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published in(发表于) 2014/8/21 9:03:45
People’s Congress report and also to question the food and drug administration

　　Since 2007, several batches of rabies vaccine lot release crude drug industry rejected records

Beijing News newsletter (reporter Liu Suhong) real-name translation of Henan provincial people's Congress and the food and Drug Administration reported the latest progress. 19th evening, translated Tweet again, raised a question on response to the food and drug administration.

On August 18, the gruffs, Chairman of Henan provincial people's Congress, Liaoning, Henan, according to the translation of pharmacognosy, Chairman of industry reporting of relevant officials of the food and drug administration, describing them as "dereliction of duty, abuse of authority, suspected of malfeasance," "400 million loss caused by vaccine lot release".

The next day, translated by the food and drug administration through its Web site in response to real-name reporting, saying checks found in Liaoning was born in sterility assurance of key link and there is a serious problem, posed a serious risk to vaccinees. The company's 120 approved rabies vaccine for censorship, 3 batches of vaccines is found not qualified, the remaining 117 batches of rabies vaccine after the submission did not receive a qualified approval and issuance.

Industry insiders to a Beijing News reporter, 120 shipments of vaccine available for use by more than 3.6 million people, "once getting into the market, the health of more than 3.6 million people will be affected, output value of 400 million, compared with 3.6 million people health, pros, at a glance."

Night, Zhang translated again on food drug general reply proposed three big question, specific for: Liaoning according to born approval of 117 batch vaccine no bacteria test by Jilin province drug tests by test all is qualified of, food drug General not for batch issued program is illegal of; 9 months in the does not on remaining 117 batch products law made decided; on food drug General and in the seized homes risk assessment of according to for question.

But translated, none of the food and Drug Administration noted that the enterprise "sterility assurance of key link and there is a serious problem," the core issue, and direct response.

　　Ask

　　1. sterility assurance of vaccine link if there is a problem?

According to the Beijing News reporter, after someone reports translation company in the production of lyophilized rabies vaccine for human use in the process of illegal sterilization filtration, creating a semblance of inspection. Also said that the business operation violations, to meet some standards.

In this regard, on August 20, translated to Beijing News reporter responded that such evidence needs to come up with more concrete evidence to the State food and drug administration after the verification shall prevail.

　　2. vaccine production process have a contamination record?

Also, it has been said that translation of the enterprise using the relative backwardness of the roller bottle process, each batch of vaccine contamination exists, up to a maximum rate of 30% per cent of the pollution, however, the company never had a similar record. Some question whether the company from top to bottom to form a false chain.

It is understood that since 2007, the company existed several batches of rabies vaccine lot release their bad track record. According to incomplete statistics, in 2007, China's food and drug inspection Institute (found in the hereinafter hospital) 7 batches of rabies vaccines made by the company without notice, and the 26 violations early in the production of vaccines will not be issued in 2008, the company has 8 batches of vaccine are not eligible from 2009 to 2011, the company's substandard vaccines every year. In 2013, the company 3 batches of vaccine contamination several re-inspection still unqualified, that "there are very serious pollution, the enterprise produces sterile control in very poor", insiders revealed to the Beijing News.

In this regard, the translation of Beijing News reporter explained that he was responsible for the company's operations, not the front line. The company "several batches of rabies vaccines are not qualified" one thing, he said, "companies were reporting more often, but in the end is no such, or is that sentence, whether the food and Drug Administration investigated and dealt with issues to prevail."

　　3. food and drug administration "shall not be issued a" notice of compliance?

Translated earlier network report also suggested that, in accordance with the Biologics lot release management stipulates that seized homes should be finished in 55 days, approval and issuance work. "117 batches of vaccine are either qualified or unqualified, not approval and issuance practices do not meet requirements. "Translated over the phone to Beijing News Reporter explains.

And food drug General is in 19th of responded in the said, according to bio batch issued management approach, food drug regulatory General on Liaoning according to born company site assault check, found enterprise production does exists problem Hou, in the seized homes specifically held expert will, in the seized homes according to test results, and site check situation and expert argument views, on and 3 batch no bacteria test not qualified vaccine in same production cycle of 117 batch vaccine, made has not batch issued of decided, and to Liaoning according to born company issued has written notification.

　　4. Liaoning companies suspected of bribery?

According to media reports, September 2014, Jiang ' an County Center for disease control Director Yang taking Yibin area Liaoning bio-pharmaceutical company sales representative Guo XX rabies vaccine rebate was convicted of bribery.

Inform the Commission the night of August 2, Counselor of Shenyang, Shenyang city, Liaoning province food and drug administration, former Director General Wang Yanling for suspected serious disciplinary offences against the law, currently under investigation. Complaint over allegations that he is close with translation.

Translate on the Beijing news reporters, he did know Wang Yanling, but it needed more factual evidence of such reports. "If I were a bribery, firms don't so much".

Finally, translated by telephone also said, "tomorrow I will reflect the food and Drug Administration inspected a number of nonconforming product to market conditions".

The Beijing News new media reporter Liu Suhong

(Original title: "the deputies reported food and drug administration" continues a contentious question)

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