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| CFDA special inspection of Chinese medicine extract, which affects Chinese medicine enterprises! |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-8 10:52:29 Number Browse：620 |
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Medical network - August 8 August 1, the food and drug supervision bureau general office issued the food and drug supervision administration office to conduct special inspection of traditional Chinese medicine extract on notice, in order to further implement the management requirements of the extract, strengthen supervision, Chinese medicine extract administration research decided to carry out special inspection of traditional Chinese medicine extract.
▍ Chinese medicine extraction safe hidden trouble
According to the recent flight inspection by the general administration, there are still some enterprises that violate the regulations on production and purchase of Chinese herbal extracts, which pose a safety hazard to the quality of Chinese medicines.
Earlier, the relevant person in charge of administration departments have pointed out in public, Chinese medicine extract and some outstanding problems existing in the traditional Chinese medicine extract regulation, main show is: one is some proprietary Chinese medicine enterprises don't have the ability to extract and extracts from buying illegal drug production, quality is difficult to guarantee. Second, the relevant management system is not perfect, and there are loopholes in corporate responsibility, regulatory responsibility and qualitative punishment. Third, existing drug regulatory laws and regulations do not specify the regulatory properties of traditional Chinese medicine extracts. The production and use of Chinese herbal extracts are not clear, and they are free of the whole process of drug quality supervision.
In the employment situation, on the one hand, it is limited by the extraction equipment and technology, or the production capacity is limited, and the extraction of traditional Chinese medicine by some Chinese pharmaceutical manufacturers depends on the entrusted processing. On the other hand, some professional Chinese medicine extract manufacturers have no medicinal products, especially for extraction. The extraction of self-built workshops in the industry co-exists with the purchase of extracts, and the few enterprises have neglected quality standards, quality supervision, technical guidance and other quality responsibility requirements in the commissioning process.
▍ ginkgo biloba events
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 a notice to standardize the management of extracts and extracts from traditional Chinese medicine and to ensure the quality of Chinese medicine.
In May 2015, the "ginkgo leaf incident", in order to reduce the amount of RMB 4000 per ton, guilin xingda pharmaceutical company changed the extraction process of ginkgo leaf without authorization and affected many pharmaceutical companies, causing the industry to vibrate.
Guilin xingda pharmaceutical, bond (hunan) natural drug companies illegal production, and to sell the products to other companies, including yunnan baiyao, thousand source Fang Cheng pharmaceutical pharmaceutical, oil and other 24 companies were involved in the incident.
Administration attaches great importance to the special projects, ginkgo biloba drugs prescribed at the same time, since January 1, 2016, Chinese medicine extract production shall not entrust, whoever does not have the ability to Chinese traditional medicine extraction of proprietary Chinese medicine production enterprises, the corresponding varieties shall stop production, outsourcing extract must be in accordance with the rules in accordance with the law.
▍ notify specific content
Related work notices are as follows:
1. Check the contents
(1) key inspection of Chinese medicine extract production enterprises: the production and filing of extracts of extracts; Organize production according to drug GMP; Whether there is an outsourcing of Chinese herbal extracts for the production of branded products.
(2) key inspection of traditional Chinese medicine production enterprises: the use of extracts for the use of the record; Quality assessment of extracts and supplier audits; Material balance in the production process; The existence of illegal extracts.
(3) key examination of drug production enterprises in the group of the group within the group to set up the extraction workshop in different places: the approval of the provincial food and drug administration; Extract production and quality management; The quality control measures for the storage, packaging and transportation of extracts are adequate.
(iv) implementation of Chinese herbal extracts of the provincial food and drug administration bureau: the overall situation of the implementation of the extract filing; Whether the registered enterprises and varieties conform to the requirements of document 135, whether they are not in accordance with the requirements and whether they have been processed; The daily supervision and extension inspection of the registered enterprises and varieties.
Ii. Work arrangement
(1) self-inspection and rectification stage (from the date of Posting to the end of August 2017). Provincial food and drug supervision bureau to inform related Chinese medicine extract in the administrative areas as soon as the production and use of enterprise to carry out the check list, contrast examination content on thorough screening, to find problem timely rectification and recorded, complete inspection report, in August 2017 to 30 introspects the situation of the local provincial food and drug supervision bureau.
(2) inspection phase of provincial food and drug administration (September 2017). Provincial food and drug supervision bureau according to inspection on the detailed inspection plan, organize special inspection, to investigate discovered problems in accordance with the rules in accordance with the law, urge the enterprises no. 135 document in strict accordance with the requirements of the production and use extract, implement enterprise's main body responsibility.
(iii) analysis and summary stage (October 2017). To summarize the work of special inspection, including the work situation of filing management and supervision and inspection, main effect, existing problems, rectification and implementation, daily supervision requirements and related Suggestions. Please submit the special inspection summary to the administration of drug administration of the general administration before November 15, 2017.
Iii. Work requirements
(1) raise awareness and strengthen leadership. Local food and drug supervision and administration departments at all levels must fully recognize continue to strengthen the supervision and administration of Chinese medicine extract significance, further strengthen the regulation of extract production and use of the link, firmly maintaining the order of traditional Chinese medicine production and business operation. To strengthen organization and leadership of the work, combined with the local reality, detailed work tasks, innovative working methods, strengthening the supervision and inspection, clear extract production use daily supervision, implementation of the regulatory responsibility of possession.
(2) highlight key points and take serious investigation. Local food and drug administration departments at all levels shall, in accordance with the focus of this supervision and inspection, focus on the supervision and inspection. For the problems found in supervision and inspection, the relevant enterprises must be required to rectify the problem within a time limit and urge the rectification to be in place. We should resolutely investigate and punish violations found in the inspection, and maintain high pressure on illegal activities.
Third, strengthen the cooperation and improve the mechanism. We should further strengthen the case study and improve the relevant working mechanism. Found in the supervision and inspection, illegal production use involves the administrative region of the production and management enterprises outside of traditional Chinese medicine extract, notice food and drug supervision and administration department for investigation, from investigation for the food and drug supervision and administration department shall carefully organize to do a good job of investigation, feedback the investigation results. If the agreement is not in time, it can provide feedback to the general administration.
The general administration will continue to carry out flight inspections on the production and use of Chinese herbal extracts. In the case of the special inspection, the promotion of the work force, the improvement of the effectiveness of the praise, to the problems repeated, the rectification of the inadequate, the responsibility not to carry out the criticism. In the region of the problem, the general administration will discuss local government departments and urge rectification.
All the problems and Suggestions encountered in the special work should be promptly contacted with the administration of drug administration.
Contact: li linke, ye ka-fai
Contact number: 010-88330872, 88330812
Fax: 010-88330871
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