Recently, the newly revised "Implementation Regulations of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Regulations") have been officially released and will take effect from May 15. This marks the first comprehensive revision of the Regulations in 23 years, with over 90% of the clauses being modified.
A key focus of this revision is the expansion of the drug trial data protection system and the first-time introduction of a drug market exclusivity period system, significantly strengthening the protection of pharmaceutical intellectual property rights.
To fully protect the medication rights and interests of special populations, the Regulations extend the drug market exclusivity period system to pediatric drugs and drugs for rare diseases. Eligible pediatric drugs will be granted a market exclusivity period of up to 2 years, while eligible drugs for rare diseases will receive a market exclusivity period of up to 7 years.
Furthermore, the state will implement protection for undisclosed trial data and other data independently obtained and submitted by marketing authorization holders of drugs containing new chemical constituents and other eligible drugs. The protection period for this data shall not exceed 6 years from the date of drug registration.
It was noted that last year, the National Medical Products Administration (NMPA) had already released two draft documents for public comment: the "Measures for the Implementation of Drug Trial Data Protection (for Trial Implementation)" and its accompanying working procedures, aiming to strengthen data protection for innovative drugs, improved new drugs, and the first approved generic drugs.
Experts stated that during the data protection period, innovative drug companies can obtain reasonable returns, which aids in sustaining R&D and innovation. After the data protection period expires, generic drug manufacturers can utilize the originator drug's data to simplify their market approval applications, helping to reduce drug prices.
"During the market exclusivity period, other companies cannot apply for approval of the same drug based on the originator's data, which secures the innovator's expected market returns," said a domestic biopharmaceutical company executive. "Protecting the original data obtained by pharmaceutical companies through massive R&D investments is another crucial system for encouraging innovation. It not only provides a clear payback period for innovative drugs but also reserves space for the subsequent development of generic drugs, especially complex generics."
During the "Two Sessions" last year, Zhu Tongyu, a member of the National Committee of the Chinese People's Political Consultative Conference (CPPCC) and Vice President of Shanghai Medical College of Fudan University, had called for the establishment of a drug trial data protection system that matches the encouragement of innovation to ensure companies' sustained innovative capabilities.
Zhu Tongyu explained that new drug R&D is a process characterized by high risk, substantial investment, and long cycles. Obtaining data on a drug's efficacy and safety requires long-term, progressively expanding clinical trials. He suggested further extending the current protection period for domestic innovative drugs, which is typically three to five years.
Lu Xianping, founder and chairman of Shenzhen Chipscreen Biosciences Co., Ltd., stated, "These regulatory clauses are what the industry has long hoped the NMPA would revise. It's encouraging to see them gradually being implemented now, which gives us innovative drug R&D companies great confidence. Particularly, the mention in the Regulations of granting a certain number of years of market exclusivity to eligible drugs is certainly positive for the development of innovative drugs."
A senior executive from a multinational pharmaceutical company commented that in European and American markets, the data protection period for innovative drugs is typically 5 to 7 years. The new regulations' protection of drug trial data will, on one hand, encourage companies to invest more in developing innovative products with clinical value, and on the other hand, play a positive role in standardizing drug genericization and help improve the quality of generic drugs.