Traditional Chinese medicine circle information optimization ~ focus on the industry hot things

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2017年5月4日,周四,农历四月初九,丁酉鸡年甲辰月辛卯日。

01CFDA印发保健食品备案产品可用辅料及使用规定、生产工艺、工作指南等试行通知
再谈信息安全意识推广计划
国产及进口保健食品备案人需提出获取备案管理信息系统登录账号的申请
5月2日,CFDA官网发布《保健食品备案产品可用辅料及其使用规定(试行)》《保健食品备案产品主要生产工艺(试行)》《保健食品备案工作指南(试行)》的通知。
试行工作指南指出,生产经营保健食品,国产保健食品备案人应向所在地省、自治区、直辖市食药监部门提出获取备案管理信息系统登录账号的申请;进口保健食品备案人申请备案系统登录账号时,需携带产品生产国(地区)政府主管部门或法律服务机构出具的备案人为上市保健食品境外生产厂商的资质证明文件和联系人授权委托书等;原注册人产品转备案的,应当向总局技术审评机构提出申请。
备案材料项目包括保健食品备案登记表和法律责任承诺书、备案人主体登记证明文件、产品配方材料、产品生产工艺材料、安全性和保健功能评价材料等7项内容。
此次备案产品主要生产工艺适用于补充维生素、矿物质等营养物质的保健食品(营养素补充剂),分为片剂、硬胶囊、软胶囊、口服液、颗粒等。
辅料使用规定要求,辅料不得对人体产生任何健康危害;不以掩盖产品腐败变质为目的;不以掩盖产品本身或加工过程中的质量缺陷或以掺杂、掺假、伪造为目的;不降低产品本身的保健功能和营养价值;在达到预期效果的前提下尽可能降低在产品中的使用量;加工助剂的使用应符合《食品安全国家标准食品添加剂使用标准》。
02上海市市场监管体制改革,药监局或将撤销?
信任建立在互相了解和尊重的基础上,所以要遵守当地的法律法规,要了解当地的游戏规则和适应当地的文化。国内的安全业者要走向全球,首先要在企业内建立全球标准的遵循文化。
赛柏蓝分析称将掀起食品药品监管模式改变风暴
据知名公号赛柏蓝报道,近日有消息称上海市委同意”设立中共上海市市场监督管理工作委员会”,负责上海市工商行政管理局、质量技术监督局、食品药品监督管理局等部门党的工作;同时撤销上海市质量技术监督局委员会、中共上海市食品药品监督管理局委员会等。人民日报曾发表观点认为,食品安全监管是典型的九龙治水,工商、质监、食药三部门在监管实践中往往职能交叉、衔接不畅、相互推诿,出现”缺位”弊端。而大市场大部门监管体制改革的尝试,是转变政府职能、进一步简政放权的探索。
结合2014年7月天津市将工商、食药监、质监三部门”三合一”成立市场和质监委员会,以及更早前深圳特区、上海浦东新区、浙江舟山等地建立市场监管局的探索先例,赛柏蓝认为,上海市”三合一”的举措,很可能会把这一模式在直辖市试行后向全国推广,”毫无疑问的是,全国食品药品监管模式的改变,将真正掀起一次大风暴”。
优选简讯
医务人员注册明年全部电子化。国家卫计委与国家中医药管理局日前联合印发《关于加快医疗机构、医师、护士电子化注册管理改革的指导意见》,要求到2018年6月,全面实施电子化注册管理,覆盖全国所有医疗机构、医师、护士;到2020年,基本完成电子证照的发放使用工作。根据进度安排,到2017年6月,各省份启动电子化注册管理改革试点;到2017年12月,各省份40%以上的地市开展电子化注册管理改革。

《自然-生物技术》:获得韩春雨实验可重复性新数据

四川全省开展中药提取物专项检查。四川省食药监局日前发布公告,在全省开展为期6个月的中药提取物生产使用专项检查。检查范围为:涉及中药提取物的中成药生产企业,重点对集团内共用、企业异地设立、外省企业在四川省设立前处理及提取车间开展专项检查,督促企业严格按照GMP要求进行生产;检查重点包括提取能力、工艺和处方、投料规范、批准程序、工艺参数等18项内容。北京同仁堂、太极集团、康美药业旗下公司等28家中药企是此次检查的重点对象。
1004种药品或被踢出广东市场。5月2日,广东省药品交易中心发布公示,1004种不供货或者供货不及时的药品在公示10天内(截至5月12日17时)仍不能及时供货的,根据相关规定将被踢出广东医疗市场2年;配送不及时的药商,取消2年配送资格。本次公示涉及药企135家,包括白云山、神威等中药名企。
安徽食药监局拟确定中药配方颗粒试点研究单位。5月2日,安徽省食药监局对安徽省中药配方颗粒试点研究单位进行为期7天的公示,拟确定单位6家,分别是:安徽华润金蟾药业股份有限公司、安徽济人药业有限公司、安徽九州方圆制药有限公司、华佗国药股份有限公司、安徽广印堂中药股份有限公司、安徽协和成制药有限公司。
《中医药真实世界临床研究技术规范》等3项团体标准立项。5月2日,中华中医药学会发布公告,批准《中医药真实世界临床研究技术规范》、《中国成年人中医体质调理指南》、《癌毒病机理论辨治恶性肿瘤临床指南》等3项团体标准立项。
