What is the nature of the current clinical trial landscape in China
1. What is the nature of the current clinical trial landscape in China?
In China, the clinical trial is a key point for drug registration. Currently, the clinical trial application and approval becomes more and more transparent and lots of clinical trials are conducted in China.
2. How many trials are being conducted annually in the country?
According to Year 2009 statistic data announced by State Food and Drug Administration, there were 298 clinical trials for new drug, 196 clinical trials for generic drug and 320 clinical trials for imported drug. According to Year 2008 statistic data, there were 581 clinical trials for new drug, but there wasn’t any specific data for generic drug or imported drug.
According to Year 2007 statistic data, there were 758 clinical trials for new drug, but there wasn’t any specific data for generic drug or imported drug.
3. What is the process for submitting clinical trial data in China when seeking approval for generic and new drugs?
The general process for new drugs clinical trial approval are as follow:
1. Submit for new drug clinical trial application;
2. Provincial Food and Drug Administration’s previous examination and accept the application
3. Provincial Food and Drug Administration’s formal examination
4. Drug quality compliance and drug registration inspection
5. The State Food and Drug Administration’s technical review
6. If some documents need to be supplemented, the supplementation shall be completed only once within 4 months
7. The State Food and Drug Administration Drug Evaluation Center’s technical review
8. If qualified through review, State Food and Drug Administration shall issue the approval document for drug clinical trial
9. Delivery the approval to applicant.
4. How many clinical research centers have been established by the Chinese government? Is it possible to obtain a list of these sites and their locations?
According to the list announced by State Food and Drug Administration, there are 1051 pre-clinical research centers in China and please visit the website of State Food and Drug Administration for details: (http://app1.sfda.gov.cn/datasearch/face3/base.jsp?tableId=19&tableName=TABLE19&title=药物临床试验机构名单&bcId=118714941832181502104731901420); there are 394 clinical trial centers in China and please refer to app1.sfda.gov.cn/datasearch/face3/base.jsp=药物临床试验机构名单&bcId=118714941832181502104731901420 for details.
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