The State Administration for Market Regulation ("SAMR") has recently drafted the Good Manufacturing Practice for Chinese Crude Drugs (Revised Draft for Comment) (the "Draft for Comment") to seek public opinions by August 22, 2018.
The Draft for Comment not only emphasizes the focused management on critical processes that have a material impact on the quality of Chinese crude drugs, but also attaches importance to the whole-process refined management and the responses to public concerns; also, it proposes a requirement for the first time that the entire manufacturing process of Chinese crude drugs shall be made traceable. In addition, a new chapter titled "Quality Inspection" is added to the Draft for Comment to specify the inspection qualifications, reservation of samples and other requirements; another newly-introduced chapter entitled "Self-inspection", stipulates that enterprises shall monitor and audit the quality on their own. Moreover, the Draft for Comment brings the formulation of technical norms and quality standards to an earlier stage and turns them to be the premise and basis for initiating the base construction and management; also, the application of emerging technologies and new equipment is encouraged, and enterprises are inspired to apply modern information technologies to establishing the traceability system. Furthermore, the Draft for Comment highlights the protection of the ecological environment and animals, and proposes the idea for the first time that attention shall be paid to rights and interests of animals bred for medical uses.