Abstract:

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.

Key words: 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,  capability as the foundation