Pharmaceutical and Drug Registration in Taiwan
Is your company interested in registering your pharmaceutical or drug in Tawian?
Registering a medical product in your company's name can be time consuming, but the specialists at Pacific Bridge Medical can help you streamline the process. Acting as your In-Country Caretaker, we can help your company navigate the regulation process and get your product ready for distribution.
Keep reading to find out more about the pharmaceutical and drug registration process and learn how our team can help you expand your global presence.
Entering the Taiwan Pharmaceutical and Drug Market
The pharmaceutical and 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.
Taiwan has a Drug Master File (DMF) system, which allows foreign drug manufacturers to register their information concerning the manufacturing and quality methods of their APIs directly to the TFDA authority. The DMF system helps protect companies’ intellectual property.
Speak with A Specialist Today
Retain the rights to your product with the help of international medical consultants who have yearsPBM 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.
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- 2012 Taiwan Medical Device Regulatory Update
- 2010 Taiwan Drug Registration and Regulatory Issues
- 2008 Managing Asian Cultural/Business Diversity
- 2007 Update on Taiwan's Medical Device Markets
- 2006 Taiwan Medical Device Regulations
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