1. Timing of Ethics Committee (EC) Approval -- According to regulations, EC approval of the protocol must be submitted with other data to SDA in order to obtain clinical trial approval. However, EC wants to evaluate and approve the protocol after the company has obtained clinical trial approval. 2. Lack of Quality Clinical Centers -- The SDA and the Ministry of Health certify hospitals and medical research institutions to conduct clinical trials. At present, there are a total of 125 hospitals (90 hospitals for Western medicine clinical research and 35 for TCM), which serve as clinical study centers. The number of sites is insufficient for new drug research. 3. Limitation on Size of Clinical Trial -- Regulations impose a minimum sample size, typically 20 cases per site. For some low incidence diseases, the site has difficulty meeting the minimum requirement for number of cases. In countries, such as the U.S., there is not such a limitation. 4. Blood Sample Exportation -- Customs requires a certificate from SDA to prove that the blood samples are not for sale. However, SDA considers the clinical trial license sufficient to prove that the blood sample is only part of the clinical trial and not for sale. Because Customs and SDA have not reached an agreement, blood samples are hard to export to central laboratories for testing. This greatly impacts International Trial because blood samples of most of International Trial must be tested in central laboratories, which always are outside China.
