Urgent recall of more than 20,000 boxes of antidepressants
On February 19, the State Food and Drug Administration issued a notice requiring all operating and using units to immediately stop selling and using the flupentixol and melitrazine tablets produced by Hainan Yier Pharmaceutical Co., Ltd.
The incident originated at the end of 2015. During the inspection by the Food and Drug Administration, it was found that the company's flupentixol hydrochloride produced by the company and flupentixol tolmelizine tablets had hidden quality problems, and serious defects were also found during the production of its medicines. The problems checked include: the raw materials of the drug are fake, the solubility does not meet the quality standards, and the data is used selectively. However, some batches of melitrazine hydrochloride have been used in the production of formulations. At present, 17 batches of problem drugs are being recalled, of which 24553 boxes are on the way to recall.
China's self-developed vaccine for children's hand-foot-mouth disease goes on the market
Recently, the enterovirus 71 (EV71) inactivated vaccine (human diploid cells), a new class 1 drug for national preventive biological products independently developed and developed by the Institute of Medical Biology of the Chinese Academy of Medical Sciences, obtained the first batch of vaccines Qualification report, officially put into use in the market. The protection rate of the vaccine against any degree of hand, foot and mouth disease caused by EV71 is 97.3%, and the protection rate of prevention of severe hand, foot and mouth disease caused by EV71 is 100.0%.
EV71 is the main cause of severe foot and mouth disease and death, which can cause 80% of severe cases and 93% of deaths. Due to the lack of effective specific drugs for the treatment of the disease, vaccination has become a fundamental means of preventing and controlling its outbreak. The EV71 inactivated vaccine is made by inoculating enterovirus 71 FY-23K-B strain into human diploid cells, and after culture, virus harvest, inactivation and purification, it is made by adding aluminum hydroxide adjuvant and glycine stabilizer. This is the world's first EV71 vaccine, and it is also an EV71 vaccine product produced using a human-derived cell matrix.
Experts said that the successful use of the vaccine will effectively control the spread of HFMD in children, which will become an important milestone for humans to overcome HFMD in children.
16 drug companies have been involved in 16 vaccination agencies
In response to the case of Shandong Province, South Africa and South Africa, operating a vaccine case, in the afternoon of March 24, the State Food and Drug Administration, the State Health and Family Planning Commission and the Ministry of Public Security held a press conference. Li Guoqing, director of the Department of Pharmaceutical and Chemical Supervision of the State Food and Drug Administration, said that after the case occurred, the three departments established a joint working mechanism to carry out related work in accordance with their respective functions. As of that day, 41 people were found to be in line with the clues involved in the case, and 46 were down the line. There were 29 suspected drug dealers operating illegally and 16 vaccination agencies suspected of purchasing illegal vaccines.
According to the State Food and Drug Administration's data analysis on the seizure of drugs in the vaccine case of Shandong, South Africa and France, 9 drug wholesale companies are suspected of fictional vaccine sales channels, which may be the main responsible for causing the vaccines in the case to flow into illegal channels. The General Administration of Food and Drug Administration requires the relevant provincial Food and Drug Administration to immediately investigate the 9 companies involved in the case, thoroughly investigate the true flow of their fictitious sales products, and find out that there are violations of laws and regulations, and immediately file a case for investigation and punishment according to law.
医药健康—— Medicine and Health——
食药监总局、计生委联合发布 Jointly released by the Food and Drug Administration and the Family Planning Commission
《医疗器械临床试验质量管理规范》 "Good Medical Device Clinical Trial Quality Management Specification"
近日，国家食品药品监督管理总局、国家卫生和计划生育委员会联合发布《医疗器械临床试验质量管理规范》。 Recently, the State Food and Drug Administration and the National Health and Family Planning Commission jointly issued the "Code for the Quality Management of Medical Device Clinical Trials." 《规范》共 11 章 96 条，包括总则、临床试验前准备、受试者权益保障、临床试验方案、伦理委员会职责、申办者职责、临床试验机构和研究者职责、记录与报告、试验用医疗器械管理、基本文件管理、附则。 There are 11 chapters and 96 articles in the "Specifications" , including general rules, preparation before clinical trials, protection of the rights and interests of subjects, clinical trial protocols, duties of ethics committees, duties of sponsors, duties of clinical trial institutions and researchers, records and reports, and medical treatment for trials. Device management, basic document management, supplementary rules. 《规范》将于 2016 年 6 月 1 日起施行。 The Code will come into effect on June 1 , 2016.