中国中医师首获澳洲中医立法范围内执业准证。据北京中医药大学官网消息,近日,北京中医药大学派往”澳大利亚中医中心”的中国中医执业医生首次获得澳大利亚官方管理机构AHPRA颁发的”中医师-中医针灸师-中药师执业准证”。这是澳洲官方管理机构第一次评审中国医生以教育与科研为目的、可以从事中医临床的职业准证申请。
中医药文化走进河北衡水中学。日前,国家中医药管理局对台港澳中医药交流合作中心为河北衡水中学高一A部学生作题为”健康靠自己——中医药文化与养生健康”的报告。报告会从健康标准和发病原因、中医文化、中医养生之道三个方面,详细阐述了天人合一的整体观、阴阳五行的动态观、三因制宜的辨证观等中医文化,以及中医针灸的相关知识和国内外发展趋势,让学生充分认识了解中医文化,感受传统文化的魅力。
名企动向
蒿甲醚原料药通过世卫组织PQ认证。5月2日,昆药集团发布公告称,旗下全资子公司华武制药收到世界卫生组织关于蒿甲醚原料药的PQ(生产预认证)确认函,相关产品已被列入世卫组织的推荐采购清单。这是华武制药继双氢青蒿素原料药后,又一个走上面向全球采购平台的PQ认证品种。
20家上市中药企2016年毛利率超70%。根据上市公司年报,截至4月28日,共有20家中药企上市公司2016年毛利率在70%以上。毛利率超过80%的药企共5家,分别是:康弘药业(90.41%)、济川药业(85.24%)、奇正藏药(84.51%)、步长制药(83.17%)、上海凯宝(81.25%)。
美通社:龙发制药成中国彝药第一股。据中国制药网转载美通社文章,以生产云南名牌产品”维C银翘片”、”陈香露白露片”知名的药企云南龙发制药日前在新三板挂牌入市,成为中国彝药第一股。董事长焦家良介绍,龙发制药将充分借力资本市场,推动中国彝药”理论市场、产品市场”建设,在医药、保健等领域打造大健康生态产业链,深耕彝药健康产业。资料显示,龙发制药始建于1967年,原名楚雄州制药厂,1998年改制为有限责任公司;2003年被香港龙发制药集团收购,同时更名为云南龙发制药有限公司。
天圣制药IPO获证监会核准。天圣制药5月2日发布公告,其上市申请已获得证监会核准,将于本月10日首次公开发行不超过5300万股A股,募集资金将投向口服固体制剂GMP技术改造、非PVC软袋大容量注射剂GMP技术改造、天圣(重庆)现代医药物流总部基地和药物研发中心建设等4个项目。天圣制药目前有77种药品进入国家基本药物目录、152种药品被列入国家医保目录,拥有“延参健胃胶囊”和“地贞颗粒”两个独家品种。据媒体预计,从A股同等营收体量的公司以及市盈率看,天圣制药上市后市值或达百亿。
医药电商握手:”找药材”与”药便宜”战略合作。近日,医药B2B平台“药便宜”与中药材B2B平台“找药材”在北京签署战略合作协议。通过合作,“找药材”可从“药便宜”获得相应的商家店铺服务和便宜贷金融服务等,同时也为其用户提供更多分销渠道;“药便宜”则可通过“找药材”完善其“中药材、中药饮片和中成药”的板块品类。
药事舆情
3家药企生产销售劣药/假药银杏叶片。CFDA官网5月2日公布3家药企生产销售劣药/假药银杏叶片案行政处罚信息。信息显示,宁波立华制药生产的63批次银杏叶片经检查为劣药,湖北午时药业和黑龙江天宏药业生产的共25批次银杏叶片均被依法定性为假药。根据《药品管理法》规定,3家公司的“银杏叶片批准证明文件”被撤销。
飞检不合格,两企业被收回GMP证书。CFDA官网5月2日发布飞行检查通报,河南省康华药业、江苏平光信谊(焦作)中药两家公司因严重违规分别被收回GMP证书,并被立案查处。通报显示,康华药业企业物料、生产和文件管理混乱,中药饮片前处理生产操作未按照《藿香正气丸工艺规程》组织生产;平光信谊(焦作)部分藿香正气丸中药材前处理和制剂批生产记录不真实,物料管理、质量控制和质量保证等环节不能有效执行药品GMP规范要求,并存在设备不能满足炮制规范要求等诸多问题。
辽宁全省暂停销售5种药品。5月2日,辽宁省药监局发布通知,对严重违规宣传的5种中药产品在辽宁全省暂停销售。涉事企业及产品为:哈尔滨亲情制药生产的”仙灵地黄补肾颗粒”(辽宁电视台生活频道及影视剧频道,播出95次)、长春新安药业生产的”喘咳宁片”(辽宁电视台生活频道,播出15次)、昆明全新生物制药生产的”玄驹胶囊”(辽宁电视台生活频道,播出14次)、辽宁澎健药业生产的”罗黄降压片”(大连晚报、新商报,印发5次)、河南百年康鑫药业生产的”归元健脑片”(晚晴报,印发1次)。

深圳证券市场17年5月2日创业板交易公开信息

38批次不合格药品被查处,涉36批次中药。日前,山西省药监局发布药品质量公告,通过对全省范围内的药品生产、经营企业和医疗机构进行抽查检验,共发现38批次药品不符合规定,其中有21批次为”非该企业生产”或”该企业未生产过”。在38批次药品中,涉及中药产品醋没药12批次、没药11批次、红花10批次,枳实、白鲜皮、菟丝子各1批次。
优选活动【博览会】2017年8月4日-6日,中华中医药学会主办2017中国(北京)国际中医药健康服务博览会暨首届中医药健康服务业发展论坛。地址:中国国际展览中心;联系人及电话:万鑫010-6556 7337。
【文化周】2017年10月21日-22日,世中联主办第十四届世界中医药大会暨”一带一路”中医药文化周。地址:泰国曼谷;联系人及电话:邹建华 010-5865 0042/5865 0243。
