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Popular:ST is long live. Luo Niushan Deep Tianma A
Financial commentary
Published on 2018-07-25 23:58:32 Share it web version
                        The State Food and Drug Administration answered the problem vaccine flow and control situation late at night: Wuhan bioremediation has resumed production
Source: State Drug Administration Editor: Eastern Fortune Network

K map 002680_2

  Q: What problems have been discovered during the flight inspection of Changchun Changsheng Biological Company? What measures have been taken?

  answer:According to the clue, from July 6th to 8th, the State Drug Administration and the Jilin Provincial Food and Drug Administration will conduct flight inspections on Changchun Changsheng Biotechnology Co., Ltd. (hereinafter referred to as Changchun Changsheng Biological Co., Ltd.); July 15th, the state The Food and Drug Administration and the Jilin Provincial Bureau formed an investigation team to conduct comprehensive investigations; on July 15, the State Food and Drug Administration issued the "Notice on Changchun Changsheng Biotechnology Co., Ltd. illegal production of freeze-dried human rabies vaccine."

Initial inspections revealed that Changchun Changsheng Biotech Co., Ltd. fabricated production records and product inspection records, and arbitrarily changed process parameters and equipment. The above acts are a serious violation of the relevant provisions of the Drug Administration Law of the People's Republic of China and the "Good Manufacturing Practices for Pharmaceutical Products" (Drug GMP). The State Food and Drug Administration has ordered enterprises to stop production, recover the GMP certificate for drugs, recall the rabies vaccine that has not been used, and file a case investigation with the Jilin Provincial Bureau. The suspected crimes are transferred to the public security organs for criminal responsibility. This flight inspection has not been shipped and listed for sale, and all products have been effectively controlled.

  On July 22, the State Food and Drug Administration deployed a comprehensive inspection of the national vaccine production enterprises. On July 25, based on the full coverage tracking inspection of 45 vaccine production enterprises nationwide in early 2018, the national regulatory force was organized. The inspection team sent a full-process and full-chain inspection of all raw materials, production, inspection, and batch issuance of all vaccine manufacturers to ensure the safety of the people.

  Q: How was the problem of unsatisfactory titer of DTP vaccine announced on November 3, 2017? What is the current situation of vaccine flow and control?

  answer:The former State Food and Drug Administration received a report from the China Food and Drug Administration Research Institute (hereinafter referred to as the Central Inspection Institute). The batch number of the Changchun Changsheng Biological Company was detected in the sample sampling test of 201605014-01, and the Wuhan Institute of Biological Products limited liability. The company's (hereinafter referred to as Wuhan Biological Company) batch number of 201607050-2 Baibai broken vaccine titer does not meet the standard.

The General Administration of Food and Drug Administration and the former National Health and Family Planning Commission immediately organized experts to study and judge, and issued notices to relevant provinces and cities to require all localities to do unqualified vaccine disposal. The first is to order the company to find out the direction. After investigation, Changchun Changsheng Biological Company produced a total of 252,600 batches of vaccines, all of which were sold to Shandong Provincial Center for Disease Control and Prevention; Wuhan Biotech produced a total of 400,520 batches of vaccines, which were sold to 190,520 of Chongqing Municipal Center for Disease Control and Prevention. It was sold to 210,000 Hebei Provincial Center for Disease Control and Prevention. The second is to immediately stop using substandard products. The third is to order the vaccine manufacturer to report the results of the factory inspection of 2 batches of unqualified vaccines, re-inspect the samples, and carefully find out the reasons for the unqualified price. The fourth is to send an investigation team to conduct investigations on the two companies and conduct on-site production system compliance inspections. The fifth is to take samples of all the white vaccination vaccines produced by the two companies within the validity period for inspection. The vaccines involved have all been sealed and the company has completed the recall.

  Changchun Changsheng Biotech Co., Ltd. has not resumed the production of DTP vaccine since last year. After the rectification of Wuhan Biotech Co., Ltd., the Central Inspection Institute conducted a titer measurement on its 30 batches of Baibai Broken Vaccine, and all the results were in compliance with the regulations, and combined with on-site inspection to resume production.

