5 May, 2018
Under the amended Pharmaceutical Affairs Act, there is:
(a) three-year data exclusivity for the holder of drug approvals of new drugs with new ingredients, and
(b) two-year data exclusivity for the holder of drug approvals of newly added indications or change of indications if the application for such drug is filed with MOHW within 2 years after it obtains the approval in other foreign countries.
Accordingly, a generic drug manufacturer shall not allowed to assert or rely on any data stated in the application for an approved drug filed by another (“Data”) when applying for drug registration within the exclusivity period, unless the holder of the drug approval so consents.
The data exclusivity period is counted from the issuance date of the aforesaid drug approvals.
Although one may assert or rely on the Data upon the expiration of the data exclusivity period, MOHW will not issue the drug approval until the next day of the expiration of:
(a) five years for new drugs with new ingredients and for a drug with newly added or change of indications if the clinical trial for such indication is conducted in Taiwan, or
(b) three years for a drug with newly added or change of indications, after the issuance date of the new drug approval whose Data is asserted or relied on.
In the event that a marketing approval has already been granted for new drugs with new ingredients in a foreign country, the three-year data exclusivity shall only apply when the application for drug registration of said new drug is filed with the central health authority (i.e., the Ministry of Health and Welfare) within 3 years from the issuance date of the foreign marketing approval.
For further information, please contact:
Wendy Chen, Tsar & Tsai Law Firm
law@TsarTsai.com.tw
