药品、医疗器械和化妆品（以下简称药品）安全关系人民群众的身体健康和生命安全，是重大的政治问题、民生问题、经济问题和社会问题。随着技术创新的不断涌现和医药产业的快速发展，药品监管工作面临着许多前所未有的机遇与挑战。保障高水平安全、促进高质量发展、推进高效能治理，需要认真思考药品监管的基本规律和运行机制，阐释“为何监管、为谁监管、监管什么、怎样监管、靠谁监管”五大课题。多年的监管实践启示，确立“产品为王、健康为魂、安全为上、质量为金、风险为要、责任为重、体系为纲、能力为根”的药品监管一般规则，重点强化产品是核心、是关键，健康是根本、是精髓；安全是首位、是底线，质量是基石、是命脉；风险是靶心、是焦点，责任是刚性、是铁律；体系是总纲、是统领，能力是根本、是基础，将有利于明确药品监管工作的价值导向、目标要求、重点任务、关键路径等，进一步提升监管工作的科学化、法治化、国际化和现代化水平，更好地保护和促进公众健康。

The safety of drugs， medical devices， and cosmetics （hereinafter collectively referred to as drugs） are related to people's health and safety. It is therefore a major issue of politics， public welfare， the economy， and the society. With the continuous emergence of technological innovation and the rapid development of pharmaceutical industry， drug regulation is confronted with unprecedented opportunities and challenges.To ensure high-level safety， promote high-quality development， and advance efficient governance， we must give serious thought to the underlying principles and operating machanisms of drug regulation， and to address the five fundamental questions： why to regulate， for whom to regulate， what to regulate， how to regulate， and by whom to regulate. Years of regulatory practices suggest the value of establishing a set of general rules for drug regulation-product as the king， health as the soul， safety as the top priority， quality as the gold， risk as the key， responsibility as the emphasis， system as the outline， and capability as the foundation. Strengthening these priorities， recognizing that product is the core and the key， health is the foundation and the essence， safety is the foremost requirement and the bottom line， quality is the cornerstone and the lifeline， risk is the target and the focus， responsibility is the rigid and binding principle， system is the overall framework and the coordinator， capability is the fundamental basis， will help clarify the value-orientation， goals and requirements， key tasks and critical pathways of drug regulation. It will also further enhance the scientific， law-based， internationalized， and modernized level of regulatory work， thereby better protecting and promoting public health.