New law to better regulate vaccine industry By Wang Hairong:ABoosterShotOfLegislation论文

New law to better regulate vaccine industry By Wang Hairong:ABoosterShotOfLegislation论文

A child gets inoculated in the disease prevention and control center of Xinle City in Hebei Province on April 25, a national vaccination publicity day

A vaccine administration law was adopted by the National People’s Congress(NPC) of China, the top legislative body of the country, on June 29, marking the beginning of improved vaccine administration.The law will go into effect on December 1.

重点协调解决项目审批过程中的具体困难和问题,一般问题由代办员协调项目审批服务中心并跟踪督办;项目审批中心不能解决的问题,由县审批服务中心领导召集,以联审会议形式协调;需要县政府解决的问题,及时报送县政府领导协调。通过这样的运行机制,有效推动项目顺利实施,使项目在代办过程中不“卡壳”,不“回头”,不“转圈”。

Whole process supervision

As biological products used on healthy people, mostly infants, vaccines pertain to public health, and hence to public safety and national security, said Jiao Hong, head of the National Medical Products Administration(NMPA), at a press conference on June 29 at the Great Hall of the People to announce the adoption of the law.

第五,截桩。在完成预顶、全面观测变形稳定后,进行锁定,开始截断被托换桩,断柱采用人工截除,由外及内层层剥离的施工方法。截柱前需对原桩沉降及新旧混凝土界面滑移做好观察,在截柱过程中实行不间断观测,做到信息化施工。

“Vaccine supervision will cover the whole process, from vaccine development, production and distribution to vaccination,” she said, noting that in light of their unique characteristics, vaccines should be subject to the strictest regulation.

According to the law, an electronic information system will be set up to make all information of vaccines traceable, including information about vaccine production and packaging, period of validity, date of vaccination, along with the medical workers who conduct the vaccinations and vaccine recipients.

In addition, market access to vaccine production is to be strictly controlled.Producers will be required to not only comply with the drug administration law, but also rules specific to the vaccine industry.

教师若单纯依靠小学语文教材开展童话教学,把学生的童话学习定格在书本世界里,而忽视教学内容与实际生活的联系,会束缚学生阅读思维能力的提高,使小学语文童话教育失去实践和应用的价值,不利于丰富学生的情感体验和培养学生的综合实践能力。为此,教师应当将课上课下两个课堂结合起来,注重课外教学对学生知识巩固的重要作用,通过组织演讲比赛、故事表演等多种形式的课外活动,丰富学生的情感体验,使学生在参与活动的过程中逐渐提高自身的童话理解能力和语文综合素养。

They must have appropriate capacity and facilities to ensure biosafety. Their legal representatives and their principal heads should have good credit records, while people in other key positions should have competent professional backgrounds and experience.

Moreover, the law demands strict process control. Vaccine production must follow proper procedures and quality control standards, after-sale research should be actively carried out and the production process should be continuously optimized. Changes that may affect the safety and efficacy of vaccines should be adequately validated,while every batch of products should be tested and approved by regulators before going onto the market.

Professional vaccine inspection teams will be established at the central and provincial levels to conduct supervision, Yuan said, adding that there are no more than 100 vaccine inspectors at the national level currently, which is completely inadequate.

Legal representatives, principal responsible persons, directly responsible persons,as well as other responsible persons in a law-violating organization shall be severely punished, Jiao said.

The law spells out specific requirements for every link of vaccine administration and requires stringent research and development management. For instance, it stipulates that clinical trials of vaccines can only be conducted by qualified medical institutions or disease control authorities,and subjects for clinical trials should be carefully selected.

The law emphasizes information disclosure and sharing, said Yuan Lin, Director of the medical products supervision division of the NMPA, at the press conference. Vaccine license holders are mandated to release product and other relevant information to the public in a timely manner.

入侵检测技术是通过对审计数据及其他网络信息进行操纵,检测计算机网络外部对系统的入侵行为或企图。入侵检测技术是一种积极主动的计算机网络安全防范技术,不仅可以防护来自外部的攻击,对网络安全进一步强化,而且可以在一定程度上来弥补防火墙技术的不足。

Punishment and compensation

The law is a response to problems exposed in vaccine administration recently. In particular, last year, a scandal involving Changchun Changsheng Biotech Co. Ltd. in northeast China’s Jilin Province put vaccine production and administration under scrutiny.

On July 15, 2018, the NMPA announced that the company was found to have falsified production records in making rabies vaccines for human use. Last October, the Jilin Food and Drug Administration revoked the company’s pharmaceutical production license and confiscated illegally produced vaccines and 1.89 billion yuan ($274 million)of pro fi ts from sales of defective vaccine. It also imposed a fine of 7.21 billion yuan ($1.05 billion).

Hefty punishment is conducive to enhancing the quality of the country’s vaccines and boosting the public’s confidence of vaccine safety, said Jiao.

Under the new law, penalties for illegal acts involving the production and sale of fake or inferior vaccines, falsifying vaccine registration data and violation of relevant quality standards will be much higher than those involving ordinary drugs.

Compensation for damage incurred by mandatory vaccinations will be paid from local fiscal revenue; while damage from voluntary vaccinations will be paid by vaccine license holders, according to the law.

In addition, the minimum fine for producing or selling fake or substandard vaccines was raised, and vaccines worth less than 500,000 yuan ($72,900) will be fined as much as those worth 500,000 yuan.

