context: The number of innovative drugs has been on the rise under an improved approval system but they are overly concentrated in certain areas. Their clinical value, safety and accessibility will be further scrutinised. Drug supervision will further improve to grow the industry to be internationally competitive, especially led by the few firms with higher R&D capacity.
National Medical Products Administration released ‘5-year plan on national drug safety and high-quality development’ on 30 Dec 2021, specifying
- goals by 2035
- having an internationally competitive drug supervision system
- significantly improving whole life-cycle drug safety management and approval efficiency
- significantly improving drug safety, efficacy and accessibility as well as treatment for major and rare diseases
- becoming a pharma powerhouse of innovation and R&D based on a cluster of leading companies
- goals by end of 5-year plan
- improving the supervision environment to support industry high-quality development
- improving approvals, especially for clinically-needed innovative drugs
- vaccine supervision reaching advanced international standards
- new strides in the innovative development of TCM (traditional Chinese medicine)
- more professional talent
- better technological support
- major tasks
- implementing drug safety whole-process supervision
- tightening supervision in research, production, operations and online sales
- supporting industry upgraded development
- improving standards system
- implementing pilots for innovative supervision
- accelerating approval of key products
- improving drug safety management system
- improving legislation and supervision system at different levels
- strengthening collaboration amongst different authorities
- deepening approval system reform
- increasing support for innovation R&D
- improving bioequivalence evaluation for generic drugs
- strengthening vaccine supervision
- improving evaluation, supervision and whole life-cycle management
- promoting TCM development
- building an evaluation and approvals system suitable for TCM
- strengthening technical support and quality supervision
- increasing technical policy support
- strengthening evaluation and inspection capacity
- improving pharmacovigilance system and cosmetics risk supervision
- strengthening human resources
- aiming to have as many high-quality evaluation professionals as other strong pharma nations
- strengthening smart supervision and management
- improving drug traceability system, whole life-cycle digital management and internet+ services
- strengthening emergency response and capacity
- implementing drug safety whole-process supervision