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The public number sponsored by the China Association of traditional Chinese medicine information Specialized Committee, please click on the top of the circle of traditional Chinese medicine concern us.
May 4, 2017, Thursday, the 9th day of the fourth month of the Chinese lunar calendar, the year of the rooster – Chen jeongyujaeran nationalist revolution.
01CFDA printing and health care products for the record of available materials and the use of the provisions of the production process, work guide and other trial notice
Domestic and imported health food for the record to obtain access to the record management information system login account application
In May 2nd, CFDA released the official website of the provisions of the available materials and their use of health food products for the record (Trial) health food products for the main production process (Trial) health food filing guidelines (Trial) notice.
The pilot work guide pointed out that the production and management of health food, domestic health food should record to the location of provinces, autonomous regions and municipalities directly under the food and drug administration department proposed to obtain account record management information system login application; imported health food for record filing system login account, need to carry the producing country (region) issued by the competent government for the record department or legal services for overseas listed health food manufacturers qualification documents and contact authorization; the original registered product transfer record, shall apply to the administration of the technical review mechanism to apply.
The archival materials include health food registration form and legal liability undertaking, filing registration certificate, main product formulation materials, production process, material safety and health function evaluation materials and other 7 items.
The main products for the production process is applied to supplement vitamins, minerals and other nutrients of health food (nutritional supplements), divided into tablets, hard capsules, soft capsules, oral liquid, particles, etc..

