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    Home > Active Ingredient News > Drugs Articles > As the supervision of vaccine industry becomes more and more strict, it is proposed to assign resident supervisors to enterprises

    As the supervision of vaccine industry becomes more and more strict, it is proposed to assign resident supervisors to enterprises

    • Last Update: 2019-01-08
    • Source: Internet
    • Author: User
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    [China Pharmaceutical network industry trends] in the first half of 2018, the highly publicized vaccine event in the pharmaceutical industry attracted the continuous attention of the social and regulatory authorities Although the vaccine incident has come to an end, the supervision of the vaccine industry will become more and more strict next The vaccine management system will be further improved In September 2018, the opinions on reforming and improving the vaccine management system was passed It requires that the vaccine management system be reformed and improved, market access be strictly enforced, market supervision be strengthened, circulation and distribution be optimized, vaccination be standardized, relevant laws and regulations be improved, and outstanding problems such as low illegal cost and weak punishment of vaccine drugs be solved as soon as possible Vaccine supervision will be more strict On November 11, 2018, the State Administration of market supervision and administration put the vaccine management law on the Internet for comments It is reported that previously, vaccine management mainly relied on the "Regulations on vaccine management" and "drug management law", mainly referring to the general drug standards to regulate the development and production of vaccines, which is easy to cause oversight Vaccines are more special than general drugs, so once the "vaccine management law" is promulgated, it means that the supervision of vaccines will be more scientific and strict   For example, the vaccine management law stipulates that the domestic vaccine marketing license holder and production license holder can only be the same subject; the vaccine procurement authority shall be returned to the provincial disease prevention and control institutions; after the vaccine is launched, the risk management plan shall be required If the vaccine production process of an enterprise is backward and the quality control level is significantly lower than the existing water of other vaccines of the same variety Ping, the company's vaccine products may face delisting Vaccine supervision is becoming more and more strict, and the management system is more perfect, urging vaccine enterprises to move forward on the road of reasonable compliance, and further ensuring the safety of people's vaccination The illegal cost has been greatly increased According to the provisions of the vaccine management law, vaccine manufacturers that are seriously in violation of the law will be "confiscated of their illegal income, ordered to stop production and business, revoked the listing license documents, and imposed a fine of not less than five times but not more than ten times the value of the goods"   If the value of the goods of the enterprise is less than 500000 yuan, then "a fine of not less than 1 million yuan but not more than 5 million yuan shall be imposed, the legal representative, main person in charge and key post personnel of the vaccine marketing license holder shall be confiscated, the income obtained from the unit during the illegal period shall be confiscated, and a fine of not less than 50% but not more than one time shall be imposed, and no drug production and marketing activities shall be carried out within ten years " It can be seen that the illegal cost of vaccine manufacturers has been greatly increased, which is also a wake-up call for vaccine manufacturers to reasonably produce safe and high-quality products It is reported that the State Food and drug administration plans to set up a vaccine supervision and research center to send in plant supervisors to vaccine enterprises "Generally, there are three lines of defense for drug quality: first, the supervision of the enterprise itself, and the QA department (quality assurance department) can play a normal role Second, GMP certification Third, the system of resident supervisors " Industry insiders said so The author understands that, in fact, the resident supervisor system was implemented in the early years, but some "problem vaccines" still flow into the market, and the resident supervisor system is nothing However, this time, the resident supervisors will be different from the past, not only with a legal basis, but also with a legal identity In addition, the industry said that the inspectors stationed in the factory will be responsible for the behavior during the period of dispatch for life, and will be responsible for the dereliction of duty and dereliction of duty for life It can be seen that the state attaches great importance to the safety of vaccines, and the vaccine industry will develop better in the future under layers of supervision.
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