In accordance with the relevant provisions of the "Pharmaceutical Administration Law of the People's Republic of China", "Pharmaceutical Non-clinical Research Quality Management Practices" (GLP) and "Pharmaceutical Non-clinical Research Quality Manage...

        In order to further standardize and guide the research and development and evaluation of biosimilars, and provide technical reference for industry, researchers and regulatory agencies, the Center for Drug Evaluation has formulated the "Technical Guidelines for the E...

        According to the "Announcement of the State Drug Administration on Issues Concerning the Implementation of the Measures for the Administration of Drug Registration" (No. 46, 2020), in order to promote the supporting work of related documents, under the deploy...

        In order to further standardize and guide the research and development and evaluation of biosimilars, and provide technical reference for industry, researchers and regulatory agencies, the Center for Drug Evaluation has formulated the "Technical Guidelines for the E...

Notice of the General Office of the National Health and Family Planning Commission on Issuing the Technical Management Specifications for Hematopoietic Stem Cell Transplantation (2017 Edition) and other 15 "restricted clinical application" medical technical management specifications...