  Q: What measures does China take to ensure the quality and safety of vaccine products?

  answer:China has established a comprehensive life cycle monitoring system covering the vaccine “R&D—production – circulation – vaccination”, has a relatively complete vaccine regulatory system, regulatory system and standard management, and has established a scientific and rigorous vaccine registration and approval system, and implemented internationally advanced standards. The GMP of the drug and the strict quality management standard of the drug administration, all the listed vaccines were administered by the national batch, and a vaccination abnormal reaction monitoring report system was established.

In terms of batch issuance, in order to ensure the safety and effectiveness of biological products such as vaccines, the drug inspection agencies conduct data audits, sample inspections and issuance before each batch of products are put on the market. This supervision and management is an international regulation of biological products such as vaccines. The practice is listed by the World Health Organization as one of the key functions of governments to regulate vaccine biological products. Since December 2001, China has issued batches of five kinds of planned immunization vaccines, including Baibai, BCG, polio vaccine, measles vaccine and recombinant hepatitis B vaccine. Since January 1, 2006, all vaccines have been issued in batches. It has played an important role in regulating the production of enterprises, improving product quality, and promoting the orderly development of the industry.

In terms of vaccine production supervision, the State Drug Administration Department organizes annual coverage inspections of vaccine manufacturers. First, follow-up inspection of vaccine production quality control in accordance with GMP requirements for drugs, Chinese Pharmacopoeia requirements, and registration standards. Second, conduct flight inspections based on risk signals collected from batch issuance, national sampling, and adverse reaction monitoring. According to the defects found in the inspection, the company shall take measures such as rectification, warning letters, suspension of batch issuance, recall of related products or suspension of production.

  [Event Progress]

July 26th:Wuhan bio-made "fish of the net"? Involved in many cases of bribery, 400,000 unqualified vaccines went to the mystery

July 25th:The investigation team of the State Council went to Jilin to carry out investigation and handling of cases

July 24th:The chairman of the longevity creature, daughter-in-law, extravagant life exposure "a huge amount of fines" can not buy her 10 bags!

July 24th:State Food and Drug Administration: conducting a full process and full chain inspection of all Changchun Changsheng vaccines

July 24th:The long-lived creature will be changed to "ST Changsheng" from July 26th. The chairman and other 15 people were detained.

July 24th:Industrial Securities: Gao Junfang's son, Zhang Yihao, pledges 167 million shares of living creatures to track developments in real time

July 24th:Changsheng Biology: The chairman and some senior executives are unable to perform their duties normally. Production and operation are seriously affected.

July 24th:Longevity organisms fell for the seventh consecutive day. The Oriental Fund cut its stock price to 3.96 yuan, equivalent to 10 down limit.

July 24th:Jilin Provincial Commission for Discipline Inspection Commission initiated the investigation of corruption in Changchun Changsheng Biological Vaccine Case

July 23rd:Xi Jinping made important instructions on Jilin Changchun Longevity Biological Vaccine Case

July 23rd:Shenzhen Stock Exchange imposes restrictions on the shares held by Changsheng Bio-related shareholders

July 23rd:Public security organ investigates the suspected illegal crimes of rabies vaccine produced by long-lived organisms

July 23rd:Long-lived creatures received notice of investigation by the Securities and Futures Commission

July 23rd:"Problem Vaccine" Event Continues Fermentation Contax Bio is caught in a paradox

July 23rd:Changchun Changsheng sales agent was involved in 12 bribery cases: the four provinces involved in Henan, Guangdong and Guangdong, who are collecting money

July 23rd:Changchun Changsheng was involved in more than a dozen bribery cases: each 72 yuan rabies vaccine rebate 20 yuan

July 23rd:Is the fund manager of the first performance this year a domestic vaccine platform a rational or an interest?

July 22nd:Li Keqiang gave instructions on the vaccine incident: he must give a clear explanation to the people of the country.

July 22nd:The State Food and Drug Administration has filed an investigation! Longevity: I feel very guilty and embarrassed

July 22nd:The five major official media criticized the longevity problem vaccine: Can you apologize? Have a check!

July 22nd:Changsheng Biological Sales Director: Shandong Province has introduced a plan for the replacement of white and white

July 21st:The king of vaccines is the road to fraud: the boss of the longevity creature has grown to 5.5 billion in ten years.

