Taiwan Pharmaceutical Registration and Approval

The Taiwanese Ministry of Health and Welfare (MOHW) set up the Taiwan Food and Drug Agency (TFDA) to enforce pharmaceutical regulations within Taiwan. For foreign drug companies to sell their pharmaceutical products in Taiwan, they are required to obtain TFDA registration approval, which is comparable to the mandatory approval of the U.S. FDA. Taiwan drug registration approval from the TFDA is necessary for the manufacturing and import of pharmaceuticals, and the requirements for approval differ between new drugs and generic drugs.

For new drugs, the Taiwan pharmaceutical registration process involves a review of the quality of raw materials and the manufacturing processes, as well as the toxicological, animal, and pharmacological data to confirm the proposed mechanism of action of the drug and any potential adverse reactions. Additionally, data from animal and human clinical trials are evaluated. Clinical trial results are required to prove the safety and effectiveness of the drug. Most foreign drug companies can use overseas clinical data for their drug registration in Taiwan. For generic drugs, the focus of the registration approval process is on ensuring that the generic drug is identical in quality to its reference listed drug.

To register drugs in Taiwan, it is necessary to provide all compendial test methods for excipients, drug substances, and drug products. Moreover, the drug market in Taiwan mandates a secure commercial supply chain, which necessitates the provision of stability data for three batches over six months at the time of dossier submission, and for 12 months during the review process. Furthermore, one of the commercial supply chain batches must have executed batch records.

In the case of biologics, it is necessary to present an executed batch record for the drug substance, as well as COAs for the drug product, drug substance, excipients, and packaging components.

There are no restrictions on the number of sites for biologics manufacturing or packaging. Nevertheless, there is a limitation of only one site permitted for drug product packaging and manufacturing.

Both drug products and drug substances need a process validation report. Finally, a GMP inspection will be mandated if the drug manufacturing site is not located in a country that has entered into a mutual recognition agreement (MRA) with Taiwan, or if this country does not have a Pharmaceutical Inspection Cooperation Scheme membership.

In addition, the TFDA offers several programs, such as accelerated approval pathway, priority review pathway, and abbreviated review pathway, which aim to speed up the review and approval process of new drugs that target serious or life-threatening diseases where there is a lack of effective treatment options available.

To learn more about how PBM can help you register your drug products in Taiwan, please contact us.