通过临床试验获得有效数据是评价医疗器械是否安全有效的重要方式之一。 Obtaining valid data through clinical trials is one of the important ways to evaluate the safety and effectiveness of medical devices. 《规范》重点在以下几个方面，规范医疗器械临床试验行为，保证临床试验结果的真实、可靠、准确、科学和完整：一是明确临床试验申办者、临床试验机构和研究者，以及临床试验的监管部门等各方职责，强调申办者对临床试验的管理责任、细化临床试验机构和研究者的责任和义务要求；二是加强对受试者权益的保护，完善相关管理制度和要求，突出伦理委员会的作用和受试者知情同意，明确要求申办者对发生与试验相关的伤害或者死亡的受试者承担治疗的费用及相应的经济补偿；三是严格临床试验风险管理，强调临床试验全过程的风险控制，明确临床试验的暂停和终止机制，落实申办者的主体责任，保证临床试验过程的安全和可控。 The "Specification" focuses on the following aspects to regulate the behavior of clinical trials of medical devices to ensure the authenticity, reliability, accuracy, science and integrity of clinical trial results: First, to clarify the sponsors of clinical trials, clinical trial institutions and researchers, and clinical trials The responsibilities of the supervisory authority and other parties emphasized the sponsor's management responsibility for clinical trials, detailed the responsibilities and obligations of clinical trial institutions and researchers; the second is to strengthen the protection of the rights and interests of subjects and improve relevant management systems and requirements. Highlight the role of the ethics committee and the informed consent of the subjects, and explicitly require the sponsor to bear the cost of treatment and corresponding economic compensation for the subjects who have suffered injury or death related to the trial; the third is strict clinical trial risk management, emphasizing clinical trials Risk control throughout the process, clarifying the mechanism of suspension and termination of clinical trials, implementing the main responsibility of the sponsor, and ensuring the safety and controllability of the clinical trial process.
食药监总局 Food and Drug Administration
公开征求药品经营质量管理规范修订的意见 Public Solicitation of Opinions on the Revision of Goods Management Standards for Pharmaceutical Business
近日，食品药品监督总局为强化企业主体责任，建设来源可查、去向可追、责任可究的药品追溯体系，在听取部分药品生产企业、药品经营企业、相关行业协会以及专家意见的基础上，起草了《药品经营质量管理规范》（修订草案），并向社会公开征求意见。 Recently, in order to strengthen the corporate responsibility, the Food and Drug Administration has established a drug traceability system with traceable sources, traceable sources, and accountable responsibilities. Based on the opinions of some drug manufacturers, drug distributors, relevant industry associations, and experts, Drafted the "Good Manufacturing Practices for Drugs" (Revised Draft) and solicited opinions from the public.
食药监总局 Food and Drug Administration
公开征求保健食品原料目录 Public Request for Catalogue of Health Food Ingredients
按照新修订的食品安全法的相关要求，为规范保健食品原料目录管理，依法开展保健食品备案管理工作，国家食品药品监督管理总局组织起草了保健食品原料目录（第一批）——保健食品中营养素补充剂原料目录（征求意见稿），并向社会公开征求意见。 In accordance with the relevant requirements of the newly revised Food Safety Law, in order to regulate the management of health food ingredient catalogs and carry out the management of health food filings in accordance with the law, the State Food and Drug Administration has drafted the health food ingredients catalog (the first batch)- List of raw materials for nutrient supplements (draft for comments), and openly solicit opinions from the public.
