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| The review process for recombinant ebola vaccine will be accelerated |
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| Author：中國銘鉉 企劃部 Release Time：2017-9-5 11:40:27 Number Browse：780 |
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Medical network - on September 5, in order to speed up the reorganization of the ebola virus disease vaccine listed the review process, discuss the Ⅲ period under the situation of unable to carry out clinical trials, research and development for major public health problem of the path of the emergency vaccine registration listed and technical evaluation standards, the scientific nature of the security review and rigour, human medicinal center recently held a reorganization of the ebola virus disease vaccine expert consultation meetings, important technical problems in the process of public consultation for vaccine evaluation expert advice. Sun xianze, deputy director of the state administration of food and drug administration, and xu jiazi, director of the pharmaceutical audit center, attended the meeting and spoke. Restructuring of the ebola virus disease vaccine by the Chinese people's liberation army military academy of medical sciences, biotechnology research institute and the joint declaration Kang Xinuo biological co. LTD., be used to prevent ebola virus disease caused by the ebola virus.
Include priority review procedures
The ebola virus is a kind of can cause deadly infectious diseases of humans and primates produce ebola haemorrhagic fever virus, because of its high fatality rate by the world health organization as one of the most severe virus harm to human beings. The virus has broken out in Africa since it was first discovered in 1976, with the worst outbreak in west Africa in 2014. According to the world health organization, 1.13 million people were killed. Since there are also viruses in the survivors, there is still a risk of imported cases.
In recent years, China's public health system construction has made great progress, but in the face of a global outbreak of public health events, vaccine in China in such aspects as research, production, supply and institutional deficiencies, vaccine products listed conditional approval system has not yet been fully established. Restructuring of the ebola virus disease vaccine aimed at the special needs of national strategy, its listing review to improve vaccine conditional approval system and emergency vaccine filing registration, increasing the state relating to the major public health events related to the vaccine r&d is of great significance.
On February 13, 2015, the recombinant ebola vaccine was approved by the general administration for clinical trials of drugs. Human medicinal center attaches great importance to the review of the product, to boost its listed as soon as possible, in November 2016, according to the administration of the drug research and development and technical evaluation measures for the management of communication (try out) "regulation, such as organizing communication exchange meeting, after the product of new drug applications, from medicine, clinical pharmacology and toxicology and statistics, conducted a comprehensive communication with the applicant. In April 2017, applicants are registered with the biological products 1 class. The pharmaceutical audit center, according to the general administration's opinion on the review and approval of the approval of drug registration, has been audited and made to the priority review process in early June. Subsequently, the pharmaceutical audit center quickly organized a number of communication meetings and experts to provide guidance and support for the development and declaration of the product.
Further research is needed
The meeting, report to the conference center of human medicinal vaccine indications team reorganized the ebola virus disease vaccine, the review process, the basic situation of the global ebola vaccine research progress, and so on and so forth, from medicine, clinical pharmacology and toxicology, biological statistics, puts forward the specific consultation with experts. The applicant reported the research background of the vaccine, key quality attributes, process and characteristics of the product, and clinical results. From epidemic, pharmacy, pharmacology and toxicology, immunization, experts in the field of statistics such as how to human medicinal center according to the existing clinical study evaluating the effectiveness of the product to prevent ebola virus disease, vaccine safety and product quality control and other issues respectively published opinions, the applicant and the reply on the relevant questions.
, experts say, the ebola virus infected regular outbreaks, high fatality rate after infection, as one of the important ways to prevent such a virus infection, the success of the reorganization of the ebola virus disease vaccine research and development is not only for our country in global public health events can effectively control the outbreaks in provides the security, will also promote major infectious disease vaccine research and development in China and leading role. Expert thinks, restructuring the ebola virus disease vaccine is based on the ebola virus disease epidemic research and development products, special in popular intermittent period, the disease is difficult to provide large sample size crowd effectiveness data, still needs further research, but according to the safety and immunogenicity of data obtained from the existing research, Suggestions can be used as a national reserve conditional approval, used to deal with the emergency in effect at the time of the outbreak, and to carry out Ⅲ phase of clinical trials.
Human medicinal center of biological medicine division, department of biological products LinChuangBu, pharmacology and toxicology, statistics and clinical pharmacology department review, business management departments, the project manager to attend the meeting.
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