Taiwan FDA Sets up Fast-Track Approval for Imported Drugs

From April 2013, a new group of imported drugs will be eligible for fast-track approval in Taiwan. These include chemical drugs that have been on the market for more than ten years in the following countries: Japan, Germany, Belgium, France, Austria, Switzerland, Sweden, the UK, Canada and the US.

Previously, such drugs required detailed product safety information, animal toxicology studies and three rounds of local clinical trials before approval. But according to a Taiwan Food and Drug Administration official, the “long track records and high accreditation standards” used to certify these drugs means they can be placed on the Taiwan market without risk.

The fast-track approval process should cut three to six months off the current approval process for new drugs, which is about one year.