echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > "Vaccine Law" plus: the advantages highlighted, the industry is new

    "Vaccine Law" plus: the advantages highlighted, the industry is new

    • Last Update: 2021-02-14
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    It has been more than a year since the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Law) was officially implemented on December 1, 2019.
    This special law, which includes 11 chapters on general rules, vaccine development and marketing permits, vaccine production and approval, vaccine circulation, vaccination, abnormal reaction monitoring and treatment, post-market management of vaccines, safeguards, supervision and management, legal liability and by-laws, has changed the situation in Which China's vaccine management system has been decentralized in several laws, such as the Drug Administration Law, the Regulations on the Administration of Infectious Diseases.
    The Vaccine Law is a chain-wide integration of previously dispersed provisions on vaccine development, production, circulation, vaccination, abnormal reaction monitoring, safeguards, legal liability, etc., but it is not only a simple convergence of regulations, learning from practical experience at the same time, there are many innovations and bright spots.
    more than a year of implementation, these bright spots gradually highlight the advantages and values in practice.
    seamless control of the entire vaccine management chain long, many links, the establishment of the whole process from vaccine development registration, production, circulation, vaccination to post-market management of the whole process of supervision system for one year, showing advantages.
    of the Vaccine Act, which provides for "full control", is also the biggest highlight of the Vaccine Act.
    Article 5, paragraph 1, of the Vaccine Law stipulates that the licensed holders of vaccines shall strengthen the quality management of the whole life cycle of vaccines, and paragraph 2 stipulates that units and individuals engaged in vaccine development, production, circulation and vaccination activities shall ensure that the information of the whole process is true, accurate, complete and traceable.
    this reflects the concept of full control.
    10 of the Vaccine Law of the People's Republic of China stipulates that the State shall implement an electronic traceability system for the entire course of the vaccine.
    system will help vaccine information to be traceable, source traceable, process controllable and accountable.
    control of vaccine management is reflected in the sections of the Vaccine Act.
    Chapter II of the provisions on vaccine development, emphasizing the development process of biosecurity control and strain management requirements, vaccine clinical trials have also made special management provisions, requiring careful selection of subjects, vaccine clinical trials should be organized by three or more medical institutions or above the provincial disease control agencies to implement.
    Chapter III of the provisions on vaccine production, the implementation of strict production access management, to engage in vaccine production activities to have a moderate scale, production capacity reserves and to ensure biosecurity systems and facilities;
    Chapter IV of the management of vaccine circulation, requires the vaccine by the listed license holder in accordance with the procurement contract, directly to the disease control agencies, disease control agencies in accordance with the provisions of the supply to the vaccination units, distribution of vaccines in accordance with the vaccine storage, transportation management norms; Chapter V of the
    "Prevention of Vaccination" is a provision on the use of links, strengthening and refining the requirements for disease prevention and control institutions, vaccination units and medical and health personnel: Article 44 stipulates the conditions of the vaccination unit, requires the vaccination unit to strengthen internal management; the whole control of
    vaccine helps to control the whole life cycle chain of vaccine effectively, promotes the subject to fulfill the corresponding obligation, defines the responsibility of different subjects, helps the regulatory authorities to carry out risk supervision on the basis of information, and helps to protect the consumer's right to know and choose.
    Before the introduction of the Vaccine Law, the punishment of vaccine management regulations was insufficient, and the low cost of violating laws and regulations led to poor self-discipline of enterprises, often taking risks for profit and increasing the risk of the emergence of the problem vaccine.
    highlight of the vaccine law is the harshest penalties.
    article 1 of the Legal Liability Chapter of the Vaccine Law clearly states that "if a violation of the provisions of this Law constitutes a crime, criminal responsibility shall be re-investigated in accordance with the law".
    also impose penalties on persons responsible for serious violations, and increase penalties for administrative detention.
    In addition, the legal liability part strengthens credit discipline, requires the establishment of credit record system, serious violations are included in the national credit information sharing platform, publicity of vaccine listing license holders and related personnel of serious breach of trust information, the implementation of joint disciplinary.
    set a far higher penalty than ordinary drugs, such as the production and sale of vaccines belonging to counterfeit drugs, and illegal production and sale of vaccines worth 15 times the value of 50 times the fine;
    strict penalties to a certain extent increase the cost of illegality and violation of the law, will prompt enterprises to pay attention to the legal bottom line, reduce the risk of the problem vaccine.
    Before China's vaccine regulations are scattered in various places, all kinds of regulatory agencies "one paragraph at a time", the lack of more systematic and professional regulatory force, the "vaccine law" carried out legal integration, for the vaccine regulatory capacity to make new requirements and regulations.
    because vaccines are high-risk and highly specialized drugs, we should strengthen the capacity-building of the vaccine regulatory team and form a vaccine regulatory and technical support team that is appropriate to the regulatory task.
    71 of the Vaccine Administration Law stipulates the system of drug inspectors and stipulates that "the State shall build a team of professional and specialized drug inspectors at the central and provincial levels to strengthen supervision and inspection of vaccines".
    industry development has revealed that the sharp-angle vaccine is a special drug, is a national strategic, public welfare products, is to protect human health and public health of the basic public products, is the prevention and control of infectious diseases and epidemic of the most economical and effective measures.
    safety is directly related to the implementation of China's immunization planning policy, is directly related to public health of major livelihood issues.
    of the First Provisions of the Vaccine Act is to "promote industry development", reflecting a balance between safety, development and innovation.
    more than a year, the Vaccine Law has also played a real role in the implementation of vaccine management, in addition to promoting the quality of vaccines in China, enhance people's confidence in vaccine safety, but also promote the healthy development of the vaccine industry.
    The Vaccine Act is not only from the legislative point of view, the whole chain of vaccines, the full cycle of strong supervision, to ensure the safety of vaccine production and supply, conducive to industry norms, health and sustainable development.
    More crucially, to support active innovation in the industry, Article 15 of the Vaccine Law stipulates that "the State shall encourage vaccine licensing holders to invest more in research and innovation, optimize production processes, improve quality control and promote technological progress in vaccines".
    the background of epidemic prevention and control, pharmaceutical enterprises are gradually accelerating the accumulation of technology, vaccine industry innovation and upgrading is expected to accelerate.
    , the Vaccine Act supports the development and structural optimization of the vaccine industry and encourages the large-scale and intensive production of vaccines.
    Article 4, paragraph 3, of the Vaccine Law states: "The State formulates development plans and industrial policies for the vaccine industry, supports the development and structural optimization of the vaccine industry, encourages the scale and intensive production of vaccines, and continuously improves the production process and quality of vaccines."
    " With the continuous improvement of vaccine production quality, industry standards further improved, enterprises that do not meet the requirements will gradually withdraw, the industry will accelerate the survival of the fittest, state-owned enterprises and large-scale backbone enterprises more prominent leading role, high-quality enterprises will be further reflected in the advantages of scarcity.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.