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China's NMPA to establish market exclusivity for pediatric, rare disease drugs
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On September 20, Yang Sheng, Deputy Commissioner of China's National Medical Products Administration (NMPA), announced at a State Council Information Office press conference that the agency will implement a drug experimental data protection system and establish market exclusivity periods for pediatric drugs, rare disease treatments, and other areas. This move aims to better safeguard corporate research and development investment. The NMPA will also improve early-stage communication and consultation mechanisms for R&D, providing enhanced pre-guidance for innovative drugs targeting new targets or employing new mechanisms to help companies avoid detours. Additionally, the 'Spring Rain Action' initiative for converting clinical innovations into medical devices will be expanded, and guidelines for clinical trials and review will be formulated in cutting-edge fields such as brain-computer interfaces to pave the way for future industries.
Source report
Beijing, September 20 — Yang Sheng, Deputy Commissioner of the National Medical Products Administration (NMPA), announced at a press conference hosted by the State Council Information Office that the agency will implement a drug experimental data protection system and establish market exclusivity periods for pediatric drugs, rare disease treatments, and other key areas.
The move is intended to provide stronger safeguards for corporate research and development investment.
Key Measures Announced
- Market Exclusivity Periods: New exclusivity frameworks will be introduced for pediatric drugs and rare disease treatments.
- Improved R&D Communication: Early-stage consultation mechanisms will be enhanced, with better pre-guidance for innovative drugs targeting new mechanisms or novel targets, helping companies avoid unnecessary detours in development.
- Expanded "Spring Rain Action": The initiative to convert clinical innovations into medical devices will be broadened.
- Cutting-Edge Guidelines: New clinical trial and review guidelines will be developed for emerging fields such as brain-computer interfaces, paving the way for future industries.
Source
财联社Eastern
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China’s NMPA to grant market exclusivity for pediatric and rare disease drugs