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[Pharmaceutical Network Industry News] In recent years, under the background of accelerating the reform and upgrading of the pharmaceutical system and the fact that production site inspections have become the new normal of drug supervision, supervision and random inspections of pharmaceutical companies by the country and even all over the country are becoming more and more frequent
.
Since the beginning of this year, the State Food and Drug Administration has issued several announcements, and a large number of products have also been suspended from sales, recalled and other risk control measures due to non-compliance with regulations
.
For example, on August 29, the website of the State Food and Drug Administration issued a notice on the non-compliance of 20 batches of drugs: after inspection by 6 drug testing institutions including China National Institute for Food and Drug Control, it was marked as 9 companies including Zhengzhou Ruilong Pharmaceutical Co.
, Ltd.
20 batches of medicines such as comfrey, chrysanthemum and Huoxiangzhengqi water produced by the company did not meet the regulations
.
These drugs do not meet the specified items, including character, identification, total ash, acid-insoluble ash, and leachables
.
For the above-mentioned drugs that do not meet the regulations, the drug supervision and administration department has required relevant enterprises and units to take risk control measures such as suspension of sales and use, recall, etc.
, to investigate the reasons for non-compliance and make effective rectifications
.
On July 14, the website of the State Food and Drug Administration issued a notice on 19 batches of drugs that did not meet the regulations
.
After inspection by 10 drug inspection institutions including Hubei Provincial Institute of Drug Supervision and Inspection, 19 batches of drugs, including acetylcysteine injection, which were labeled as acetylcysteine injection produced by 16 companies including Ruiyang Pharmaceutical Co.
, Ltd.
, did not meet the requirements
.
On June 20, the State Food and Drug Administration issued an announcement stating that after inspection by 8 food and drug quality inspection institutes in Fujian Province and Heilongjiang Province, it was labeled as Xiaoergan Granules produced by 9 companies including Guangxi Golden Throat Pharmaceutical Co.
, Ltd.
10 The batch of drug product did not meet the regulations
.
It is worth noting that, in addition to pharmaceutical companies, with the continuous development of the economic level, the demand for health is increasing day by day.
While China's medical device market will usher in huge development opportunities, the domestic supervision of the medical device industry is also constantly tightening.
.
Since the beginning of this year, relevant domestic departments have also conducted random inspections of medical device companies
.
On August 4, the Gansu Provincial Drug Administration issued the "Announcement on the Disposal of Products and Enterprises That Do Not Conform to the Regulations in Medical Sampling"
.
The announcement shows that the bureau has organized 23 varieties of products including medical surgical masks, disposable medical masks, medical infrared forehead thermometers, medical protective masks, disposable rubber examination gloves, and medical disposable protective clothing throughout the province.
797 batches of quality supervision and sampling were carried out, of which 36 batches of products did not meet the standard requirements, and the "Medical Device Quality Announcement of Gansu Provincial Drug Administration" (2021 No.
36, No.
52), (2022 No.
18)
.
In April, the State Food and Drug Administration issued a notice on the results of national medical device supervision and sampling inspections, showing that the State Food and Drug Administration recently organized product quality supervision and sampling inspections on 5 varieties including intervertebral fusion devices and semiconductor laser treatment machines, with a total of 12 batches.
(Taiwan) The product does not meet the standard requirements
.
In the same month, the Fujian Provincial Food and Drug Administration also conducted a round of supervision and sampling of medical devices.
The inspection found 6 batches of products that did not meet the standards, including medical surgical masks, medical disposable protective clothing, etc.
The unqualified items included microbial indicators, mask belts, etc.
etc.
are not in compliance with the regulations
.
.
.
.
.
.
.
Industry analysts believe that frequent random inspections mean that the safety of drugs and medical devices has become the focus of attention in the industry
.
In this context, the only way for pharmaceutical companies to survive is to regulate their operations, adjust their production and management strategies in a timely manner, and continuously improve product quality
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
Since the beginning of this year, the State Food and Drug Administration has issued several announcements, and a large number of products have also been suspended from sales, recalled and other risk control measures due to non-compliance with regulations
.
For example, on August 29, the website of the State Food and Drug Administration issued a notice on the non-compliance of 20 batches of drugs: after inspection by 6 drug testing institutions including China National Institute for Food and Drug Control, it was marked as 9 companies including Zhengzhou Ruilong Pharmaceutical Co.
, Ltd.
20 batches of medicines such as comfrey, chrysanthemum and Huoxiangzhengqi water produced by the company did not meet the regulations
.
These drugs do not meet the specified items, including character, identification, total ash, acid-insoluble ash, and leachables
.
For the above-mentioned drugs that do not meet the regulations, the drug supervision and administration department has required relevant enterprises and units to take risk control measures such as suspension of sales and use, recall, etc.
, to investigate the reasons for non-compliance and make effective rectifications
.
On July 14, the website of the State Food and Drug Administration issued a notice on 19 batches of drugs that did not meet the regulations
.
After inspection by 10 drug inspection institutions including Hubei Provincial Institute of Drug Supervision and Inspection, 19 batches of drugs, including acetylcysteine injection, which were labeled as acetylcysteine injection produced by 16 companies including Ruiyang Pharmaceutical Co.
, Ltd.
, did not meet the requirements
.
On June 20, the State Food and Drug Administration issued an announcement stating that after inspection by 8 food and drug quality inspection institutes in Fujian Province and Heilongjiang Province, it was labeled as Xiaoergan Granules produced by 9 companies including Guangxi Golden Throat Pharmaceutical Co.
, Ltd.
10 The batch of drug product did not meet the regulations
.
It is worth noting that, in addition to pharmaceutical companies, with the continuous development of the economic level, the demand for health is increasing day by day.
While China's medical device market will usher in huge development opportunities, the domestic supervision of the medical device industry is also constantly tightening.
.
Since the beginning of this year, relevant domestic departments have also conducted random inspections of medical device companies
.
On August 4, the Gansu Provincial Drug Administration issued the "Announcement on the Disposal of Products and Enterprises That Do Not Conform to the Regulations in Medical Sampling"
.
The announcement shows that the bureau has organized 23 varieties of products including medical surgical masks, disposable medical masks, medical infrared forehead thermometers, medical protective masks, disposable rubber examination gloves, and medical disposable protective clothing throughout the province.
797 batches of quality supervision and sampling were carried out, of which 36 batches of products did not meet the standard requirements, and the "Medical Device Quality Announcement of Gansu Provincial Drug Administration" (2021 No.
36, No.
52), (2022 No.
18)
.
In April, the State Food and Drug Administration issued a notice on the results of national medical device supervision and sampling inspections, showing that the State Food and Drug Administration recently organized product quality supervision and sampling inspections on 5 varieties including intervertebral fusion devices and semiconductor laser treatment machines, with a total of 12 batches.
(Taiwan) The product does not meet the standard requirements
.
In the same month, the Fujian Provincial Food and Drug Administration also conducted a round of supervision and sampling of medical devices.
The inspection found 6 batches of products that did not meet the standards, including medical surgical masks, medical disposable protective clothing, etc.
The unqualified items included microbial indicators, mask belts, etc.
etc.
are not in compliance with the regulations
.
.
.
.
.
.
.
Industry analysts believe that frequent random inspections mean that the safety of drugs and medical devices has become the focus of attention in the industry
.
In this context, the only way for pharmaceutical companies to survive is to regulate their operations, adjust their production and management strategies in a timely manner, and continuously improve product quality
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
