摘要
Abstract
Drug safety is a core issue directly affecting public health,economic development,and national strength,while innovation serves as the driving force behind pharmaceutical advancement and industrial transformation.As China enters a critical phase in its transition from a major pharmaceutical manufacturer to a global pharmaceutical leader,it faces ongoing challenges such as incomplete policy mechanisms,limited regulatory capacity,insufficient corporate accountability,and underdeveloped multi-stakeholder governance.This paper explores how to strike a balance between pharmaceutical innovation and safety from a regulatory perspective,emphasizing its strategic significance for the industry's future.It analyzes the key manifestations of current challenges and proposes six strategies:upholding a people-centered approach to health;strengthening regulatory science and optimizing policy;adopting a risk-based,adaptive review and approval mechanism;enhancing regulatory capacity and promoting multi-party collaboration;incentivizing innovation and self-discipline among enterprises;and guiding public participation in supervision.Moving forward,systematic reforms are essential to establish a robust,life-cycle-based regulatory system framework that balances safety assurance with innovation vitality,promotes high-quality development of the pharmaceutical industry,and supports the implementation of the Healthy China Initiative.关键词
创新/安全/平衡/药品监管/医药产业Key words
innovation/safety/balance/drug regulation/pharmaceutical industry分类
医药卫生
