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| Anhui province further strengthens the extraction of traditional Chinese medicine and the production of Chinese medicine |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-4 10:13:10 Number Browse：715 |
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On August 4th, the pharmaceutical network of anhui traditional Chinese medicine production enterprises will face a major storm.
On August 3, anhui food drug administration issued "about further strengthen the regulation of traditional Chinese medicine extraction and proprietary Chinese medicine production notice (anhui food drug safety medicine im the secret [2017] no. 351), announced to a full Chinese medicine production enterprises within their respective jurisdictions.
Check include: check the consistency of the actual production process and register to declare whether there is any violation of administration on the strengthen supervision and management in the production of traditional Chinese medicine extraction and extract notice (food medicine drug safety supervisor [2014] no. 135) and 2015 announcement no. 286 is required.
The problem of extraction of traditional Chinese medicine has always been the old problem faced by the traditional Chinese medicine industry.
In July 2014, the state administration of food drug safety was issued on strengthen supervision and management in the production of traditional Chinese medicine extraction and extract notice (food medicine drug safety supervisor [2014] no. 135), a clear extracts from traditional Chinese medicine extraction and management requirements.
The notice clearly states that "extraction and extraction of traditional Chinese medicine is the precondition and material basis to ensure the quality control and safety of Chinese medicine. In recent years, with the scale and intensive development of traditional Chinese medicine production, the problems of extraction of traditional Chinese medicine or the extraction of traditional Chinese medicine are prominent, which poses a hidden danger to the quality and safety of traditional Chinese medicine.
The file also make clear a regulation, Chinese traditional medicine production enterprises and traditional Chinese medicine extract production enterprises shall satisfy with the products that meet the needs of Chinese herbal medicine treatment facilities, equipment, make corresponding pretreatment process procedures, processing of Chinese medicinal materials and processing. In order to produce Chinese traditional Chinese medicine, it must be purchased from the production and operation enterprises of traditional Chinese medicine with legal qualification.
Anhui has always been a big province of traditional Chinese medicine, involving many enterprises, and all varieties will be included in the inspection and tracking range.
In accordance with the "notice" published yesterday, "according to the specific varieties of different enterprises, to develop personalized checks, one by one varieties all follow-up production, strengthen the traditional Chinese medicine extraction and the regulation of the proprietary Chinese medicine production, through the yearly check, strive for the area under its jurisdiction enterprise varieties in traditional Chinese medicines to check the full coverage, truly establish the long-term effective mechanism of supervision."
Attached: anhui food and drug administration for further strengthening the Chinese medicine extraction and the administration of the production supervision of Chinese medicine
(anhui food and drug administration (2017) no. 351)
Food and drug administration of the municipal and direct administrative counties:
According to the general office of administration of the drug regulatory focus on work arrangement about print and distribute 2017 notice (food do medicine drug safety supervisor [2017] 38) requirements, combining the reality of Chinese native medicine preparation in our province supervision, are currently the following notice:
First, to make the extraction of traditional Chinese medicine and the supervision of the production of TCM
The municipal and direct management bureau should conduct a thorough review of the traditional Chinese medicine production enterprises on the basis of daily supervision.
Check the consistency of the actual production process and register to declare whether there is any violation of administration on strengthen supervision and management in the production of traditional Chinese medicine extraction and extract notice (food medicine drug safety supervisor [2014] no. 135) and 2015 announcement no. 286 is required.
It is necessary to check whether the process and methods of extraction process and methods are changed without authorization. Whether the production process of the preparation is carried out according to the production process of the registered declaration, whether it is illegal to add traditional Chinese medicine raw powder; Whether the production equipment or process changes are verified, whether the relevant procedures are completed in time; Whether the use of the extract is in conformity with the provisions, whether it has been filed.
Ii. Urge enterprises to perform the duties of the first responsible person for drug quality
Municipalities, straight pipe county bureau in supervision work, to further a line, understand the real situation of enterprise production, and the administration of the recent announcement of traditional Chinese medicine production enterprises violation cases on-site interpretation, make the enterprise to improve yourself as the consciousness of the person in charge of pharmaceutical production quality is the first clear violation cost, do strict according to the drug production quality management standard organization production.
Third, establish the Chinese medicine extraction and the production supervision of the production supervision mechanism
Municipalities, straight pipe county bureau to combining the reality of regulation, the varieties of different enterprises, to develop personalized checks, one by one varieties for production all tracking all the way, strengthen the traditional Chinese medicine extraction and the regulation of the proprietary Chinese medicine production, through the yearly check, strive for the area under its jurisdiction enterprise varieties in traditional Chinese medicines to check the full coverage, truly establish the long-term effective mechanism of supervision.
The research on the extraction of traditional Chinese medicine and the potential common problems in the production of Chinese medicine is to be studied in various cities and direct management counties, and summarized and summarized the administration of pharmaceutical cosmetics production in the provincial bureau. The provincial bureau will organize the inspectors in time and extract a certain proportion of the traditional Chinese medicine production enterprises for on-site inspection and extension inspection. The violation of laws and regulations found in the inspection shall be publicly announced and investigated seriously.
Anhui food and drug administration
August 1, 2017 |
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