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New Drug Approvals in 2017 by Taiwan FDA 【Date:2018-01-25】 unit:藥品組

Taiwan Food and Drug Administration (TFDA) approved 45 NCE/ biological products and issued 166 new drug licenses (58 new chemical entity (NCE), 33 biological products and 75 non- NCE, as attachment) in 2017, based on scientific evidence to ensure safety and quality. It is one of TFDA’s priorities to accelerate the time schedule of drug approval to ensure the publics to receive innovation drugs timely. The number of issued new drug licenses was 20% increase compared to year 2016.

The major therapeutic areas of these approved drugs were cancer therapies, rare diseases, diabetes, cardiovascular diseases and infection diseases. Top two therapeutic areas were cancer therapies (20%) and rare diseases (11%), it is noteworthy that both of them were increased 15% and 7% separately, compared to previous year.

In 2017, TFDA launched the Refusal to File (RTF) mechanism to facilitate review process by reducing unnecessary reviews and incomplete applications. The statistical data showed that the median approval time of NCE/ biological products was 295 days. It was an obvious reduction that review time was 66 days shorter than the previous year. It is no doubt that TFDA made efforts to improve public health and meet the medical needs for all Taiwan people.