摘要
Abstract
This article examines the necessity,systemic nature,and practical significance of pharmaceutical regulatory compliance in China.It first delineates the conceptual boundaries and functional distinctions among three levels of legislation,regulation,and compliance,and introduces the theoretical framework of"regulated self-regulation"to clarify the institutional essence of compliance.It further defines the scope and connotation of pharmaceutical regulatory compliance and distinguishes it from general corporate compliance,business ethics compliance,and anti-corruption compliance.Building on this foundation and from a multi-dimensional perspective of regulatory capacity,the article analyzes the major challenges currently facing the development of China's pharmaceutical regulatory compliance system,including the deepening transition from outcome-oriented regulation to process-oriented regulation,the institutionalization of enforcement capacity and compliance culture,the optimization of central-local allocation of regulatory authority and risk-based classified supervision,and the growing demand for international compliance alignment driven by the globalization of Chinese pharmaceutical enterprises.The article then systematically reviews the institutional logic of major international regulatory authorities,such as the U.S Food and Drug Administration(FDA)and the European Medicines Agency(EMA),with respect to system architecture,functional division,accountability chains,and trust-based infrastructure governance mechanisms.It also draws on the experience of China's IPO regulatory regime as a cross-sector reference for front-end supervision and professional intermediary participation.Finally,in light of the newly revised Regulations for the Implementation of the Drug Administration Law of the People's Republic of China(2026)and the practical needs arising from China's pharmaceutical innovation and internationalization,the article proposes directional recommendations for establishing a structural pharmaceutical regulatory compliance ecosystem in China.关键词
药品监管合规/受规制的自我规制/风险分级分类监管/药品管理法实施条例/国际比较Key words
pharmaceutical regulatory compliance/regulated self-regulation/risk-based classified supervision/Regulations for the Implementation of the Drug Administration Law/international comparison分类
医药卫生