宋新能源目前价格稳定 售价21.59万元起广告

The use of material requirements, materials shall not have any health hazards to the human body; not to conceal the products’spoilage for the purpose; not to conceal the quality defects of the product itself or processing or adulterate, forged for the purpose; the product itself does not reduce the health function and nutritional value; on the premise of achieving the desired results as may reduce the amount of the product in use; processing aids should be consistent with the standards for use of food safety standards of food additives.
02 Shanghai market regulatory reform, the food and Drug Administration or will be withdrawn?
Saibai blue analysis will set off the food and drug administration to change the mode of the storm
According to well-known public, Saibai blue reports, the recent news that the Shanghai municipal Party committee agreed that the establishment of the CPC Shanghai municipal market supervision and Management Committee, responsible for the Shanghai City Administration of Industrial and Commercial Bureau, bureau of quality and technical supervision, food and Drug Administration and other departments of the work of the party; at the same time cancel the Shanghai Municipal Bureau of quality and technical supervision, Shanghai Committee of CPC the food and Drug Administration committee. People’s Daily has published view, food safety supervision is typical of the Kowloon flood, industry and commerce, quality supervision, food and drug supervision departments in the three practice often overlapping functions, poor convergence, mutual shuffle, Absence defects. The big market regulatory reform attempt is to explore the transformation of government functions, further decentralization.
Tianjin city in July 2014 with the industry and commerce, food and drug administration, quality supervision departments of the three three in one established market and Quality Supervision Committee, and even earlier, Shanghai District of Shenzhen Pudong New Area, Zhejiang Zhoushan and the establishment of market supervision bureau of exploration of precedent, Saibai blue believes that the three in one in the city of Shanghai is likely to move the model in the municipalities directly under the central government after the implementation of promotion to the nation, there is no doubt that the national food and drug supervision mode change, will really set off a big storm.
Preferred SMS
Medical staff registration next year all electronic. The State Planning Commission and the State Administration of traditional Chinese medicine jointly issued on the day before the medical institutions, doctors and nurses electronic registration management reform guidance requirement, by June 2018, the full implementation of electronic registration management, covering all the medical institutions, doctors and nurses; by 2020, the basic completion of the use of electronic license issuing work. According to the schedule, by June 2017, the province started the electronic registration management reform pilot; by December 2017, more than 40% of the provinces and municipalities to carry out electronic registration management reform.
Sichuan province to carry out special inspection of traditional Chinese medicine extract. Sichuan provincial food and drug administration before the announcement, in the 6 months to carry out a special inspection of the use of Chinese herbal extract production. Check range: to extract of traditional Chinese medicine Chinese medicine production enterprises, focus on the group’s share, enterprise establishment, provincial enterprises set up pretreatment and extraction workshop in Sichuan province to carry out special inspection, and urge enterprises to carry out production in strict accordance with the GMP requirements; check the key ability, including the extraction process and formulation, feeding, approval procedures, process specification the contents of 18 parameters. Beijing Tongrentang, Tai Chi Group, the United States and China Pharmaceutical Co., Ltd. and other 28 companies are the focus of the inspection object.
1004 drugs or kicked out of Guangdong market. In May 2nd, the drug trade center in Guangdong Province issued publicity, the 1004 do not supply or not timely supply of medicines in the public within 10 days (as of May 12th 17) is still not timely delivery, according to the relevant provisions will be kicked out of the medical market in Guangdong for 2 years; the drug delivery is not timely, cancel 2 years distribution qualification. This publicity involves 135 pharmaceutical companies, including Baiyun Mountain, and other famous enterprises of traditional Chinese medicine.
Anhui food and drug administration intends to determine the pilot units of traditional Chinese medicine formula particles. In May 2nd, the Anhui provincial food and Drug Administration for 7 days of publicity in Anhui Province Chinese medicine granule pilot study to determine the unit, unit 6, namely: Anhui Huarun Limited by Share Ltd, Jinchan pharmaceutical Anhui Jiren Pharmaceutical Company Limited, Anhui Jiuzhou Fangyuan Pharmaceutical Co. Ltd., Limited by Share Ltd, Anhui Hua Tuo Chinese medicine Chinese medicine Limited by Share Ltd, glabellum Anhui unicooperate Pharmaceutical Co. ltd..
