Shanghai's latest issue affects all medical people

Yesterday (November 15) an implementation plan for the special rectification of "blocking regulatory loopholes and improving regulatory level" by Shanghai drug regulatory bureau was posted on the official website of Shanghai Municipal People's government, hereinafter referred to as the "plan" According to the plan, Shanghai will organize and carry out the special rectification work of "blocking regulatory loopholes and improving regulatory level", clarify the division of responsibilities, refine the rectification tasks, continuously check and examine the weak links and potential risks in the supervision work, study and formulate targeted rectification measures, and further plug the loopholes in the supervision of drugs, medical devices and cosmetics in Shanghai It can be seen that the supervision of drugs in Shanghai will be further strengthened According to the spirit of No 36 document issued by the State Council and in combination with the actual situation of the city, the plan further promotes the construction of professional drug inspectors, formulates the implementation measures for promoting the construction of professional drug inspectors and relevant supporting systems, and incorporates the requirements and indicators related to the construction of professional drug inspectors into the 14th five year plan of drug supervision of the city " This work is led by the personnel department, and implemented by all departments and directly affiliated units The completion time limit is before the end of 2020 This brings us back to the topic that we are very concerned about - does the cancellation of GMP and GSP certification mean that the future supervision will be more strict? There's no doubt that's for sure Although GMP and GSP certification have been cancelled, pharmaceutical enterprises still cannot be careless in quality and should do better In the past, many people were looking forward to cancellation because most people thought the authentication process was too cumbersome However, after the certification is cancelled, will the regulatory authorities really not check it? On the contrary, it will definitely be more and more scientific On July 18, 2019, the general office of the State Council issued the opinions on the establishment of a team of professional drug inspectors, which mentioned that professional drug inspectors (including medical devices and cosmetics) refer to the personnel identified by the drug regulatory authorities, who legally confirm the compliance and conduct risk study and judgment on the places and activities where the management counterpart is engaged in drug research and development, production, etc., and they are the personnel who strengthen the drug industry It is an important supporting force for the supervision and protection of drug safety The purpose of establishing a team of drug inspectors in China is to build a professional team of drug inspectors that basically meets the requirements of drug supervision, further improve the professional team of drug inspectors with full-time inspectors as the main body and part-time inspectors as the supplement, and form a drug supervision and inspection system with clear rights and responsibilities, smooth cooperation and comprehensive coverage Despite the cancellation of GMP and GSP certification, from the current active establishment of a special team of drug inspectors in Shanghai, to a certain extent, it will increase the strength and frequency of daily inspection and flight inspection of enterprises Today, GMP, GSP is the floor, is the lowest standard, is the lowest threshold, so do not need certification GMP and GSP have also become the most basic and minimum configuration requirements of enterprises The plan mentioned that supervision and inspection of high-risk products and key products should be strengthened We will continue to conduct full coverage supervision and inspection of high-risk products such as vaccines, blood products, special drugs, injections and implantable medical devices, and urge enterprises to produce and operate legally and in compliance with regulations As for the key varieties to be inspected, the State Food and Drug Administration and many provinces have pointed out before, focusing on the following varieties: 1 Biological products, blood products, injections 2 Varieties of traditional Chinese medicine preparation and production technology that are difficult to control and have large output 3 Basic drug varieties winning the bid 4 Varieties with many or serious adverse reactions 5 Unqualified varieties in spot check 6 New approved new and generic drugs 7 Varieties with quality risk prompt issued by national drug sampling inspection Recently, the State Food and Drug Administration issued the notice on learning, publicizing and implementing the drug administration law of the people's Republic of China (gyjf [2019] No 45).