Development and Enlightenment of FDA Good Guidance Practice

OBJECTIVE To comprehensive understand the drafting background, basic structure, main features, operational effectiveness and improvement direction of the Good Guidance Practice(GGP), to provide reference for China’s future development of drug regulatory guidelines and management standards. METHODS Studied on the content related to GGP in US Federal Register as well as other government documents, and analyzed its formation and development environment from the US administrative legal system by literature research and comparative jurisprudence. RESULTS The born of the GGP relied on the social forces, the contents always emphasized on the extension definition of guidance documents, the non-legal mandatory attributes, the public participation, and the channels of notices and comments. What’s more, social multi-governance was core principle of the GGP. In recent years, the FDA had also put forward new requirements for the bureaucratic efficiency of formulating guidance documents. CONCLUSION China can learn classification, public participation, bureaucracy cooperation mechanism from the GGP; Considering different legal systems in different countries, it should also integrate the guidance documents into China’s legal constitution.