人民银行联合多部门发文 The People's Bank of China issued a joint multi-sector document
助推养老服务业快速发展 Boost the rapid development of the elderly service industry
月 21 日 March 21 ，人民银行、民政部、银监会、证监会、保监会等部门联合印发的《关于金融支持养老服务业加快发展的指导意见》要求，金融业优化业务布局，大力推动组织、产品和服务创新，提升居民养老财富储备和养老服务支付能力，实现支持养老服务业和自身转型发展的良性互动。 , The People's Bank of China, the Ministry of Civil Affairs, the China Banking Regulatory Commission, the China Securities Regulatory Commission, the China Insurance Regulatory Commission and other departments issued a "Guiding Opinions on the Financial Support of the Accelerated Development of the Elderly Service Industry", which requires the financial industry to optimize its business layout, vigorously promote organizational, product and service innovation, and improve residents The old-age wealth reserve and the ability to pay for old-age services realize the positive interactions that support the old-age service industry and its transformation and development.
《意见》提出，要积极创新专业金融组织形式，探索建立养老金融事业部制、组建多种形式的金融服务专营机构，创新适合养老服务业特点的贷款方式，探索拓宽养老服务业贷款抵押担保范围，加大对养老领域的信贷支持力度。 The "Opinions" proposes that we should actively innovate professional financial organization forms, explore the establishment of an endowment financial department system, set up various forms of financial service franchise institutions, innovate loan methods suitable for the characteristics of the endowment service industry, and explore and expand the scope of endowment service loan mortgage guarantees. , Increase credit support for the elderly.
在拓宽融资渠道方面，《意见》提出，推动符合条件的养老服务企业上市融资，支持不同类型和发展阶段的养老服务企业、项目通过债券市场融资，完善养老保险体系建设，为养老服务企业及项目提供中长期、低成本资金支持。 In terms of broadening financing channels, the Opinions propose to promote the listing and financing of eligible pension service companies, support different types and development stages of pension service companies and projects, use the bond market to finance, and improve the construction of the pension insurance system for pension service companies and projects. Provide medium and long-term, low-cost funding support.
在提高居民养老领域的金融服务能力和水平方面，《意见》提出要优化网点布局，增强老年群体金融服务便利性，积极开发可提供长期稳定收益、符合养老跨生命周期需求的差异化金融产品。 In terms of improving the financial service capacity and level of the elderly in the field of elderly care, the Opinions propose to optimize the layout of outlets, enhance the convenience of financial services for the elderly, and actively develop differentiated financial products that can provide long-term stable income and meet the needs of the elderly across the life cycle.
《意见》明确，建立人民银行、民政、金融监管等部门参加的金融支持养老服务业工作协调机制，加强产业政策与金融政策协调配合，综合运用多种金融政策工具，加强政策落实与效果监测，形成推进养老服务业发展的政策合力。 The Opinions clearly established the establishment of a coordination mechanism for financial support for the elderly service industry with the participation of the People's Bank of China, civil affairs, financial supervision and other departments, strengthening the coordination and coordination of industrial policies and financial policies, comprehensive use of various financial policy tools, and strengthening of policy implementation and effectiveness monitoring. Form a policy synergy to promote the development of the elderly service industry.
新药不新现象严重 New drugs are not new phenomenon is serious
多家药企研发费用投入低 Low investment in R & D of many pharmaceutical companies
随着上市公司 2015 年年报的披露，截至今年 2 月 16 日，总计有 7 家药企披露了研发费用总额及研发费用总额占其去年营业收入的比重。 With the disclosure of the 2015 annual reports of listed companies , as of February 16 , this year , a total of 7 pharmaceutical companies disclosed the total R & D expenses and the total R & D expenses as a percentage of their operating income last year. 其中哈药股份的医药研发费用高，不过，仅占其去年营业收入的比例的 1.27% ；花园生物 2015 年的研发费用占营业收入比例为 9.5% ，但其去年的研发费用总额仅为 1438 万元。 Among them, the pharmaceutical research and development expenses of Harbin Pharmaceutical are high, but only accounted for 1.27% of its operating income last year ; the research and development expenses of Garden Bio in 2015 accounted for 9.5% of its operating income , but its total research and development expenses last year were only 14.38 million yuan. 其余企业也是如此，多家药企研发费用投入占比还不足 1% 。 The same is true of the rest of the companies, and the R & D expenditure of many pharmaceutical companies accounts for less than 1% .
