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China has granted a six-year protection period for clinical trial data on innovative drugs, the National Medical Products Administration (NMPA) said.
The six-year protection applies to innovative drugs and originator drugs, calculated from the date of drug registration. Improved new drugs receive four years of data protection, and first generic drugs receive three years, according to a guideline issued by the administration. Ordinary generic drugs and biosimilars are not granted data protection.
During the protection period, the administration will neither accept nor approve any marketing application filed by other applicants that relies on the protected data without the holder's consent.
Clinical trial data – typically requiring huge investment and more than a decade of research – have not been covered under the patent regime. The new rules are designed to prevent "free-riding" applications and reward genuine innovation.
The administration said the newly implemented trial data protection system, working in tandem with the patent protection system, will provide "dual protection" for new drug research and development in China, enabling enterprises that have invested heavily in original data on safety, efficacy and quality control to receive returns and fostering a virtuous cycle in the country's innovative drug ecosystem.
https://chinaipr.mofcom.gov.cn/article/topnews/202605/1996295.html
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