Recently, the National Medical Products Administration ("NMPA") has drafted six documents including the Qualification Accreditation Conditions and Inspection Work Practices for Drug Inspection Institutions (the "Practices"), the Inspection Work Practices for Traditional Chinese Medicines and the Inspection Work Practices for Chemical Medicines, to solicit comments from the public before August 31, 2020.
The Practices consist of 13 chapters, including the organizational structure, personnel, quality management system, facilities and environment, contract review and sample management, inspection and quality control, code of conduct and legal liability. According to the Practices, a drug inspection institution shall have more than 12 persons directly engaged in inspection. In particular, the percentage of persons with the intermediate or above technical title of pharmacy or equivalent capability shall exceed 25%. The Practices also require that drug inspection institution shall not take part in any drug production or operation activity and shall not recommend or supervise the production or sales of any drug in its own name. Furthermore, any person from a drug inspection institution shall not take part in any drug production or operation activity, or work for two or more drug inspection institutions at the same time.