Approvals for new drugs imported into Taiwan will be fast-tracked under a streamlined procedure announced April 22 by the ROC Food and Drug Administration.
“The revised process will slash the time it takes for pharmaceuticals to reach the market, enabling patients to receive improved treatment and enhancing the overall standard of health care in Taiwan,” an FDA section chief said.
Effective immediately, drugs will qualify for expedited FDA review and approval if they have been available for at least 10 years in any of the following countries: Australia, Belgium, Canada, France, Germany, Japan, Sweden, Switzerland, the U.K. and U.S.
Under existing rules, a pharmaceutical cannot be greenlighted by the FDA without detailed product safety information and results of an animal toxicology study and three rounds of human clinical trials, the official said.
The new rule takes into account the availability of information and high accreditation standards for drugs in other major nations, the official said, adding that long track records of usage are additional indicators of suitability.
“The FDA will continue mapping out regulations in line with global standards to ensure the safety of Taiwan’s medicines while promoting the local pharmaceutical sector,” the official said. (JSM)
Write to Meg Chang at sfchang@mofa.gov.tw