| 孙昱.新发传染病相关的药品技术战略储备思考[J].中国药事,2020,34(3):266-274 |
| 新发传染病相关的药品技术战略储备思考 |
| Considerations on Strategic Reserves of Pharmaceutical Technologies Related to Emerging Infectious Diseases |
| 投稿时间：2020-02-20 |
| DOI：10.16153/j.1002-7777.2020.03.003 |
| 中文关键词: 公共健康威胁 新发传染病 大流行防备疫苗 技术战略储备 新型冠状病毒肺炎 |
| 英文关键词: public health threat emerging infectious disease pandemic preparedness vaccine strategic reserves of technology corona virus disease 2019 |
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| 中文摘要: |
| 目的： 对新发传染病相关的药品技术战略储备进行探讨，旨在为战胜此次新冠肺炎疫情，更为下一次可能的疫情做好准备。方法： 梳理了世界卫生组织、欧盟、美国对与公共健康威胁相关的药品技术储备情况，主要阐述了新发传染病相关的疫苗技术储备信息，给出WHO建议的新型冠状病毒肺炎（COVID-19）药品研发信息，EMA在公共健康威胁（例如大流行性流感）相关药品方面的技术储备情况，并总结了EMA对大流行防备疫苗的技术要求。结果与结论： 建议在我国建立由国家主导并投资的与公共健康威胁相关的预防用疫苗或治疗用药物的技术和产品战略储备，例如为新发传染病的疫苗开发制定清晰的计划、法规和程序。药品技术和产品的战略储备可包括：1）政府部门制定与公共健康威胁相关疾病的清单，例如可能引起重大流行病的突发疾病用药优先研发清单；2）审评审批方面可考虑制定大流行性疾病疫苗（包括大流行防备疫苗）、大流行性疾病治疗药物研发的技术要求，涉及质量、非临床、临床、申报程序等内容；3）通过国家科技立项等方式投资预防用疫苗及治疗用药物的研制；4）引导生产企业进行相关的药品战略储备。 |
| 英文摘要: |
| Objective: To discuss the strategic reserves of pharmaceutical technologies related to emerging infectious diseases, with a view to overcoming corona virus disease 2019 (COVID-19) and preparing for the next possible outbreak. Methods: The technical reserves of pharmaceutical technologies related to public health threats of the World Health Organization (WHO), the European Union, and the United States were analyzed. The technical reserves of vaccine technologies related to emerging infectious diseases were mainly elaborated. Information on the research and development (R&D) of drugs for COVID-19 recommended by WHO, the technical reserves of pharmaceutical technologies related to public health threats (such as pandemic influenza) of EMA were put forward. Technical requirements for pandemic preparedness vaccines of EMA were summarized. Results and Conclusion: It is suggested that nationally-led and invested strategic reserves of technologies and products of preventive vaccines or therapeutic drugs related to public health threats in China should be established. For example, clear plans, regulations and procedures should be made for the development of vaccine for emerging infectious diseases. The strategic reserves of pharmaceutical technologies and products are as follows:1) a list of diseases related to public health threats should be developed by government agencies, such as a priority R&D list of drugs for emerging diseases that may cause major epidemics; 2) as far as review and approval are concerned, consideration may be given to formulating technical requirements for the pandemic vaccines (including pandemic preparedness vaccines) and R&D of therapeutic drugs for pandemic diseases, including quality, nonclinical, clinical, and application procedures; 3) development of preventive vaccines and therapeutic drugs should be invested through national scientific and technological projects; 4) manufacturing enterprises should be guided to carry out strategic reserves of relevant pharmaceutical products. |
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