Recently，The Standing Committee of the National People's Congress first reviews the draft of the Drug Management Law，Compared with the current Drug Management Law，At least six "vaccine clauses" were added to the draft amendment，Strengthen the supervision of special drugs such as vaccine。

Key supervision and inspection of "vaccine"

The current drug management law only explains the meaning of "drug" in the law，The word "vaccine" was mentioned，Clear "medicine" in the law includes vaccine，In addition，No specific regulations on the vaccine。Compared with this，At least 6 "vaccine clauses" were added to the draft amendment，In addition to the situation stipulated by the drug regulatory department，Vaccine and other special drugs shall not be commissioned to produce; implement the vaccine liability for compulsory insurance system，Listing permit holders of the vaccine shall be insured in accordance with relevant national regulations;、Production、circulation、Informatization methods should be collected during the vaccination process、Reserved retrospective information; the drug stake betting appsupervision My stake betting appand management department shall implement key supervision and inspection of biological products such as vaccines。

Multi -Fa -thinking ideas: Divide the Code of the Code, go to remove the disadvantages

Jiao Hong, director of the State Drug Administration, said: The overall idea of ​​this amendment "First is to implement the requirements of General Secretary Xi Jinping's" four most "，Persist in the healing and chaos，Go to remove disadvantages，Strengthen the entire process supervision，Resolutely keep the bottom line of public safety。Second, the prominent problem of exposure around the problem of vaccine cases、Implementation of a drug listing license holder system and promoting the reform of the trial system to modify，Timely respond to social concerns，For other less urgent need, make a modification when the next step is fully revised。”

Partial "vaccine clause"

Article 33 Drug listing license holder to produce drugs，The "Drug Production License" shall be obtained in accordance with the provisions of this Law;，It should be selected for eligible pharmaceutical manufacturers。Vaccine、Blood Products、Anesthesiologist、Psychiatric drugs、Medical toxic drugs must not be commissioned to produce; but，The State Council's Drug stake betting appsupervision My stake betting appand management department stipulates that the situation that can be commissioned except。

Article 35 Drug Local License Holders、Production Enterprise、Business Enterprise、Medical institutions shall establish and implement strict drug quality and safety traceability system，Guarantee drugs traceable。

Development of vaccine、Production、circulation、Informatization methods should be collected during the vaccination process、Reserve traceable information。

Article 36 The state of the state implemented vaccine liability for compulsory insurance。Listing permit holders of the vaccine shall be insured in accordance with relevant national regulations。

Article 48 The state implements My stake betting appa drug reserve system，Establish a central and local two -level drug reserves。

Listing My stake betting apppermit holders of vaccine and shortage drugs to stop production，Report to the drug stake betting appsupervision My stake betting appand management department of the State Council in accordance with regulations。

Article 68 The drug stake betting appsupervision My stake betting appand management department has the right to follow the law、The provisions of administrative regulations shall be reported to the drug development and production of drugs and the production of drugs、Operations and medical institutions using drugs for supervision and inspection，If necessary, you can develop drugs、Production、Business、Units and individuals using products or services for extension inspections，Relevant units and individuals must not refuse and conceal。

The drug stake betting appsupervision My stake betting appand management department shall implement key supervision and inspection of biological products such as vaccines。It is found that there may be hidden safety hazards，Drug Supervision and Administration Department according to supervision and inspection，You can adopt a warning、Responsible interview、Rectification within a time limit、Order recall and suspension of production、Sales、Use、Import and other measures，and promptly announce the results of the inspection processing。

Article 100 production、Sell vaccines and other biological products are fake medicines、Bad drugs，Study penalties within the punishment stipulated in this law。Production、Sales of punishment for fake and shoddy vaccine is intended to be mentioned to "more than five times less than fifteen times"。At the same time, stipulate，There are production and sales of fake and shoddy medicine、Activity of violating quality management specifications，The legal representative or main responsible person of the unit、Direct responsible persons in charge and other directly responsible persons to confiscate income、Power of fines、Punishment for ten years or even lifetime ban。

Refusal to recall the implementation of production and operation licenses

According to the Stake Sports Bettingdraft，Pharmaceutical listing license holder、Production and business enterprise、Medical institutions should establish、Implement strict traceability system，Make sure the entire process data is true、Accurate、Complete and traceable;，Should stop production immediately、Business，Recall of the drugs that have been listed and sold，and publish recall information in time，Report the drug recall and treatment situation to the provincial, district, municipal drug stake betting appsupervision My stake betting appand management department and the health administrative department。If it should be recalled, it is not recalled，The drug supervision department may order it to recall。

If you are ordered to recall，Drug listing holders still refuse to recall，So the amount of the value of the recalled drug value of more than five times or less will be punished，If the plot is serious, it will be revoked "Drug Production License"、"Drug Business License"。

Concealing the Drug Safety Accident Display

Draft proposal，If the drug supervision department fails to discover the systemic risk of drug safety or eliminate hidden dangers in time，So the people's government at the people at the same level or the pharmaceutical supervision department of the people's government at the higher level shall conduct a responsibility interview with the responsible persons of its main responsible person;，Not eliminated major hidden dangers in time，Then the drug supervision department of the higher -level people's government or the people's government at the higher level gives a responsibility interview with its main responsible person。

Standardized at the same time，If three situations occur，Governments at or above the county level can be directly responsible for the person in charge and other responsible persons.，Give a downgrade、Withdrawal or fired punishment。These three situations include: poor performance，What causes serious adverse effects or major losses; concealment、Lie Bao、Slowly reporting drug safety stake sports betting appMy stake betting appaccidents; particularly major drug safety accidents in this administrative area，or a major pharmaceutical safety accident。

If the drug supervision department concealed、Lie Bao、Slowly reported drug safety accidents，or the discovered drug safety violations have not been investigated and punished in time，According to the provisions of the draft，Direct responsible supervisors and other direct responsible persons will also be remembered or sanned;，Give a downgrade、Disposal punishment; if the circumstances are serious，Give fired punishment。

In addition，The draft also stipulates the "Joint Disciplinary System"，Requires the drug supervision department to establish and publish drug safety credit files，Increase the frequency of supervision and inspection for units with bad credit records，Perform joint punishment for units with severe violations of laws。