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疫苗管理法征求意见 这些违法行为将被严惩重处

作者:admin  日期:2018-11-17 13:52  人气:
疫苗管理法征求意见
 
Vaccine management law soliciting opinions
 
 
 
11日晚,国家市场监督管理总局在官网公布《疫苗管理法(征求意见稿)》,开始为期半个月的向社会公开征求意见。在舆论聚焦中,这份有关疫苗的法律征求意见稿,如何回应社会关切?给出哪些强有力的监管措施?
 
On the evening of November 11, the State Administration of Market Supervision and Administration announced the "Vaccine Management Law (Draft for Opinions)" on its official website, and began to solicit opinions from the public for half a month. In the focus of public opinion, how does the draft law on vaccines respond to social concerns? What strong regulatory measures are given?
 
 
 
 
 
 
 
征求意见稿共十一章,分别为:总则、疫苗研制和上市许可、疫苗生产和批签发、上市后研究和管理、疫苗流通、预防接种、异常反应监测与补偿、保障措施、监督管理、法律责任和附则。
 
The draft contains eleven chapters: General Provisions, Vaccine Development and Listing License, Vaccine Production and Wholesale, Post-marketing Research and Management, Vaccine Circulation, Vaccination, Abnormal Reaction Monitoring and Compensation, Safeguard Measures, Supervision and Management, Legal Liability and Supplementary Provisions.
 
 
 
征求意见稿结合疫苗研制、生产、流通、预防接种的特点,对疫苗监管的特殊要求作出具体规定:突出疫苗的战略性、公益性;加强疫苗上市监管;实施更加严格的生产管理;强化疫苗上市后研究管理;加强疫苗流通和预防接种管理;严惩重处违法行为。坚决落实“四个最严”,综合运用民事责任、刑事责任、行政责任手段,强化疫苗上市许可持有人和相关主体责任。
 
In light of the characteristics of vaccine development, production, circulation and vaccination, the draft solicits opinions and makes specific provisions on the special requirements of vaccine supervision: highlighting the strategic nature and public welfare of vaccines; strengthening the supervision of vaccines on the market; implementing stricter production management; strengthening the management of post-marketing research of vaccines; strengthening the management of vaccines circulation and vaccination; We should severely punish the illegal activities. We will resolutely implement the "four most stringent measures" and comprehensively use civil liability, criminal liability and administrative liability to strengthen the responsibilities of vaccine licensee holders and related subjects.
 
 
 
征求意见稿提出,明知疫苗存在质量问题仍然销售的,受种者可以要求惩罚性赔偿。相关违法行为构成犯罪的,依法追究刑事责任。总结近年来疫苗案件暴露的问题,对数据造假等主观故意违法行为予以严惩。落实“处罚到人”要求,强化监管部门和地方政府责任追究。参与、包庇、纵容疫苗违法犯罪行为,弄虚作假、隐瞒事实、干扰阻碍责任调查,或者帮助伪造、隐匿、销毁证据的,依法从重追究责任。
 
The draft solicits opinions that, knowing that the quality of vaccines is still on sale, the recipient may claim punitive damages. If the relevant offenses constitute a crime, they shall be investigated for criminal responsibility according to law. Summarize the problems exposed in vaccine cases in recent years, and severely punish subjective deliberate violations such as data fraud. We should implement the "punishment to man" requirement and strengthen the accountability of regulatory authorities and local governments. Those who participate in, shelter or connive in the illegal and criminal acts of vaccines, commit fraud, conceal facts, interfere with and obstruct the investigation of liability, or help forge, conceal or destroy evidence, shall be investigated for their responsibilities according to law.
 
 
 
征求意见稿还妥善处理了与药品管理法等法律的关系,明确优先适用疫苗管理法的原则。
 
The draft also properly handled the relationship with laws such as the Drug Administration Law, and clarified the principle of giving priority to the application of the Vaccine Administration Law.
 
 
 
 
 
制定法律的必要性
 
Necessity of enacting laws
 
 
 
——长生问题疫苗案暴露监管漏洞、制度缺陷
 
Long life vaccine case exposes regulatory loopholes and institutional defects
 
 
 
涉及疫苗安全,这部疫苗管理的专门法律备受关注,法律的征求意见稿由国家市场监督管理总局、国家药品监督管理局、国家卫生和健康委员会等部门共同负责起草。
 
Concerning vaccine safety, this special law on vaccine management has attracted much attention. The draft of the law is drafted jointly by the State Administration of Market Supervision, the State Drug Administration and the State Health and Health Commission.
 
 
 
国家市场监管总局网站挂出的起草说明称,疫苗关系人民群众生命健康,关系公共卫生安全和国家安全。“长春长生问题疫苗案件既暴露出监管不到位等诸多漏洞,也反映出疫苗生产流通使用等方面存在的制度缺陷。”
 
According to the drafting instructions posted on the website of the State Administration of Market Supervision, vaccines are related to people's life and health, public health and national security. "Changchun Changsheng Problem Vaccine Case not only exposes many loopholes such as inadequate supervision, but also reflects the system defects in the production, circulation and use of vaccines."
 
 
 
疫苗的战略性和公益性
 
Strategic and public welfare of vaccines
 
 
 
——国家坚持疫苗的战略性和公益性
 
The state adheres to the strategic and public welfare of vaccines.
 
