China NMPA to establish market exclusivity for pediatric and rare disease drugs
On September 20, China's NMPA Deputy Commissioner Yang Sheng announced at a State Council press conference that the agency will implement a drug trial data protection system and establish market exclusivity periods for pediatric and rare disease drugs to protect R&D investment. The NMPA also plans to expand the "Spring Rain Action" for medical device innovation, develop guidelines for brain-computer interfaces, and support the creation of 3-5 internationally competitive biomedical industry clusters.
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China to establish market exclusivity periods for children's and rare disease drugs, says NMPA official
On September 20, Yang Sheng, deputy director of China's National Medical Products Administration (NMPA), announced at a State Council press conference that 59 innovative drugs and 51 innovative medical devices have been approved in China this year. For the '15th Five-Year Plan' period, the NMPA will focus on three areas: stimulating R&D vitality, promoting manufacturing upgrades, and improving drug accessibility. Yang stated that a drug trial data protection system will be implemented, and market exclusivity periods will be established for children's medicines and rare disease drugs to protect corporate R&D investment. The NMPA will also expand the 'Spring Rain Action' for medical device innovation, targeting future sectors like brain-computer interfaces. The agency plans to support the development of 3-5 internationally competitive biomedical industry clusters in regions including Beijing-Tianjin-Hebei, the Yangtze River Delta, the Greater Bay Area, and the Chengdu-Chongqing economic circle. Foreign investment in original drugs and high-end medical equipment production in China will be encouraged, along with Chinese companies going global. For clinically urgent needs, the NMPA will streamline review and approval timelines and implement special programs for pediatric oncology and rare disease drug development.
Read sourceChina's NMPA to Establish Market Exclusivity Periods for Pediatric and Orphan Drugs
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 clinical data protection system and establish market exclusivity periods for pediatric drugs, orphan drug therapies, and other relevant areas. This policy aims to provide greater assurance for corporate research and development investment. The NMPA will also improve communication mechanisms for early-stage R&D, enhancing pre-submission guidance for innovative drugs targeting new mechanisms or novel targets to help companies avoid unnecessary detours. Additionally, the 'Spring Rain Action' initiative for converting clinical innovations into medical devices will be expanded. The agency will formulate guidelines for clinical trials and regulatory review in cutting-edge fields such as brain-computer interfaces, paving the way for future industries.
Read sourceChina's NMPA Plans Market Exclusivity for Pediatric and Rare Disease Drugs to Protect R&D
On September 20, Yang Sheng, Deputy Director 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 and orphan drugs (rare disease treatments). The goal is to provide greater assurance for companies' research and development investments. The NMPA also plans to improve communication mechanisms during early-stage R&D, offering enhanced pre-guidance for innovative drugs with new targets and mechanisms to help companies avoid detours. Additionally, the 'Spring Rain Action' initiative for converting clinical innovation outcomes into medical devices will be expanded. The agency will formulate clinical trial and review guidelines in cutting-edge fields such as brain-computer interfaces to pave the way for future industries, according to the Securities Times.
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China's NMPA to Establish Market Exclusivity for Pediatric and Rare Disease Drugs
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.
China's NMPA to Establish Market Exclusivity Periods for Pediatric and Rare Disease Drugs
On September 20, at a press conference hosted by the State Council Information Office, Yang Sheng, Deputy Director of China's National Medical Products Administration (NMPA), announced plans to implement a drug clinical data protection system and establish market exclusivity periods for pediatric drugs, rare disease medications, and other fields. This initiative aims to provide greater assurance for corporate research and development (R&D) investment. The NMPA will also improve early-stage communication and consultation mechanisms for R&D, enhancing pre-submission guidance for innovative drugs targeting new targets or employing novel mechanisms to help companies avoid unnecessary detours. Additionally, the 'Spring Rain Action' initiative for converting clinical innovations into medical devices will be expanded, and guidelines for clinical trials and regulatory review will be formulated in cutting-edge fields such as brain-computer interfaces, paving the way for future industries.
Read sourceChina's NMPA to Establish Market Exclusivity for Pediatric and Rare Disease Drugs to Protect R&D Investment
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 data protection system for pharmaceutical experiments and establish market exclusivity periods for pediatric drugs and rare disease treatments. These measures aim to provide greater assurance for corporate research and development investment. The NMPA will also improve communication mechanisms during early-stage R&D, offering enhanced pre-emptive guidance for innovative drugs with new targets and mechanisms to help companies avoid detours. Additionally, the 'Spring Rain Action' initiative for converting clinical innovations into medical devices will be expanded. The agency will formulate clinical trial and review guidelines in cutting-edge fields such as brain-computer interfaces to pave the way for future industries, as reported by People's Finance News.
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