Taiwan intends to implement Inspection scheme for Bioequivalence Trial ( in 2021)

Towards an aim to ensure the quality and data management of bioequivalence study, the Taiwan Food and Drug Administration ( FDA ) intends to conduct the inspection from the year, 2021.

In order to improve the quality of domestic bioequivalence tests and the credibility of the test data, the Department has informed the schedule of the monitoring verification for bioequivalence tests vide the  letter of FDA No. 1071407461 dated August 20, 2021.

Each agency has to implement accordingly the monitoring verification of the bioequivalence test analysis site and the clinical trial site to improvise on what is lacking and update the standard operating procedures according to the 2019 year verification results, and then follow up the actual improvement test results in the actual implementation year.

The written report is sent to the Department for reference. In order to continue to strengthen the quality, data management, and monitoring of domestic bioequivalence tests, the Department will conduct a monitoring field inspection of bioequivalence tests again in 2021.

If the applied cases need to be clarified and the bioequivalence tests reporting cast doubts, a cause check needs to be initiated in confirming the implementation of clinical trials.

Please refer to http://regulation.cde.org.tw/doc_data_display?sid=2893&doctype2= for more information