Study on Sustainable China’s Pharmaceutical Innovation Ecosystem

Abstract

In recent years, China's pharmaceutical innovation has achieved remarkable results, with strong growth in innovative drug development driven by policy, talent, and investment. Through more than 20 years of development, China has initially established a relatively complete drug regulatory system of laws and regulations. At the same time, China's pharmaceutical innovation is also facing many challenges, including policy, talent, and investment. However, compared to the world's leading countries, there is still a gap in the quality of innovation in China's currently marketed pharmaceutical innovation ecosystem. By implementing the concept of scientific and risk-based assessment, this paper provides a comprehensive analysis of the current state of China's pharmaceutical innovation ecosystem and proposes future directions for development, including improving laws, regulations, policies, and technical guidelines promptly; improving the review decision-making mechanism and priority review mechanism to encourage the review of innovative drugs; optimising the organisational structure, approval process and resource allocation of regulatory bodies in a demand-driven manner to shorten the review time; and strengthening the clinical data.