China FDA released an interim document stating that innovative therapeutic biologics will receive 12 years of data exclusivity from the date of marketing authorization, during which "the same types of drugs" can not receive approval. The agency is soliciting opinions on the draft until May 31.
The draft document also states regulatory applications for innovative drugs and biologics submitted after a company has applied for approval in other countries will receive one to five years of protection. Companies will not receive data protection if they apply for approval in China later than six years after applying in another country. Companies that submit Chinese regulatory applications without clinical trial data for Chinese patients will have their protection periods reduced by 75%. Applications based on overseas data supplemented with Chinese clinical trials will have their protection periods reduced by 50%.
In addition, the document reiterated that innovative drugs will receive six years of data exclusivity. The China State Council announced that rule on April 12 as part of its efforts to “strengthen the protection of intellectual property” and increase patients’ access to medications. According to Katherine Wang, a life sciences regulatory lawyer in China, the State Council’s measure would prevent generic manufacturers from referring to CMC data in the original drug application to establish equivalence (see BioCentury Extra, April 17).