Data Exclusivity for New Medicines Passed the Final Read in the Legislative Yuan Five Years of Exclusivity Period.

Data Exclusivity for New Medicines has passed the final read in Legislative Yuan.

Any new medicine consists of a new ingredient will have an exclusivity period of five years after the certificate is issued.  Within three years after receiving a permission to enter the domestic market, new medicines must be applied to the Department of Health for inspection registration so as to be entitled to the exclusivity.

 

Other than protecting patent, the intellectual property rights also provide a certain

period of protection to the relevant data, such as clinical experiment and etc.  Article 40ter of the amended Pharmaceutical Affairs Law stipulates a five-year exclusivity for new medicines with new ingredients after a certificate is issued.  Without authorization or consent, other pharmaceutical manufacturers cannot quote the data to apply for inspection registration.  However, the generic medicines (whose patent term has expired) manufacturers may apply for permission starting from the third year, instead of after the five-year data exclusivity.  Thus, as soon as the five-year data exclusivity expires, the medicines may enter the market.  (2005.1)

CYJ/CHT