Regulatory updates on China, December 2019

Dr. C. Benson Kuo and his team are documenting the evolving regulatory landscape in China! For general information on Education Initiatives, click hereHighlight posted on December 29th, 2019

70 New Drugs to be Included in China’s National Drug List

According to the China National Healthcare Security Administration, 70 new drugs will be included in China’s national drug list with their prices slashed by 60.7% on average. The price of three new drugs for hepatitis C will be reduced by an average of 85% and the price of cancer and diabetes drugs will be reduced by 65% on average. Most additions are new drugs with high clinical value used to treat multiple diseases including cancer, diabetes and tuberculosis. The drug price reduction and medical insurance reimbursement are expected to greatly ease patients’ financial burden.

NMPA Finds Fault with Quality Management Systems at Vaccine Facilities

The China National Medical Products Administration (NMPA) has identified a need for manufacturers of vaccines to improve their quality management systems during an industry-wide inspection program. Owing to a series of scandals, quality practices of Chinese vaccine manufactures remain in the spotlight. To curb data fabrication and improper storage of vaccines, Chinese authorities sent 197 inspectors, divided into 36 groups, to inspect vaccine manufacturers. The inspectors found that all companies complied with Good Manufacturing Practice and were not engaging in illegal activities. However, there is still scope to improve quality management systems and strengthen quality control and document management.

NMPA will establish a Vaccine Traceability System

The China National Medical Products Administration (NMPA) issued notice on the construction of a vaccine traceability system. According to the notice, Beijing, Tianjing, Shanghai, Jiangsu, Hainan and Chongqing will take the lead in constructing a vaccine traceability system and accomplish connection with the collaborative platform before December 31, 2019. Vaccine information including production, trade and application will be submitted into the collaborative platform before January 31, 2020. Other provinces are required to establish connection with the vaccine traceability system by March 31, 2020, so that the whole process of vaccine market can be verified and regulated.

TCM Herb becomes ISO Certified

Dried Angelica sinensis root, an herb commonly used in Traditional Chinese Medicine (TCM) prescriptions has been issued an international standard certified by the International Organization for Standardization (ISO). The formulation and promulgation of the international standard can help ensure the quality and safety of TCM in international trade, said Xu Hong, a researcher at the Shanghai University of Traditional Chinese Medicine, who participated in the ISO certification project. In 2009 the ISO approved China’s proposal to formulate a standard for Angelica sinensis root, and nominated experts from China, Canada, Australia, Japan and the Netherlands to join the project team.