Taiwan Speeds Up Drug License Approvals

The Taiwan Food and Drug Administration (TFDA) said in January 2018 that it approved 20 percent more new drug licenses in 2017 compared to the previous year. The major therapeutic areas of the approved drugs were cancer therapies, rare diseases, diabetes, cardiovascular disease, and infections. Cancer and rare diseases accounted for 20 percent and 11 percent of the approvals respectively, up from 15 percent and 7 percent in 2016.

Overall, the TFDA approved 45 new chemical entity (NCE)/biological drugs and issued 166 new drug licenses (58 of them for NCEs). In 2017, the TFDA launched the “Refusal to File” mechanism to reduce unnecessary reviews and incomplete applications. The median approval time for NCE/biological applications fell to 295 days in 2017, a reduction of 66 days from the previous year.