Pharmaceutical/Drug Registration in Taiwan

The pharmaceutical/drug market in Taiwan is about $4.5 billion. The Department of Health (DOH) has established the Bureau of Pharmaceutical Affairs (BPA) to handle pharmaceutical regulation. The DOH is Taiwan’s equivalent of the U.S. FDA. The BPA must approve all pharmaceuticals imported to Taiwan before they can be marketed. The pharmaceutical registration process in Taiwan has historically been lengthy and slow, especially for foreign manufacturers.

Unlike other countries, applicants must submit their Plant Master File before applying for drug registration. Consultations with the DOH may also be needed to determine if local clinical trials or a bridging study is required.

However, the DOH has recently worked to simplify the regulation and review process, to allow a larger amount of high quality drugs to enter the Taiwanese market. For example, they have adopted PIC/S for the PMF. In some cases, U.S. or EU approvals can be substituted for local requirements. American pharmaceutical companies and trade associations took a large part in negotiations with the Taiwanese government to encourage a more streamlined process, opening the market further to foreign drug manufacturers.

PBM can act as an In-Country Caretaker (ICC) and register the foreign pharmaceutical/drug company's products in their own name.

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

Taiwan Drug Registration and Regulatory Issues (webcast for sale)
Taiwan: New Pharmaceutical Regulatory Trends