In 2021, the TFDA approved a total of 134 new drug applications, covering products of new ingredients, new therapeutic compounds, new administration routes, new doses or new strengths.  Among them 9 drugs were developed by domestic manufacturers and 125 drugs were imported.  They are for treating cancers, immune system, nervous system, cardiovascular issues, rare diseases, etc.   Most of them were approved via the accelerated review pathway, which reduces the length of review from 360 days to under 240 days.  It signifies that the accelerated review pathway is effective in improving the review efficiency and speeding up the launch of new drugs.

For example, in 2021, the TFDA approved a new targeted therapy via the accelerated review pathway as it showed promise in the treatment of a rare severe disease.  This has made Taiwan the world’s second country, after the US, and the Asia’s first, to approve this new drug which meets unmet medical needs of cancer patients. 

In order to satisfy the public’s medication rights, the TFDA announced an array of drug review pathways, including accelerated review, streamlined review, priority review, accelerated approval, breakthrough designation, orphan drug designation, rare severe disease designation, paediatric designation, etc.  These mechanisms aim to accelerate the review process and speed up the launch of new drugs for patients’ benefits.

To further assist drug manufacturers in scheduling their product launches, the TFDA also announced the “Refuse-to-File Checklist” and the “Drug Review Process Time-Point Control Table”.  These instruments are designed to increase the review transparency and predictability.  The TFDA also introduced a pilot scheme to encourage international drug companies to conduct multi-nation and multi-centre clinical trials in Taiwan, hoping to help patients to access new drugs as early as possible. 

【2022-07-06 / Yahoo News】