July 20th:Longevity: It is expected that the rabies vaccine incident will reduce the annual income of 720 million in 2018

July 19th:Changsheng Biology: Changchun Changsheng, a wholly-owned subsidiary, received an administrative penalty decision and was fined 3.44 million yuan.

July 16th:Long-lived biological rabies vaccine production record fraud, the vaccine has not yet flowed to the market

July 15th:The State Food and Drug Administration retracted the GMP certificate for longevity biological drugs and ordered the company to stop rabies vaccine production.

  [Illustrated event]

  Graphic Gao Junfang, Du Weimin, Han Gangjun three "vaccine giants" family history

Published on 2018-07-26 00:01:56
                            Read
Published on 2018-07-26 00:02:57
                            Sofa
Posted on 2018-07-26 00:03:06
                            My son hit three stitches.
Posted on 2018-07-26 00:04:32
                            Silent at night
Posted on 2018-07-26 00:05:07
                            Midnight...
Published on 2018-07-26 00:06:48
                            Nothing, the gang has passed, even if the delisting is still a rich person, the delisting damage is the uninformed retail investors, the original defense is the most beheading, and finally only lost some wealth, unfortunately, great luck, If one survives, there will be future fortunes!
Published on 2018-07-26 00:07:24
                            My grandson played five shots!
Published on 2018-07-26 00:08:37
                            Ha ha
Published on 2018-07-26 00:09:31
                            This thing is not to say that you made a mistake and correct it! Must bear the consequences of making mistakes! Can you take out the unqualified vaccine and extract it?
Published on 2018-07-26 00:11:35
                            What should I do if I have been vaccinated? Waiting for death?
Published on 2018-07-26 00:12:36
                            Fucking, you should take all the fake bastards and shoot them.
Published on 2018-07-26 00:13:27
                            Not shooting is not enough to anger civilians.
Published on 2018-07-26 00:13:54
                            Very good
Published on 2018-07-26 00:14:15
                            Do not talk about sales rebates?
Published on 2018-07-26 00:17:37
                            Relevant information should be disclosed in a comprehensive and timely manner to eliminate panic and doubts, and to prevent some people from catching fish.
Published on 2018-07-26 00:19:43
                            Let's brush a circle of friends. Let him go.
Published on 2018-07-26 00:21:44
                            Why not destroy it!
Published on 2018-07-26 00:21:54
                            The state should set up a compensation agency for the investors of the counterfeit company, otherwise who would dare to buy a large A share
Published on 2018-07-26 00:22:11
                            Excellent performance of 000,537, high earnings per share
Published on 2018-07-26 00:22:19
                            The vaccine must not have unqualified or counterfeit, and it is related to future generations.
Published on 2018-07-26 00:22:29
                            Fly inspection? Drug test? Security check? Not flowing to the market?
Published on 2018-07-26 00:22:49
                            Wuhan Bio? ? ? ?
Posted on 2018-07-26 00:23:02
                            Strongly demanding that some laws be amended to the 1980s, corruption, fraud, direct death penalty
Posted on 2018-07-26 00:23:07
                            Sadly
Published on 2018-07-26 00:23:19
                            The flight check is a slap in the end. At present, so many children have played, what should I do next?
Posted on 2018-07-26 00:23:20
                            Wuhan Bio? ? ? ?
Posted on 2018-07-26 00:23:22
                            Open-book exam
Published on 2018-07-26 00:23:31
                            Why is this shameless company still letting it continue to produce!
Published on 2018-07-26 00:23:32
                            I’m dying, I’m already dead. Don’t worry too much. Buy 000537 quickly.
Posted on 2018-07-26 00:23:44
                            Great
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Source: State Drug Administration Editor: Eastern Fortune Network

K map 002680_2

  Q: What problems have been discovered during the flight inspection of Changchun Changsheng Biological Company? What measures have been taken?

  answer:According to the clue, from July 6th to 8th, the State Drug Administration and the Jilin Provincial Food and Drug Administration will conduct flight inspections on Changchun Changsheng Biotechnology Co., Ltd. (hereinafter referred to as Changchun Changsheng Biological Co., Ltd.); July 15th, the state The Food and Drug Administration and the Jilin Provincial Bureau formed an investigation team to conduct comprehensive investigations; on July 15, the State Food and Drug Administration issued the "Notice on Changchun Changsheng Biotechnology Co., Ltd. illegal production of freeze-dried human rabies vaccine."

