Pharmaceutical News
TFDA introduced new measures to improve drug review efficiency

With a view to increasing patients’ access to innovative drugs, the Taiwan Food and Drug Administration (TFDA) approved a total of 136 new drug applications in 2016, including 44 NCE new drugs and 29 new biologics.  Most of them are treatments for cancers, hepatitis C, HIV and rare diseases, as well as vaccines (e.g. 5-in-1 vaccines and quadrivalent flu vaccines).  The government in Taiwan is keen on seeking new treatment choices for patients suffering from severe or life-threatening diseases. 


As the biopharmaceutical industry advances, the TFDA has introduced a series of measures for improving the efficiency and transparency of drug review.  Those measures include the amendment of the new drug review process and schedule control, the refuse-to-file (RTF) mechanism and the pre-NDA meeting pilot system, etc.  The TFDA also revised the Drug Advisory Services Guidelines to clearly establish an advisory mechanism for helping the industry to clear any questions about regulatory science.   Furthermore, the TFDA introduced the module-based rolling review system which allows applicants to submit their data by batches.  The system will expedite the review process, as well as patients’ access to new drugs.


In the aspect of drug review, the TFDA is committed to quality, consistency, clarity, efficiency, transparency and two-way communication.  The TFDA hopes a harmonized drug review system will expedite the launches of new drugs.


The quality, safety and efficacy of drugs provided for patients depend largely on the strict control of the competent health authority.  For any concerns and questions about drug products, the public can enquire health professionals, or visit the TFDA’s product license enquiry website for relevant information on drugs, medical devices and cosmetics.  


【2017-05-10/ MOHW Press Release】