A big news suddenly broke the tranquility of the night.
Headlines after headlines were popping up on everyone’s phones, all saying the same thing.
“The State Food and Drug Administration requires a strict investigation into the cancer-causing issue of Sanofi’s antihypertensive drugs.”
“Sanofi’s irbesartan drug was found to contain nitrosamines and was ordered to recall the problematic drug.”
“The Food and Drug Administration strikes with an iron fist, forcing the recall of problematic drugs or imposing large fines.”
Netizens were stunned when they saw these news.
In the past few days, they have been scolding those foreign companies with double standards on the Internet.
Unexpectedly, the Food and Drug Administration would take action in such a short period of time and forcefully deal with the issue of double labels for problematic drugs.
Suddenly I felt refreshed and elated.
When I opened the hot search, I saw that even the official CCTV news account issued a stern announcement.
“In response to the detection of nitrosamines in irbesartan tablets, a drug sold globally by the Gallic state-owned pharmaceutical company Sanofi, the State Food and Drug Administration attached great importance to it and immediately launched an investigation into the Chinese branch of Sanofi and dealt with it in accordance with the law. "
"The Beijing Food and Drug Administration immediately organized personnel to conduct random inspections of the drugs sold by Sanofi. After preliminary investigation and analysis, nitrosamine substances were detected in the antihypertensive drug Ambowi sold by Sanofi. This is due to the company's production process. Caused by process problems."
"The State Food and Drug Administration has dealt with this serious safety incident and required Sanofi's China branch to immediately recall the batch of drugs in question and handle related compensation and personnel litigation in accordance with the law."
“After all the drugs are recalled, an additional administrative fine of twenty times will be imposed based on the amount involved.”
"Any pharmaceutical manufacturer in China must put product quality first and consciously abide by my country's laws, regulations and relevant technical specifications."
"Whenever product defects or quality problems occur, recall measures must be taken, reports must be made to the drug regulatory authorities, and information must be proactively disclosed to the public. All drugs recalled abroad must be recalled simultaneously in China."
"The Food and Drug Administration will further intensify supervision and grasp recall information from drug regulatory agencies in various countries in a timely manner. If drug manufacturers fail to report recalls or recall in a timely manner, strict regulatory measures will be taken until the production and sale of drugs in China is stopped."
Netizens were all shocked when they saw this handling notice.
This is the first time that the State Food and Drug Administration has made a strong public statement to pharmaceutical companies in China.
People can see from this the official determination to strictly regulate drug safety.
Between the lines, there is a murderous aura.
Netizens were silent for a long time, and after a while, they suddenly cheered.
"The General Administration is wise and well done!"
"Refund the problematic drugs! Refund! Refund!"
"I called you a double standard. If you talk hard and don't recall it, you must be suppressed by the iron fist now, hahaha!"
"Punish! Punish them severely! Don't be polite, you must punish them until they feel physical pain!"
"Are there any problems with other antihypertensive drugs? We need to check this out."
"In the future, you should take Sanqing as your antihypertensive medication. Don't worry about taking it."
"Support! We must strictly investigate and deal with it in accordance with the law!"
"I just went to the official website of the Food and Drug Administration. In the past year, there have been quite a few recalls of problematic drugs. Most of them were domestic pharmaceutical companies. This time it is finally the turn of foreign companies."
"Since the last Changsheng vaccine accident, the pharmaceutical industry still attaches great importance to drug safety issues. No, the official responded immediately."
"I hope other industries can follow suit and deal with these double-standard foreign companies. I remember the last double-standard incident of Menglong ice cream, but there seems to be no further details."
"Then you have to go to the State Administration for Market Regulation. Maybe the double-standard ice cream issue is not serious. After all, it's just a falsification of the ingredient list. It's not killing people. It must be more serious because there are no drugs that cause cancer."
"Hey, I am completely reassured about drug safety now. When will we be able to take a heavy blow on food safety issues so that everyone can eat with more confidence?"
"It's hard to say that in this domestic market environment, if there are no problems, we will not learn lessons."
"If something goes wrong, we won't learn lessons. The pickled vegetables with foot skin are still being sold. We can only vote with our feet. Just don't buy it."
