Regulations for Registration of Medicinal Products Article 22

The information and local clinical data required for the application of drug registration or post-approval changes should comply with the following regulations:1.Clinical trials conducted in Taiwan should follow the Regulations for GCP (Good Clinical Practice), as well as the Notices for the Application of Clinical Trials and the Guidelines on Bridging Studies as announced by the central health competent authority.2.Before conducting a clinical trial, the manufacturer should submit a protocol, a protocol summary and an application form to the central competent health authority for assessment.3.After the application is approved by the central health competent authority and an official approval letter is issued, the manufacturer should carry out the clinical trial according to the comments provided with the assessment results. After the completion of the clinical trial, the results should be submitted for inspection.Clinical data from foreign countries submitted together with the application should have a comparison with a control group or a double-blind test design. This data cannot be substituted by a general descriptive document, summarized data or individual case report. The regulations set forth in the preceding item are applicable to the technical data of local clinical trials.