Chinese medicine real world clinical research technical specifications and other 3 groups of standard project. In May 2nd, the Chinese Medical Association issued a notice, approved by the Chinese medicine clinical research on real world technology standard, Chinese medicine physical conditioning, guide cancer pathogenesis theory of treating tumor clinical guide 3 group standard project.
Chinese medicine practitioners in Australia for the first time in the scope of legislation of Chinese medicine practitioners. According to the official website of Beijing University of Chinese Medicine news, recently, Beijing University of Chinese Medicine sent to Australia Chinese medicine center China TCM practitioners for the first time the Australian authorities issued the AHPRA Chinese Medicine – Chinese medicine and acupuncture – Chinese medicine practitioners permit. This is the first official review of the Australian government for the purpose of education and scientific research in China, can be engaged in the clinical application of Chinese medicine professional license.
Chinese medicine culture into Hebei Hengshui middle school. Recently, the State Administration of traditional Chinese medicine of traditional Chinese medicine in Hong Kong and Macao Cooperation Center for the Hebei Hengshui high school students A entitled health on their own — the culture of Chinese medicine and health report. The three report from the health standards and the cause of disease, traditional Chinese culture, traditional Chinese medicine describes a way of keeping good health, dynamic harmony between man and nature, the concept of yin and Yang and the five elements and three factors of the dialectical view of Chinese culture, and Chinese medicine acupuncture related knowledge and the domestic and foreign development trend, to enable students to fully understand Chinese medicine culture, feel the charm of traditional culture.
Trend of famous enterprises
Artemether raw material through the who PQ certification. In May 2nd, Kunming Pharmaceutical Group announced that a wholly-owned subsidiary of China Pharmaceutical WHO Wu received artemether on API PQ (production pre authentication) confirmation, related products have been included in the World Health Organization recommends purchasing list. This is the Chinese pharmaceutical pharmaceutical after the dihydroartemisinin dihydroartemisinin, and then go to a global procurement platform for PQ certification varieties.
20 listed Chinese enterprises in 2016 gross margin over 70%. According to the annual report of listed companies, as of April 28th, a total of 20 Chinese enterprises listed companies in 2016 gross margin of more than 70%. The gross profit margin of over 80% pharmaceutical companies a total of 5, namely: Kanghong Pharmaceutical (90.41%), jumpcan (85.24%), (84.51%), Qizheng Tibetan medicine (83.17%), Shanghai step pharmaceutical Kaibao (81.25%).
PR Newswire: first Chinese Yi medicine Longfa pharmaceutical stocks. According to the China pharmaceutical net reprint Newswire articles, in the production of brand-name products in Yunnan vitamin C Yinqiao Tablets and Chen Xianglu dew piece well-known pharmaceutical companies in Yunnan Longfa pharmaceutical before the date listed on the new board into the city, becoming the first Chinese Yi medicine shares. Chairman Jiao Jialiang introduction, Longfa pharmaceutical will fully leveraging the capital market, promote the China Yi medicine theory of construction market, product market, build healthy eco industrial chain in the field of medicine, health care, deep Yi medicine health industry. Statistics show that Longfa pharmaceutical was founded in 1967, formerly known as Chuxiong pharmaceutical factory, 1998 for the restructuring of the limited liability company; 2003 was acquired by Hongkong Longfa Pharmaceutical Group, and renamed Yunnan Longfa Pharmaceutical Co Ltd.
Tiansheng pharmaceutical IPO approved by the commission. Tian Sheng pharmaceutical May 2nd announcement, the listing application has been approved by the Commission, will not exceed 53 million shares of A 10 this month, the initial public offering, to raise funds to invest in technological transformation, oral solid preparation GMP non PVC soft bag large volume injection GMP technology, Tian Sheng (Chongqing) 4 projects of modern pharmaceutical logistics headquarters the base and the drug R & D center construction etc.. Tiansheng pharmaceutical currently has 77 kinds of drugs into the national essential drugs list, 152 kinds of drugs were included in the national health insurance directory, has two exclusive varieties yanshenjian capsule and Di Zhen granule. According to the media is expected from the same company A shares of sales volume and price earnings ratio, Tiansheng pharmaceutical market capitalization or 10 billion.