"That's right, whether it's medicine or food, we must buy conscientious domestic products in the future. We must make double-standard foreign companies either completely cool or on the road to coolness."
At the same time, Sanofi officially apologized to the entire network and announced a recall of the problematic batch of antihypertensive drugs.
"I'm sorry for betraying everyone's trust. We sincerely apologize to all the Chinese people for the mistakes we made."
"We will officially recall all problematic drugs sold in the Chinese market. After inspection, the problematic batches are xxxx and xxxx. Patients who bought these batches of drugs are asked to return them to the original hospital immediately, and the payment will be refunded. "
"From now on, we will be responsible for public health, carefully find the cause of the problem, improve quality management, implement various risk control measures, eliminate safety hazards, and ensure the quality of products on the market."
"If you have any questions, please do not hesitate to contact us as soon as possible to discuss follow-up methods. Thank you!"
This time, Sanofi did not dare to close the comments anymore. Netizens flocked in to vent their emotions.
"You are told to be tough, but no matter how tough you are, can it still be tougher than the people's iron fist?"
"I hope the officials will be so tough in the future and suppress double-standard foreign companies."
"This time, I am with the Food and Drug Administration, @Market Supervision Bureau, take a good look at what they are doing!"
"Learn from me, @Pfizer, @Johnson & Johnson, @MERSD, @Roche, @MAPLEGOose, @Nike, @二星, @ Toyota, @Volkswagen, @IKEA, @梦龙."
Under this announcement, netizens labeled all double-standard foreign companies @.
I also keep going to their official homepage to write comments.
For a time, all the foreign companies looked at this formation, and they were all frightened and trembling.
While they were glad that they were not the ones being sacrificed, they wailed inwardly.
Is the Chinese market about to change?
Are the officials trying to scare the monkeys?
Will we have to be strictly investigated if problems arise in the future?
At the thought of this, all the senior executives in the Huaxia District of foreign companies felt a chill on their necks and a cold wind blowing through them.
****
After Sanofi was established as a model, the Food and Drug Administration of various cities began to increase their efforts to randomly inspect drugs on sale and detect drug quality problems.
Other pharmaceutical companies have also responded and strengthened the quality control of their own drugs.
Suddenly, there was a turmoil, and the number of imported drugs in the entire antihypertensive drug market dropped sharply.
Under such circumstances, the antihypertensive drugs launched by Sanxin were almost driven in by a strong force, filling the market that suddenly fell into a vacuum in an instant.
The Food and Drug Administration also wanted to understand the matter of Sanofi's approval.
It would be difficult for pharmaceutical companies to voluntarily declare problems and initiate recalls. However, like Yingguo, they must strengthen supervision and impose strict penalties to really make a difference.
Generally speaking, after an adverse reaction occurs to a drug, companies should conduct a safety evaluation and choose to add a black box to warn of risks, or restrict the use of the drug by the population. If the risk of the drug outweighs the benefits, it needs to be recalled.
Recalls must also distinguish between different situations. If there is a problem with the drug formula or medical device, or the product itself is defective, then all products must be recalled.
And if there is a non-systemic quality problem in a certain production link or transportation link, then only the batch of products needs to be recalled.
Due to the wide variety of drug categories, it is impossible for regulatory authorities to fully grasp the adverse reactions of all drugs at the first time. They mainly rely on proactive reporting by companies.
Adverse drug reaction monitoring is the upstream link of drug recalls, and logically it should play a major role.
Drug recalls are the last firewall for drug safety.
In Eagle Country, 60% of adverse drug reaction reports are reported by companies on their own initiative, but in China, the opposite is true.
The proportion of adverse drug reaction testing reports by domestic pharmaceutical companies is only 25%.
If adverse drug reaction information is not reported in time, subsequent drug recalls will inevitably be missing.
To ensure drug safety, not only does supervision need to be strengthened, but companies themselves must also be able to correctly handle the relationship between corporate interests and patient interests.
After this incident, drug safety issues once again attracted the attention of decision-makers.
This time the Food and Drug Administration’s thunderous move undoubtedly revealed their attitude and determination.