 
 
《征求意见稿》开篇第一条就明确立法目的是“为保证疫苗安全、有效、可及,规范疫苗接种,保障和促进公众健康,维护国家安全”。
 
Article 1 of the draft solicits opinions makes it clear that the legislative purpose is "to ensure the safety, effectiveness and accessibility of vaccines, regulate vaccination, safeguard and promote public health and safeguard national security".
 
 
 
第五条还明确“国家坚持疫苗的战略性和公益性”。此外,国家实行疫苗全程信息化追溯制度。建立全国电子追溯协同平台,整合生产、流通、使用等全过程追溯信息,实现疫苗质量安全可追溯。
 
The fifth is also clear that "the state adheres to the strategic and public welfare of the vaccine". In addition, the implementation of the whole process of information traceability system. Establish a national collaborative platform for electronic traceability, integrate the traceability information of the whole process of production, circulation and use, and achieve traceability of vaccine quality and safety.
 
 
 
全流程的监管
 
Supervision of whole process
 
 
 
加强上市监管
 
Strengthening Listing Supervision
 
 
 
——审慎选择受试者 制定详细的受试者保护措施
 
Careful selection of subjects to formulate detailed protection measures for subjects.
 
 
 
《征求意见稿》明确,开展疫苗临床试验,须经伦理委员会审查同意,报国务院药品监督管理部门审核批准。临床试验应当由三级医疗机构或者省级以上疾控机构实施或者组织实施。
 
The draft solicits opinions clearly states that clinical trials of vaccines must be examined and approved by the ethics committee and submitted to the drug regulatory department of the State Council for examination and approval. Clinical trials should be carried out or organized by three level medical institutions or provincial or above disease control agencies.
 
 
 
此外,建立临床试验安全监测与评价制度,并根据风险制定详细的受试者保护措施。疫苗临床试验不得以婴幼儿作为受试者,审慎选择受试者,合理设置受试者群体和年龄组;受试者为限制民事行为能力人的,应当获得受试者本人及其监护人的书面知情同意。
 
In addition, a safety monitoring and evaluation system for clinical trials was established, and detailed measures for the protection of subjects were formulated according to the risks. In clinical trials of vaccines, infants and young children shall not be taken as subjects, the subjects shall be carefully selected and the subjects and age groups shall be reasonably set up. If the subjects are persons with limited civil capacity, the written informed consent of the subjects themselves and their guardians shall be obtained.
 
 
 
更严格的生产监管
 
Stricter production regulation
 
 
 
——国家实行疫苗责任强制保险制度
 
The State applies the compulsory insurance system for vaccination responsibility.
 
 
 
在疫苗生产和批签发环节,《征求意见稿》对疫苗生产实施严格准入管理,要求有足够的产能储备以应对紧急情况下的供应需求,要求法定代表人、主要负责人应当具有良好信用记录,其他关键岗位人员应当具有相应的专业背景、从业经历。
 
In the process of vaccine production and wholesale, the Draft Requests Opinions implements strict access management for vaccine production, requires sufficient capacity reserves to meet the supply and demand in emergencies, requires legal representatives and principal persons in charge to have good credit records, and other key positions should have corresponding professional backgrounds. Landscape and career experience.
 
 
 
《征求意见稿》还明确,对疫苗实施批签发管理,每批产品上市前应当经过批签发机构的审核、检验。此外,国家实行疫苗责任强制保险制度。疫苗上市许可持有人应当购买责任保险。疫苗出现质量问题的,保险公司在承保责任范围内予以赔付。
 
The draft solicits Opinions also makes it clear that the administration of vaccine wholesale should be carried out, and each batch of products should be examined and tested by the wholesale agency before they go on the market. In addition, the State applies the compulsory insurance system for vaccination responsibility. License holders of vaccines should purchase liability insurance. Where the quality of the vaccine appears, the insurance company will make a claim within the scope of coverage.
 
 
 
上市后的研究管理
 
Post marketing research management
 
 
 
——工艺落后质量不高,规定期限达不到要求的要退市
 
The quality of backward technology is not high, and the time limit is not required to be delisted.
 
 
 
疫苗上市之后,《征求意见稿》要求,疫苗上市许可持有人制定并实施上市后风险管理计划。
 
Following the introduction of vaccines, the "Draft for Opinions" requires the licensee of vaccines to formulate and implement a post-marketing risk management plan.
 
 
 
疫苗上市许可持有人应当对发生可能影响疫苗安全性、有效性、质量可控性的变更进行充分验证。疫苗生产工艺落后、质量控制水平明显劣于同品种其他疫苗现有水平的,限期进行工艺优化和质量提升,规定期限内达不到要求的,予以退市。
 
Vaccine licensee holders should fully verify changes that may affect the safety, effectiveness and quality control of vaccines. If the production technology of vaccines is backward and the quality control level is obviously inferior to the existing level of other vaccines of the same variety, the process optimization and quality improvement shall be carried out within the prescribed time limit, and if the requirements are not met within the prescribed time limit, the vaccines shall be delisted.
 
 
 
《征求意见稿》还明确,对产品设计、生产工艺、风险获益比明显劣于预防同种疾病的其他类疫苗的品种,予以淘汰。
 
The draft also made it clear that the product design, production process and risk-benefit ratio were significantly inferior to those of other types of vaccines for the prevention of the same disease, and should be eliminated.

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