在国家大力推进医药产业创新升级时，提升药企的研发能力也是重要环节之一。 When the country vigorously promotes the innovation and upgrading of the pharmaceutical industry, improving the R & D capabilities of pharmaceutical companies is also one of the important links. 国务院也在会议上提出加强原研药、首仿药、中药、新型制剂、高端器械的研发创新，以及肿瘤、糖尿病、心脑血管疾病等多发病和罕见病药物的产业化。 At the meeting, the State Council also proposed to strengthen the research and development of original research drugs, first generic drugs, traditional Chinese medicine, new preparations, high-end devices, and the industrialization of frequently-occurring and rare diseases such as tumors, diabetes, and cardiovascular and cerebrovascular diseases. 还提及结合医疗、医保、医药联动改革，加快临床急需药物和医疗器械产品审评审批，以提升企业加大研发投入的积极性。 It also mentioned the combination of medical, medical insurance, and medical linkage reforms to speed up the review and approval of clinically urgently needed drugs and medical device products to increase the enthusiasm of enterprises to increase investment in research and development.
破解“儿童用药难” Cracking the "difficult drug for children"
两会代表建议：鼓励药企优先生产儿童药 Representatives of the two conferences recommend that pharmaceutical companies be encouraged to give priority to the production of children's medicines
月份召开的全国两会上，如何破解“儿童用药难”引发两会代表委员热议，儿童用药的研发一直存在较大的空白。 At the National Two Conferences held in March , how to solve the "difficulty of children's medication" caused hot debate among the members of the two conferences. There has been a large gap in the development of children's medication. 国家卫计委全国合理用药监测系统专家孙忠实指出，国内儿童专用药数量太少，目前常见的处理方法是把儿童看成是“缩小的成人”，即依据儿童的年龄、体重、体表面积等，按照一定的比例将成人用药“折算”出儿童的用量。 Sun Zhongshi, an expert of the National Drug Administration Monitoring System for National Health and Family Planning Commission, pointed out that there are too few domestic children's special medicines. At present, the common treatment method is to treat children as "reduced adults", that is, based on children's age, weight, body surface area, etc. According to a certain ratio, the adult drug is "converted" to the child's dosage.
为了解决好儿科用药的保障问题，卫计委将会同食药、工信等部门，采取加快建立儿童药申报审批专门通道，招标定点生产儿童用药，鼓励优先生产，强化质量安全监管，指导合理用药这些综合措施，来保障儿童用药。 In order to solve the problem of guaranteeing pediatric medications, the Health and Family Planning Commission will work with the Food and Drug Administration and the Industrial and Information Department to accelerate the establishment of a special channel for the declaration and approval of children's medicines, invite tenders to produce children's medicines, encourage priority production, strengthen quality and safety supervision, and guide rational use of medicines. These comprehensive measures to protect children's medication.
两会上，还有代表委员建议设立儿童用药专项研发基金，支持高校、科研机构、药企等成立专门的儿童药品研发实验室。 At the two conferences, some members suggested that special children's drug research and development funds be established to support universities, scientific research institutions, and pharmaceutical companies to set up special children's drug research and development laboratories. 同时，建立国家儿童基本药物目录，实现儿童用药的“医保全享有”和儿童药品的“医保畅通行”，通过制定儿童药品单独定价和税收减免政策，调动药企生产积极性。 At the same time, a national children's essential medicines catalogue has been established to achieve "full medical insurance enjoyment" of children's medicines and "medical insurance access" for children's medicines. Through the formulation of separate pricing for children's medicines and tax reduction and exemption policies, the enthusiasm of pharmaceutical companies for production is mobilized.