CFDA will carry out special major inspection to affect traditional Chinese medicine enterprises

[policies and regulations of China Pharmaceutical network] the general office of the food and Drug Administration recently issued the notice of the general office of the food and Drug Administration on carrying out the special inspection of Chinese herbal extracts In order to further implement the requirements of extract management and strengthen the supervision of Chinese herbal extracts, the general Office of the food and Drug Administration decided to carry out the special inspection of Chinese herbal extracts (CFDA will carry out a special major inspection to affect traditional Chinese medicine enterprises photo source: Baidu photo) ▍ potential safety hazards of traditional Chinese medicine extraction According to the recent flight inspection of the General Administration, there are still some enterprises that produce and purchase traditional Chinese medicine extracts in violation of regulations, which brings potential safety hazards to the quality of traditional Chinese medicine   Earlier, the relevant directors of the competent department of the General Administration pointed out in public that there were some outstanding problems in the supervision of the extraction of traditional Chinese medicine and the extraction of traditional Chinese medicine, which were mainly manifested as follows: first, some proprietary Chinese medicine enterprises did not have the ability to extract, and it was difficult to guarantee the quality of drugs produced by purchasing illegal extracts; second, the relevant management system was not perfect, which was in the division of corporate responsibility, regulatory responsibility and qualitative analysis There are still loopholes in punishment; third, the existing drug regulatory laws and regulations do not clearly define the regulatory attributes of traditional Chinese medicine extracts, the production and use of traditional Chinese medicine extracts are not clear, and they are free from the whole process of drug quality supervision system From the perspective of the industry, on the one hand, due to the limitations of extraction equipment and technology, or limited production capacity, the extraction of traditional Chinese medicine by some proprietary Chinese medicine manufacturers depends on entrusted processing; on the other hand, some professional traditional Chinese medicine extraction manufacturers do not have varieties of proprietary Chinese Medicine, so they specialize in extraction In the industry, the phenomenon of self built workshop extracting and purchasing extract feeding coexists, and a few enterprises neglect the quality responsibility requirements such as quality standards, quality monitoring, technical guidance, etc in the entrusted processing ▍ ginkgo leaf event: extraction of traditional Chinese medicine is a key link in the production of traditional Chinese medicine, and the problem of extraction of traditional Chinese medicine has always been an old problem faced by the traditional Chinese medicine industry As early as 2014 and 2015, the General Administration issued announcements successively to standardize the management of traditional Chinese medicine extraction and extract and ensure the quality of traditional Chinese medicine In May 2015, "ginkgo leaf incident", in order to reduce 4000 yuan per ton, Guilin Xingda pharmaceutical changed the production process of ginkgo leaf extraction without authorization, affecting many pharmaceutical enterprises, causing industry shock Guilin Xingda Pharmaceutical Co., Ltd and WAN Bangde (Hunan) Natural Medicine Co., Ltd illegally produced extracts and sold products to other enterprises, including 24 enterprises including Yunnan Baiyao, Qianyuan pharmaceutical and Fangsheng pharmaceutical were involved in the incident The General Administration attaches great importance to the special treatment of Ginkgo biloba drugs At the same time, it stipulates that, since January 1, 2016, the production of traditional Chinese medicine can no longer be entrusted for extraction Any Chinese patent medicine manufacturer that does not have the ability to extract traditional Chinese medicine will stop the production of corresponding varieties, and the purchased extracts must be in accordance with the law ▍ specific contents of the notice: relevant work notices are as follows: 1 Inspection contents (1) key inspection of traditional Chinese medicine extract production enterprises: production record of extract; production organization in accordance with GMP requirements; whether there is OEM production of purchased traditional Chinese medicine extract (II) key inspection of traditional Chinese medicine manufacturers: the use and filing of extracts; the quality evaluation and supplier audit of extracts; whether the material balance is in the production process; whether there is any illegal use of extracts (3) the key inspection of the pharmaceutical manufacturers that share and set up extraction workshops in different places within the group: the examination and approval of the provincial food and drug administration; the production and quality management of the extracts; and the adequacy of the quality control measures in the storage, packaging, transportation and other aspects of the extracts (4) the implementation of the filing of traditional Chinese medicine extracts by the provincial food and Drug Administration: the overall situation of the filing of extracts; whether the enterprises and varieties that have been filed meet the requirements of Document No 135, and whether the filing that does not meet the requirements has been handled; the daily supervision and extended inspection of the enterprises and varieties that have been filed II Work arrangement (I) from the inspection and rectification stage (from the date of issuance to the end of August 2017) Each provincial food and drug administration shall notify the relevant enterprises producing and using Chinese herbal extracts in the administrative region to carry out self inspection as soon as possible, conduct comprehensive and in-depth investigation against the inspection contents, timely rectify and record the problems found, complete the self inspection report, and report the self inspection to the local provincial food and drug administration before August 30, 2017 (II) inspection stage of provincial food and Drug Administration (September 2017) Each provincial food and drug administration shall formulate a detailed inspection plan according to the inspection focus, organize special inspection, investigate and deal with the problems found in accordance with laws and regulations, urge enterprises to produce and use extracts in strict accordance with the requirements of Document No 135, and implement the main responsibility of enterprises (III) analysis and summary stage (October 2017) Summarize the special inspection work, including the work of record management and supervision and inspection, main results, existing problems, rectification implementation, daily supervision requirements and relevant suggestions Please submit the summary of special inspection to the Department of pharmaceutical and chemical supervision of the State Administration before November 15, 2017 3 Work requirements (1) raise awareness and strengthen leadership Local food and drug supervision and administration departments at all levels should fully understand the importance of continuously strengthening the supervision and administration of Chinese herbal extracts, further strengthen the supervision of the production and use of extracts, and resolutely maintain the order of production and operation of Chinese herbal medicines It is necessary to strengthen the organization and leadership of this work, combine with the local reality, refine the work tasks, innovate the work methods, strengthen the supervision and inspection, clarify the daily supervision tasks of extract production and use, and implement the local supervision responsibility (2) to highlight key points and investigate and deal with them seriously Local food and drug supervision and administration departments at all levels should focus on the supervision and inspection according to the key points of this supervision and inspection For the problems found in the supervision and inspection, relevant enterprises must be required to rectify within a time limit and actively urge the rectification to be in place; for the illegal problems found in the inspection, they must be firmly investigated and dealt with in accordance with the law, and the illegal behaviors should always be kept in a high-pressure situation (3) to strengthen the joint inspection and improve the mechanism We need to further strengthen the assistance of case investigation and improve the relevant working mechanism In the process of supervision and inspection, if it is found that the illegal production and use of traditional Chinese medicine extract involves production and business enterprises outside the administrative region, it shall be reported to the relevant food and drug supervision and administration department for joint inspection in a timely manner, and the food and drug supervision and administration department receiving the joint inspection requirements shall seriously organize the joint inspection work and feed back the joint inspection results in a timely manner If the assistance is not timely and in place, the information can be fed back to the general administration The General Administration will continue to carry out flight inspection on enterprises producing and using Chinese herbal extracts Praise those who have made great efforts to promote the special inspection work and have good remediation effect, and criticize those who have repeatedly encountered problems, failed to rectify in place and failed to fulfill their responsibilities For regions where problems are concentrated, the General Administration will interview local government departments to urge rectification in place.