More strict supervision on the extraction of traditional Chinese medicine and the production of Chinese patent medicine in Anhui Province

[China Pharmaceutical network industry trends] in recent years, with the rapid development of traditional Chinese medicine industry, the state's supervision of traditional Chinese medicine production has become increasingly strict On August 3, Anhui Provincial Food and Drug Administration issued a notice on Further Strengthening the supervision of the extraction of traditional Chinese medicine and the production of proprietary Chinese medicine (picture source: Baidu picture) in accordance with the requirements of the notice on printing and distributing the key work arrangement of drug supervision in 2017 (sfjyhj [2017] No 38) issued by the general office of the General Administration of the State Council, and in combination with the actual work of Anhui Province, we hereby make the following notice: I do a good job in the supervision of the extraction of traditional Chinese medicine and the production of traditional Chinese medicine All cities and directly administered County bureaus should carefully sort out the production enterprises of traditional Chinese medicine within their jurisdiction on the basis of daily supervision Check the consistency between the actual production process and the registration and application process, and check whether there is any violation of the requirements of the circular on strengthening the supervision and management of extraction and extraction in the production of traditional Chinese medicine (sfjyhjj [2014] No 135) and the Announcement No 286 in 2015   It is important to check whether the pre-treatment and extraction of traditional Chinese medicine of enterprises have changed the extraction process and method without authorization; whether the production is carried out according to the registered production process in the preparation process, and whether there is any illegal addition of traditional Chinese medicine raw powder in violation of regulations; whether the changes of production equipment or process have been verified, and whether the relevant procedures have been improved in time; whether the use of extract If it meets the requirements, whether it has been filed II Urging the enterprise to fulfill the responsibilities of the person in charge of drug quality In the process of supervision, the municipal and directly administered County bureaus should go deep into the front line, understand the real situation of enterprise production, and give on-the-spot explanation to the illegal cases of traditional Chinese medicine production enterprises announced by the General Administration recently, so that the enterprises can improve their awareness as the responsible person of drug production quality, understand the cost of illegal activities, and organize production in strict accordance with the standard of drug production quality management III establish a long-term mechanism for the extraction of traditional Chinese medicine and the supervision of the production of Chinese patent medicine The municipal and directly administered County bureaus shall, in combination with the actual situation of supervision, formulate personalized inspection plans for specific varieties of different enterprises, track the whole process of production by varieties, practically strengthen the supervision of the extraction of traditional Chinese medicine and the production of Chinese patent medicine, and strive to achieve the full coverage of the inspection of the varieties of traditional Chinese medicine produced by enterprises in the jurisdiction through annual inspection, so as to truly establish a long-term supervision mechanism All cities and counties directly under their jurisdiction shall study the potential common problems found in the extraction of traditional Chinese medicine and the production of Chinese patent medicine, and summarize and report to the drug and cosmetic production supervision office of the Provincial Bureau The Provincial Bureau will timely organize inspectors to select a certain proportion of traditional Chinese medicine manufacturers for on-site inspection and extended inspection The illegal issues found in the inspection shall be announced and dealt with seriously according to law.