Taiwan to mandate Good Clinical Practice standards in new pharmaceutical applications

Seeking to align Taiwan’s pharmaceutical clinical practice methods with international standards, the nation’s top health safety agency is strengthening its protocols for review and approval of new drugs.


Starting July 1, 2021, Taiwan’s Food and Drug Administration (FDA) will require that pharmaceutical trials adhere to internationally recognized Good Clinical Practice (GCP) standards,  the international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials.


The decision by Taiwan’s FDA was published as a guideline on May 28 several months ago. The new requirements are not expected to increase the amount of time generally needed for drug manufacturers to obtain approval of their products.