Initial inspections revealed that Changchun Changsheng Biotech Co., Ltd. fabricated production records and product inspection records, and arbitrarily changed process parameters and equipment. The above acts are a serious violation of the relevant provisions of the Drug Administration Law of the People's Republic of China and the "Good Manufacturing Practices for Pharmaceutical Products" (Drug GMP). The State Food and Drug Administration has ordered enterprises to stop production, recover the GMP certificate for drugs, recall the rabies vaccine that has not been used, and file a case investigation with the Jilin Provincial Bureau. The suspected crimes are transferred to the public security organs for criminal responsibility. This flight inspection has not been shipped and listed for sale, and all products have been effectively controlled.

  On July 22, the State Food and Drug Administration deployed a comprehensive inspection of the national vaccine production enterprises. On July 25, based on the full coverage tracking inspection of 45 vaccine production enterprises nationwide in early 2018, the national regulatory force was organized. The inspection team sent a full-process and full-chain inspection of all raw materials, production, inspection, and batch issuance of all vaccine manufacturers to ensure the safety of the people.

  Q: How was the problem of unsatisfactory titer of DTP vaccine announced on November 3, 2017? What is the current situation of vaccine flow and control?

  answer:The former State Food and Drug Administration received a report from the China Food and Drug Administration Research Institute (hereinafter referred to as the Central Inspection Institute). The batch number of the Changchun Changsheng Biological Company was detected in the sample sampling test of 201605014-01, and the Wuhan Institute of Biological Products limited liability. The company's (hereinafter referred to as Wuhan Biological Company) batch number of 201607050-2 Baibai broken vaccine titer does not meet the standard.

The General Administration of Food and Drug Administration and the former National Health and Family Planning Commission immediately organized experts to study and judge, and issued notices to relevant provinces and cities to require all localities to do unqualified vaccine disposal. The first is to order the company to find out the direction. After investigation, Changchun Changsheng Biological Company produced a total of 252,600 batches of vaccines, all of which were sold to Shandong Provincial Center for Disease Control and Prevention; Wuhan Biotech produced a total of 400,520 batches of vaccines, which were sold to 190,520 of Chongqing Municipal Center for Disease Control and Prevention. It was sold to 210,000 Hebei Provincial Center for Disease Control and Prevention. The second is to immediately stop using substandard products. The third is to order the vaccine manufacturer to report the results of the factory inspection of 2 batches of unqualified vaccines, re-inspect the samples, and carefully find out the reasons for the unqualified price. The fourth is to send an investigation team to conduct investigations on the two companies and conduct on-site production system compliance inspections. The fifth is to take samples of all the white vaccination vaccines produced by the two companies within the validity period for inspection. The vaccines involved have all been sealed and the company has completed the recall.

  Changchun Changsheng Biotech Co., Ltd. has not resumed the production of DTP vaccine since last year. After the rectification of Wuhan Biotech Co., Ltd., the Central Inspection Institute conducted a titer measurement on its 30 batches of Baibai Broken Vaccine, and all the results were in compliance with the regulations, and combined with on-site inspection to resume production.

  Q: What measures does China take to ensure the quality and safety of vaccine products?

  answer:China has established a comprehensive life cycle monitoring system covering the vaccine “R&D—production – circulation – vaccination”, has a relatively complete vaccine regulatory system, regulatory system and standard management, and has established a scientific and rigorous vaccine registration and approval system, and implemented internationally advanced standards. The GMP of the drug and the strict quality management standard of the drug administration, all the listed vaccines were administered by the national batch, and a vaccination abnormal reaction monitoring report system was established.

