of imported drugs
7.4.1 Basic rules for clinical trial rule for imported drugs
7.4.2 Clinical trial approval procedure for imported drugs
7.4.3 Clinical trial rules for imported drug
7.4.4 Clinical research case number of import chemical drugs
7.5 Investigational Product
7.5.1 The inspection of pilot drug
7.5.2 Management of the pilot drug
7.6 Situations that will result in the non-approval of an imported drugs
Section 8 Feasibility & to select investigator in China
8.1 Things to consider to conduct feasibility study in China
8.1.1 Deploy a Strategy Combining All Intentions
8.1.2 PI’s Comprehension of Feasibility Study
8.1.3 Differences in Medical Terminology
8.1.4 Interpretation of Feasibility Data
8.1.5 Influential Factors other than Medical Practice (cultures, ethnics, economic lures, and etc.)
8.2 Why to conduct feasibility?
8.3 Type of feasibility study
8.4 Benefits of feasibility study
Section 9 Ethics Committee Submission
9.1 Ethics Committees (EC)
9.2 Requirement on the Composition of Independent Ethics Committee
9.3 Function of Ethics Committee
9.4 Submission list example
9.5 timeline
9.6 Future trends of China EC
Section 10 Drug Preparation
10.1 Drug importation
10.2 Drug testing
10.2.1 The evaluation procedure for imported drugs quality standard
10.2.2 Rules for quality standard evaluation
10.2.3 The coverage of quality standard evaluation
10.3 Drug labeling
10.4 Drug Supply
Section 11 Initiation a study
11.1 Contract issue
11.2 PI grant issue
11.3 ICF issue
Section 12 Safety issue
12.1 Safety Related Regulation for clinical trial
12.1.1 China Drug Administration Law
12.1.2 China Drug Administration Law Guideline
12.1.3 China Drug Registration Procedure
12.1.4 China GCP
12.2 Post-marketing Safety Monitoring
12.3 SAE reporting figure
Section 13 To select a CRO in China
13.1 International CROs in China
13.2 CRO market share in China
13.3 How to find an appropriate CRO in China
13.4 Future trends of China CRO industry
Appendix 1 China Good Clinical Practice (2003 version)
Appendix 2 GCP site list in China
Appendix 3 DRUG REGISTRATION REGULATION
Chapter 1: General Principles
Chapter 2: Basic Requirements
Chapter 3: Clinical Trials of Drugs
Chapter 4: Application and Approval of New Drugs
Chapter 5: Application and Approval of Generic Drugs
Chapter 6: Application and Approval for Imported drugs
Chapter 7: Application of OTC Drugs
Chapter 8: Supplemental Application and Approval
Chapter 9: Re-registration of Drugs
Chapter 10: Inspection During Drug Registration
Chapter 11: Drug Registration Standards and Insert Sheets
Chapter 12: Prescribed Timeline
Chapter 13: Reconsideration
Chapter 14: Legal Liability
Chapter 15: Miscellaneous

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