It states that the government supports basic research and innovation in vaccines, including providing necessary funding for the development of new types of vaccines such as polyvalent vaccines, and joint research and development among vaccine license holders as well as research and medical institutes. The government has always bolstered the structural optimization of the vaccine industry, encouraging large-scale and intensive production.

式中,W′维数为s×m,θ2为阈值,维数为m×1,f2(I2)为输出层的传递函数,可采用Sigmoid函数或Purelin函数。

Furthermore, the law provides for strict control of vaccine distribution, where vaccines will be directly delivered to disease control authorities and then distributed to vaccination units. The distribution process should be traceable in real time to ensure vaccine quality.

In addition to penalties, the law also introduces a compensation scheme for people who suffer side effects from vaccinations.

(四)在免疫、检疫、监督的同时录入信息 通过对县、乡、村人员层层培训,让他们熟悉、掌握了挂标及通过识读器信息录入的方法。从2007年起州、县、乡每年投入官方兽医787人,村协检人员1 230人参与挂标、基础信息录入和免疫、产地检疫、屠宰检疫信息录入工作,到目前,共录入养殖户的基础信息5.8万条,戴标579 483条、免疫2 060 858条、产地检疫9 467条、出县境检疫53 576条的信息录入,上传中央数据库。为信息查询提供了坚实的基础保障。

Those producing or selling fake vaccines will face a fine of 15 to 50 times the value of the illicit products, while substandard vaccine makers or sellers face a fine of 10 to 30 times the value.

Big industry

In addition to provisions on the wholeprocess supervision, the law also specifies measures encouraging innovation in vaccine development, Jiao explained.

据了解,世界肥料大会是由国际肥料科学中心组织的与肥料有关的序列会议,也是肥料领域和行业内首屈一指的国际性会议,在世界肥料领域中拥有很大影响力的顶级会议。世界肥料大会的召开,为中国科学家和企业了解世界肥料科学研究的现状和产业发展趋势,学习交流肥料研发生产和应用的先进经验,解决我国肥料利用率低和环境问题,全方位宣传我国肥料研究、企业生产和应用的成果提供了高层次的平台。本次大会对加快土壤营养与肥料学科发展,促进我国肥料行业健康快速发展,实现化肥零增长目标具有重要意义,是落实生态文明建设国家基本方略和绿色发展理念的一次科学实践。

The new law also makes it clear that violation of its provisions constitutes a criminal offense, therefore perpetrators will be investigated for criminal responsibility according to relevant law.

In the past four decades, China’s vaccine industry has grown rapidly, Jiao said,adding that China has 45 vaccine producing enterprises, with a combined annual production capacity exceeding 1 billion doses.Altogether, they can produce more than 60 types of vaccines against 34 diseases,with four of them pre-certified by the World Health Organization and exported to more than a dozen countries and regions.

China has been an example for many countries for many years with its support for child vaccination programs at home and abroad along with policies and actions,said Seth Berkley, CEO of GAVI, the Vaccine Alliance, at the opening ceremony of the Global Health Forum of the Boao Forum for Asia on June 11.

式中,t为模型计算时间;u、v分别为潮流流速沿x、y方向的分量;h为无波浪情况下的静水深;ζ为波浪作用引起的水位变化值;f为柯氏参数;g为重力加速度;Ex、Ey分别为风荷载粘性系数在x、y方向的取值;τbx、τbx分别为潮流剪应力沿x、y方向的分量。

Vaccination is one of the best investments in global health; it is the most costeffective with a huge impact, he said. Since the 1970s, global immunization coverage for children has increased from only 5 percent to 86 percent, leading to a 60 percent drop in the child mortality rate, he said.

随着我国城镇化步伐的加快,形成城乡二元结构,城乡之间的差距不断扩大,也使学校教育出现一些问题。城镇化的主要表现就是大量的农村务工人员向城市流动,伴随着大量的农村学生与父母向城市的流动,给城镇和农村学校的布局、办学容量以及生源、师资力量都带来很大的影响和改变。

“Vaccination has played a multifaceted role in protecting people’s health and promoting the construction of a healthy China,” said Cui Gang, Deputy Inspector of the Disease Prevention and Control Bureau of the National Health Commission, at the press conference announcing the law.

He cited the examples of smallpox, polio and diphtheria, which were previously serious threats. Smallpox was eliminated in China in 1979, polio after 2000, and diphtheria after 2006, he said.

China once had a very high incidence of Hepatitis B at 9.7 percent. But since the vaccine against the virus was included in the Chinese children’s immunization program in 2002, its prevalence has dropped to the current rate of below 1 percent, Cui said.

Measles and meningococcal disease,which used to be common in children and adolescents, are now very rare, plummeting to historical low levels, he added.

Vaccination has played an important role in raising the life expectancy of Chinese citizens from 35 years old at the founding of the People’s Republic of China in 1949 to the current 77 years old, Cui said. This has been mainly achieved by lowering the mortality rate of children under five years old.

Vaccines are strategic and publicbenefiting products, said Yuan Jie, Director of the Office for Administrative Law with the Legislative Affairs Commission of the NPC Standing Committee. “Because of the extreme importance of vaccines and related work, it is necessary to make a law governing them,” she said. n

Copyedited by Rebeca Toledo

Comments to wanghairong@bjreview.com

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New law to better regulate vaccine industry By Wang Hairong:ABoosterShotOfLegislation论文
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