Pharmaceutical News
TFDA approved a record breaking 170 new drugs last year

Reported by Chen Jun-Kai from Taipei


In order to increase the nation’s access to new drugs, the TFDA has sped up the review procedure for new drugs.  According to the TFDA, 170 new drugs were approved last year, up by 30%.  This was a record breaking achievement.  Among the approved new drugs, 13% are cancer drugs.  They also included 2 new drugs which were developed and had their world debut in Taiwan, bringing benefits to Taiwanese patients with hyperphosphatemia and metastatic pancreatic cancer.


According to the TFDA’s data, 27 cases out of the total 170 approved cases are new drugs developed in Taiwan, and 143 cases are imported drugs.  The number of successful applications filed by local developers has been on a rise five years in a row.


Lin Yi-Chu, a Section Chief of the TFDA, expressed that among all the new drugs approved last year, 49 cases are NCE new drugs and 44 cases are biopharmaceuticals.  After breaking down by therapeutic categories, cancer drugs have the highest proportion, accounting for 13%.  Other therapeutic categories include treatments for hepatitis C, HIV, rare diseases, vaccines, etc.


The two cases which had their world debut in Taiwan are for treating hyperphosphatemia and metastatic pancreatic cancer respectively.


The TFDA also announced the “Mechanism for NDA Priority Review” and the “Mechanism for NDA Fast Track Review”, which aim to expedite the review process for new compound and new administration route.   Last year, 15 cases were qualified for priority review.  For whom, the review time was significantly reduced from 300-400 days to just 171 days.


【2016-01-27/ Now News】