自2015年起,国务院和国家发改委、科技部、国家知识产权局等部门发布多项政策文件,支持和鼓励制剂的创新与开发。国家药监部门陆续出台相关注册审批政策性文件,推动创新制剂各项政策的落地和执行。创新制剂的研发投入少、周期短、风险低、市场前景广阔,是仿制药“4+7”带量采购政策之后医药企业未来重要的产品开发方向。固体制剂作为创新制剂开发的重要技术平台,可通过先进技术手段,实现长效、缓控释、肠道靶向、多重递药等功能,解决药物在临床使用中的局限性,达到疗效更优、副作用更小、患者顺应性更好的临床目标,满足医患双方的需求。
<<Since 2015,the State Council,National Development and Reform Commission,the Ministry of Science and Technology,and National Intellectual Property Administration have issued a number of policy documents to support and encourage the innovation and development of preparations. National Medical Products Administration has successively issued relevant registration and approval policy documents to promote the implementation of various policies related with innovative preparations. With low R&D investment,short cycle,low risk,and broad market prospects,innovative preparations become an important product development direction for pharmaceutical companies under the “4+7” volume-based procurement policy for generic drugs. As an important technical platform for the development of innovative preparations,solid preparations can achieve long-term effect,sustained and controlled release,intestinal targeting,multiple drug deliveries and other functions through advanced technical means,which solve the limitations of drugs in clinical use,and achieve the clinical goals of better efficacy,fewer side effects and better patient compliance to meet the needs of both doctors and patients.
<<Keywords: | Policy SupportInnovative PreparationsSolid PreparationsRegistration and ApplicationClinical Advantages |