In terms of batch issuance, in order to ensure the safety and effectiveness of biological products such as vaccines, the drug inspection agencies conduct data audits, sample inspections and issuance before each batch of products are put on the market. This supervision and management is an international regulation of biological products such as vaccines. The practice is listed by the World Health Organization as one of the key functions of governments to regulate vaccine biological products. Since December 2001, China has issued batches of five kinds of planned immunization vaccines, including Baibai, BCG, polio vaccine, measles vaccine and recombinant hepatitis B vaccine. Since January 1, 2006, all vaccines have been issued in batches. It has played an important role in regulating the production of enterprises, improving product quality, and promoting the orderly development of the industry.

In terms of vaccine production supervision, the State Drug Administration Department organizes annual coverage inspections of vaccine manufacturers. First, follow-up inspection of vaccine production quality control in accordance with GMP requirements for drugs, Chinese Pharmacopoeia requirements, and registration standards. Second, conduct flight inspections based on risk signals collected from batch issuance, national sampling, and adverse reaction monitoring. According to the defects found in the inspection, the company shall take measures such as rectification, warning letters, suspension of batch issuance, recall of related products or suspension of production.

  [Event Progress]

July 26th:Wuhan bio-made "fish of the net"? Involved in many cases of bribery, 400,000 unqualified vaccines went to the mystery

July 25th:The investigation team of the State Council went to Jilin to carry out investigation and handling of cases

July 24th:The chairman of the longevity creature, daughter-in-law, extravagant life exposure "a huge amount of fines" can not buy her 10 bags!

July 24th:State Food and Drug Administration: conducting a full process and full chain inspection of all Changchun Changsheng vaccines

July 24th:The long-lived creature will be changed to "ST Changsheng" from July 26th. The chairman and other 15 people were detained.

July 24th:Industrial Securities: Gao Junfang's son, Zhang Yihao, pledges 167 million shares of living creatures to track developments in real time

July 24th:Changsheng Biology: The chairman and some senior executives are unable to perform their duties normally. Production and operation are seriously affected.

July 24th:Longevity organisms fell for the seventh consecutive day. The Oriental Fund cut its stock price to 3.96 yuan, equivalent to 10 down limit.

July 24th:Jilin Provincial Commission for Discipline Inspection Commission initiated the investigation of corruption in Changchun Changsheng Biological Vaccine Case

July 23rd:Xi Jinping made important instructions on Jilin Changchun Longevity Biological Vaccine Case

July 23rd:Shenzhen Stock Exchange imposes restrictions on the shares held by Changsheng Bio-related shareholders

July 23rd:Public security organ investigates the suspected illegal crimes of rabies vaccine produced by long-lived organisms

July 23rd:Long-lived creatures received notice of investigation by the Securities and Futures Commission

July 23rd:"Problem Vaccine" Event Continues Fermentation Contax Bio is caught in a paradox

July 23rd:Changchun Changsheng sales agent was involved in 12 bribery cases: the four provinces involved in Henan, Guangdong and Guangdong, who are collecting money

July 23rd:Changchun Changsheng was involved in more than a dozen bribery cases: each 72 yuan rabies vaccine rebate 20 yuan

July 23rd:Is the fund manager of the first performance this year a domestic vaccine platform a rational or an interest?

July 22nd:Li Keqiang gave instructions on the vaccine incident: he must give a clear explanation to the people of the country.

July 22nd:The State Food and Drug Administration has filed an investigation! Longevity: I feel very guilty and embarrassed

July 22nd:The five major official media criticized the longevity problem vaccine: Can you apologize? Have a check!

July 22nd:Changsheng Biological Sales Director: Shandong Province has introduced a plan for the replacement of white and white

July 21st:The king of vaccines is the road to fraud: the boss of the longevity creature has grown to 5.5 billion in ten years.

July 20th:Longevity: It is expected that the rabies vaccine incident will reduce the annual income of 720 million in 2018

July 19th:Changsheng Biology: Changchun Changsheng, a wholly-owned subsidiary, received an administrative penalty decision and was fined 3.44 million yuan.

July 16th:Long-lived biological rabies vaccine production record fraud, the vaccine has not yet flowed to the market

July 15th:The State Food and Drug Administration retracted the GMP certificate for longevity biological drugs and ordered the company to stop rabies vaccine production.

  [Illustrated event]

  Graphic Gao Junfang, Du Weimin, Han Gangjun three "vaccine giants" family history