Taiwan to conduct GCP inspection in compliance with new drug applications

Taiwan Food and Drug Administration (FDA) published a guideline on 28 May 2020 to improve the efficiency of new drug reviews and strengthen the link between Good Clinical Practice (hereinafter referred to as GCP) inspection and new drug inspection registration review. This will be implemented from 1st July 2021.

This move will promote Taiwan’s  GCP inspection system to be in line with international standards.
GCP inspection operations will be carried out in conjunction with the new drug inspection and registration review process, and the inspection will not affect the number of days for the application of new drug inspection and registration cases.

The GCP inspection results will be reviewed as part of the evaluation of the new drug registration application.

More details regarding the inspection initiation process, the scope of GCP inspection and required documents are in the link: https://www.fda.gov.tw/TC/siteListContent.aspx?sid=4254&id=33249