Pharmaceutical electricity supplier to shake hands: looking for herbs and medicine cheap strategic cooperation. Recently, the pharmaceutical B2B platform cheap medicine and Chinese herbal medicine B2B platform to find drugs in Beijing signed a strategic cooperation agreement. Through cooperation, looking for drugs can get the corresponding business shop service and cheap loans from financial services medicine cheap, but also for the user to provide more distribution channels; cheap medicine can find the perfect ingredients for Chinese traditional medicine and Chinese medicine category plate.
Pharmaceutical public opinion
3 companies in production and sales of counterfeit drugs \/ Ginkgo Biloba Leaves Extract Tablets. CFDA’s official website announced in May 2nd 3 companies production information administrative punishment \/ counterfeit drugs sales Ginkgo Biloba Leaves Extract Tablets case. Information display, Ningbo liwah pharmaceutical production of 63 batches of substandard drugs through inspection for Ginkgo Biloba Leaves Extract Tablets, Hubei Wushi pharmaceuticals and Heilongjiang Tianhong pharmaceutical production of a total of 25 batches of Ginkgo Biloba Leaves Extract Tablets were in accordance with the law for qualitative fake. According to the Drug Administration Law stipulates that the 3 companies, Ginkgo Biloba Leaves Extract Tablets approval documents were revoked.
Flight inspection failed, two companies were recovered GMP certificate. CFDA’s official website released May 2nd flight inspection bulletin, Henan Province, Jiangsu Hong Wah pharmaceutical Pingguang Xinyi (Jiaozuo) Chinese companies were withdrawn due to serious violations of the GMP certificate, and was punished. Bulletin shows, Hong Wah pharmaceutical enterprise material, production and file management, Chinese herbal medicine treatment before operation is not in accordance with the production process Huoxiangzhengqi pills; matt Xinyi (Jiaozuo) part of Huoxiangzhengqi pills pretreatment of traditional Chinese medicinal materials and preparation of the batch production record is not real, material management, quality control and quality assurance etc. can the effective implementation of drug GMP requirements, and there are many problems in processing equipment can not meet the specification requirements.
Liaoning province suspended the sale of 5 drugs. May 2nd, the Liaoning provincial food and Drug Administration issued a notice on the 5 kinds of serious violations of Chinese medicine products in Liaoning province to suspend sales. Someone’s business and products: Harbin family pharmaceutical production Xianling Dihuang Bushen Granule (Liaoning TV channel and television channel, broadcast 95 times), CHUANKENING tablets Changchun Xin’an pharmaceutical production (Liaoning TV channel, broadcast 15 times), the new Kunming Xuanju capsule bio pharmaceutical production (Liaoning TV channel broadcast, 14), Luo Huang tablets Liaoning PENGJian pharmaceutical production (Dalian evening news, new business, issued 5 times), Guiyuan Jiannao tablet Henan Kang Xin pharmaceutical production hundred years (evening newspaper, issued 1 times).
38 batches of substandard drugs were investigated, involving 36 batches of Chinese medicine. The day before, Shanxi province food and Drug Administration released drug quality announcement, make a random inspection by the province within the scope of the pharmaceutical production and operation enterprises and medical institutions, 38 batches of the drug is not in conformity with the provisions were found, including 21 batches of the non production or the enterprise production. In the 38 batch of drugs, traditional Chinese medicine products involving 12 batches of vinegar myrrh and myrrh 11 batches, 10 batches of safflower, Fructus aurantii Immaturus, dittany bark, dodder 1 batches.
-6 (August 4, 2017), the Chinese Academy of traditional Chinese medicine (TCM) hosted the 2017 China (Beijing) International Health Expo of traditional Chinese medicine and the first Forum on the development of traditional Chinese medicine health services. Address: China International Exhibition Center, contact person and telephone: Wan Xin 010-6556 7337.
[culture] week on October 21, 2017 -22, a World Federation hosted the Fourteenth World Congress of Chinese medicine and Chinese Medicine Culture Week area. Address: Thailand, Bangkok, contact person and telephone: Zou Jianhua 010-5865 0042\/5865 0243.
Long by two-dimensional code to me transfer
Affected by the new regulations of Apple Corp, WeChat iOS version of the feature is closed, can be transferred through the two-dimensional code to support public numbers.
WeChat sweep attention to the public number

多家银行的客户遭遇银行借记卡存款“不翼而飞”事件,猜想黑客盗银行卡和密码的技术又有了新的突破。

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