Taiwan Drug Registration Strategy

Taiwan's pharmaceutical market is about $4.5 billion. To be successful in Taiwan, an excellent drug registration strategy is needed.

Taiwan's Department of Health (DOH) is responsible for ensuring the availability and efficiency of medical treatment in Tawian. The Bureau of Pharmaceutical Affairs and the Bureau of Controlled Drugs under the DOH are in charge of establishing laws and policies on the management of pharmaceuticals in Taiwan. These two bureaus have responsibilities such as issuing licenses for importing, exporting, supplying, manufacturing and selling pharmaceuticals and managing the drug testing laboratory certification system in Taiwan.

In addition to the two bureaus mentioned above, the Center for Drug Evaluation (CDE) also assists with the review and evaluation of new drug applications in Taiwan. Established in 1998, the CDE is a non-governmental and non-profit organization. The CDE not only provides a source of professional application reviewers for the DOH, but also helps with clinical trial consultations and the establishment of new pharmaceutical regulatory requirements in Taiwan.

For more information on Taiwan drug approval issues, please see the following PBM publications and/or contact us to discuss your specific needs.