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  • Liang, Yi  (4)
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  • 1
    Online Resource
    Online Resource
    Analysis of emergency Drug Approval System in China and the United States under Public Health emergencies and its enlightenment to China
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 4 ( 2022-12-15), p. 53-61
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 53-61
    Abstract: Objective: Public health emergencies, such as COVID-19, put forward a severe test to the response system of countries all over the world, including China. Especially under such conditions, the establishment and operation of the emergency drug approval system is particularly important. The purpose of this paper is to compare and analyze the emergency drug approval system between China and the United States, and learn from the experience of developed countries to improve China's drug review capability in response to public health emergencies. This paper mainly analyzes the emergency drug approval system of China and the United States under public health emergencies through literature research and comparative analysis theory. Although there are four channels to accelerate the approval of drugs for listing in China, none of them can solve the problem of emergency drug use in the face of public health emergencies, and cannot become the policy basis for the use of unlisted drugs or drugs beyond the instructions. Conclusion: On the basis of maintaining China's own institutional advantages and drawing on foreign experience, this paper puts forward relevant policy recommendations to improve China's emergency drug approval system in the event of public health emergencies.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i4.564
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 2
    Online Resource
    Online Resource
    The Enlightenment of the Management of EU Notified Bodies to China's Introduction of Third-Party Institutions for Medical Device Supervision
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 3 ( 2022-09-18), p. 54-60
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 3 ( 2022-09-18), p. 54-60
    Abstract: Objective: By introducing the pilot situation of post-market supervision of medical devices purchased by third-party institutions in Jiangsu Province, China, the problems exposed by them were analyzed. At the same time, it draws on relevant advanced experience in the management of EU notified bodies to provide suggestions for optimizing China's follow-up practices and promoting social co-governance supervision. Method: Conduct on-the-spot investigations in Jiangsu Provincial Food and Drug Administration, China, conduct interviews with regulators on the progress of the project, and conduct in-depth communication. A large number of inquiries about the relevant research literature of the EU notified body and the laws and regulations promulgated by the EU, and systematic analysis. Results: In the introduction of third-party agencies to assist post-market supervision of medical devices, the Chinese government still has problems such as lack of relevant laws and regulations, imperfect access mechanisms for third-party agencies, imperfect supervision mechanisms, and backward regulatory informatization construction. Conclusion: Introducing third-party agencies to assist in the supervision of medical devices can effectively ease the pressure on supervision and supplement supervision resources. It is suggested that the Chinese government learn from the management experience of the EU notified bodies, improve the regulatory legal system, introduce relevant regulations, improve the access mechanism of third-party institutions, improve the supervision mechanism, strengthen the construction of supervision informatization, and build a unified supervision platform.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i3.553
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 3
    Online Resource
    Online Resource
    Analysis on the registration and review system of emergency medical devices in China and abroad in the context of COVID-19
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 2 ( 2022-06-19), p. 46-55
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 2 ( 2022-06-19), p. 46-55
    Abstract: Objective In the context of COVID-19, the domestic and foreign demand for emergency medical devices, such as medical masks and protective suits, is surging, and it is urgent to complete the registration and review of emergency medical devices with high efficiency and quality, which requires a mature and perfect registration and review system as the support. This paper aims to compare and analyze the domestic and foreign registration and review system of emergency medical device, summarize the good experience, and provide feasible suggestions for improving China's emergency medical device registration and review system. Method USA, Canada, Japan and the European Union were selected to make a comparative analysis with China from the aspects of legal system and emergency registration and review procedure by literature research, comparative analysis and other theoretical methods. Results The legal system and review mechanism of emergency medical device registration in China have been relatively perfect, but the safety and risk balance mechanism and the comprehensiveness of emergency management measures need to be further improved. Conclusion On the basis of maintaining its own institutional advantages, China should learn from foreign experience to further optimize the registration and review system of emergency medical devices, so as to improve the ability of response and implementation of China in public health emergencies.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i2.522
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 4
    Online Resource
    Online Resource
    Research on Quality Control Strategy of CAR-T Cell Therapy Products based on QbD
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 4 ( 2022-12-15), p. 62-74
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 62-74
    Abstract: Objective: This paper aims to provide reference for how to use the concept and method of QbD to control the quality of CAR-T cell therapy products in the commercial production of CAR-T cell therapy products in China, and how to formulate reasonable and effective quality control strategies. Methods: This paper systematically analyzes the industrial development of CAR-T cell therapy products and the concept, application methods and implementation process of QbD in China through literature research and case analysis theory Results: Cell therapy products are a hot area in the research and development of new drugs, but at present, there are no specific regulatory rules in the commercial production of CAR-T cell therapy products in China, the awareness of risk control is weak, and the quality control is unstable, making patients face many risks. Conclusion: Based on the concept of QbD, the quality control strategy of CAR-T cell therapy products was proposed from three dimensions.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i4.565
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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