Yang Sheng, deputy director of the National Medical Products Administration, recently stated that China's pharmaceutical industry is currently ranked second in the world, with innovative drugsThe number of projects under research accounts for about 30% of the world's total.
Yang Sheng said that to complete the goals and tasks of the 14th Five-Year Plan with high quality and ensure the safety and effectiveness of people's use of medicines, work should be mainly carried out in three aspects: comprehensively strengthening the bottom line of drug safety, supporting the high-quality development of the pharmaceutical industry throughout the entire chain, and fully guaranteeing the people's drug needs.
In terms of building a solid bottom line for drug safety in all aspects, my country has strengthened dynamic supervision covering the entire life cycle of drugs, established and improved a drug safety risk consultation mechanism, focused on key links such as online drug sales, contract drug production, and clinical trial management, focused on key products such as vaccines and blood products, and focused on key areas such as rural areas and urban-rural fringe areas, to achieve normalized and long-term drug safety risk investigation, analysis, and disposal.
In terms of supporting the high-quality development of the pharmaceutical industry throughout the entire chain, we will continue to deepen the reform of the review and approval system, establish four accelerated channels for breakthrough therapeutic drugs, conditional approval, priority review and approval, and special approval, and implement "early intervention, one policy for each company, full-process guidance, and coordinated research and approval" for key varieties.
To fully cover and ensure the people's medication needs, we will further optimize the review and approval procedures for clinically urgently needed new drugs from overseas, allowing Chinese patients to benefit from the latest global drug research and development results earlier and faster. We will also accelerate the launch of pediatric medications and drugs for rare diseases. Since the 14th Five-Year Plan, a total of 387 pediatric drugs and 147 drugs for rare diseases have been approved for marketing, effectively meeting the medication needs of key populations.
Yang Sheng said that the next step will be to continue to comprehensively deepen drug regulatory reforms and make unremitting efforts to ensure high-level drug safety, promote high-quality development of the pharmaceutical industry, and benefit the people's high-quality life.
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By editor