Beijing, Tianjin and Hebei will share regulatory information on medicine

Dec. 26, 2019

Beijing, Tianjin and Hebei will share regulatory information on medicine

In the future, the drug regulatory departments in Beijing, Tianjin and Hebei will unify the licensing review, registration, licensing and regulatory standards under the new pharmaceutical industry, new format, new technology and new mode, jointly study the credit rating evaluation system, jointly issue the supervision and inspection rules for mutual inspection and mutual evaluation, and promote the supervision of drugs, medical devices and cosmetics in Beijing, Tianjin and Hebei To manage the integrated and coordinated development in a higher level, deeper level and wider field, and jointly build a public safety drug use equipment barrier. In order to further improve the safety supervision mechanism of drugs, medical devices and cosmetics in Beijing, Tianjin and Hebei, and share regulatory resources, today, the three drug administrations of Beijing, Tianjin and Hebei jointly held a seminar on the development of coordinated supervision of drugs, medical devices and cosmetics in Beijing, Tianjin and Hebei. At the meeting, the three parties signed the Beijing Tianjin Hebei regional linkage cooperation framework agreement on pharmaceutical and medical devices and cosmetics, the Beijing Tianjin Hebei regional cooperation agreement on pharmaceutical safety collaborative supervision, and the Beijing Tianjin Hebei regional cooperation agreement on scientific collaborative supervision of medical devices.

 

The three local drug regulatory departments will unify the licensing review, registration, licensing and regulatory standards under the new pharmaceutical industry, new business form, new technology and new mode, jointly study the credit rating evaluation system, jointly issue the supervision and inspection rules for mutual inspection and mutual evaluation, build a team of license reviewers and inspectors, strengthen the post event supervision and cross regional supervision Joint law enforcement inspection, and close cooperation in the implementation of the drug listing permit holder system and the medical device registrant system. In terms of strengthening the construction of inspectors' team, we will take advantage of the advantages of enterprises in Beijing, Tianjin and Hebei, establish training bases for medical device supervisors, technical evaluation and training practice bases for medical devices, innovate training methods, and improve the professional ability of inspectors' reviewers through on-the-spot training, observation and learning, hands-on practice, discussion and exchange, etc., and strengthen the post event and in event training Supervision. In the aspect of information sharing, we will improve the mechanism of information sharing and risk exchange, report the risk management information of drugs, medical devices and cosmetics inspection and monitoring, adverse reactions or adverse events regularly in three places, and realize regional regulatory information and data sharing. In the aspect of case investigation and handling linkage mechanism, Beijing, Tianjin and Hebei will establish an emergency response and collaborative response mechanism for drugs, medical devices and cosmetics emergencies. Through the establishment of three coordinated investigation teams, they will cooperate and support each other in case clues, investigation and evidence collection, inspection and supervision, and severely punish cross regional illegal and criminal acts. The reporter learned from Beijing Municipal Drug Administration that in the future, the three places will further optimize the business environment, complement each other's advantages, lead the adjustment of the pharmaceutical industry structure and technological innovation, promote the integrated and coordinated development of Beijing Tianjin Hebei drug, medical equipment and cosmetics supervision at a higher level, a deeper level and a wider field, and jointly build a barrier for public safe drug use.