The Shanghai medical products administration has released the “Measures for the Management of Key Quality and Safety Management Personnel of Drug Production and Operation Enterprises in Shanghai (Trial)”. These measures aim to tackle current issues in managing key personnel responsible for drug quality and safety within enterprises and to bolster the quality management of drug production and operations in Shanghai. The document is set to be effective until February 28, 2026, and applies to drug marketing authorization holders (MAHs) who either produce drugs in-house or outsource manufacturing, contract manufacturing organizations (CMOs), raw material manufacturers, and traditional Chinese medicine (TCM) production companies.
The Measures mandate that pharmaceutical companies establish and execute systems and mechanisms for the training, assessment, and evaluation of key management personnel. Companies must organize or delegate pre-job and ongoing training for their key management staff to institutions capable of providing such education and must maintain records of training and assessments. The curriculum covers drug laws, regulations, policies, job responsibilities, and professional knowledge and skills.
Key management personnel are expected to have a comprehensive understanding of their duties, be well-versed in job requirements, actively engage in relevant training, and continuously update their knowledge. Any changes in key management personnel, excluding the drug vigilance officer, must be registered through the “Government Online-Offline Shanghai” platform within 30 working days of the change. For alterations in the information of the drug vigilance officer, updates must be registered on the https://www.adrs.org.cn/ within 30 days of the change. Vaccine MAHs are required to report changes in their production manager, quality manager, quality authorized person, and other key management personnel to the municipal medical products administration within 15 working days of any change.
The Measures also outline regulations for key management personnel in areas such as commissioned production and sales, health management, and authorization management. The municipal medical products administration and district market supervision bureau are tasked with enhancing public welfare promotion and training on relevant drug management laws, regulations, policies, and other knowledge for key management personnel and enterprise practitioners. The municipal medical products administration will also be responsible for strengthening the training and assessment of key management personnel of commissioned production MAHs.- Flcube.com
