作者:郑辉  王业  张艺昕  金杜律师事务所

电影《我不是药神》中,印度制药企业仿制的抗癌药物药效与专利药不相上下,而价格却与专利药有天壤之别,从侧面反映了印度制药企业现在的仿制药研发和生产能力。 Continue Reading 《我不是药神》系列探讨丨印度制药行业监管法律政策介绍

作者:杨帆 张运帷 黄中斌  金杜律师事务所

自从2017年4月网传的《<关于征求互联网诊疗管理办法(试行)>(征求意见稿)》中略显惊悚的规定[1]给互联网医疗悬了一柄达摩克利斯之剑以后,监管走向的不确定性成为了这一行业最大的阴影。 Continue Reading 老树新芽,小荷尖角 ——您的好友“互联网医院”已正式上线

by Huang Jianwen 

With multiple authoritative statements drawing wide attention, Hainan’s pharmaceutical and healthcare industry is seeking comprehensive development

The year of 2018 is a remarkable year in Hainan’s pharmaceutical and healthcare industry. The mission of medial development is noted conspicuously in President Xi Jinping’s remarks celebrating the 30th anniversary of the founding of the Hainan Province and the Hainan Special Economic Zone, and the “Guiding Opinions of the CPC Central Committee and the State Council on Supporting Hainan in Comprehensively Deepening Reform and Opening-up” (“Guiding Opinions”). Furthermore, the “Decision of the State Council on Suspending the Implementation of the Regulations on the Supervision and Administration of Medical Devicesin the Boao Lecheng International Medical Tourism Pilot Zone, Hainan Province” (“Decision”), issued on April 2, has officially handed over to the Hainan Provincial Government the approval power associated with medical institutions’ using unregistered medical devices that are urgently needed for clinical use. Continue Reading Stay Focused on the Policies of Hainan’s Pharmaceutical and Healthcare Industry

作者:黄建雯   金杜律师事务所 商务合规部

  • 多项中央动态引发关注, 海南医药健康产业盼全面发展

 

2018年对于海南医药健康产业而言是意义非凡的一年。中共中央总书记习近平在庆祝海南建省办经济特区30周年大会上的讲话,以及《中共中央、国务院关于支持海南全面深化改革开放的指导意见》(“《指导意见》”)都对海南医药健康产业发展予以重点关注。不仅如此, 4月2日出台的《国务院关于在海南博鳌乐城国际医疗旅游先行区暂停实施<医疗器械监督管理条例>有关规定的决定》(“《决定》”)将医疗机构临床急需且在我国尚未注册的进口医疗器械事项上的审批权正式下放海南省政府。习总书记的讲话和《指导意见》中透露的顶层战略,以及《决定》所给予的分量十足的法律变通,都昭示着中央推进海南医药健康产业发展的决心和海南医药健康产业的巨大潜力。 Continue Reading 聚焦海南医药健康产业政策

作者:宋瑞秋 章程 金杜律师事务所公司业务部

总理发话,支持互联网医院

就在前两周,从李克强总理在华山医院考察远程会诊中心,到国务院常务会议审议原则通过《关于促进“互联网+医疗健康”发展的指导意见》,再到国家卫健委就《指导意见》进行说明,短短时间内,支持互联网医院发展的监管信号被明确释放。

互联网医院并不是一个新鲜概念,于2013年开始萌芽,并在2016年前后历经爆发式成长。随着近期高层不断释放积极信号,我们不禁期待:互联网医院又要来了! Continue Reading 互联网医院的小宇宙会再次爆发吗

 

作者:尹居全 刘婷 余瑞 金杜律师事务所商务合规部

2018年1月,《深圳经济特区食品安全监督条例》(以下称为“《条例》”)经深圳市第六届人民代表大会常务委员会第二十二次会议审议通过,予以公布,即将于2018年5月1日起施行。《条例》从“一审”到“三审”历时一年半,期间历经多次立法调研和修改,最终得以公布。《条例》对政府监督举措、食品生产经营者自我监督及社会监督等方面内容进行了明确。可以说,《条例》一经公布,标志着深圳食品安全领域的“深圳标准”的诞生。 Continue Reading 厉害了!为“深圳标准”点赞!——解读《深圳经济特区食品安全监督条例》

作者:陈兵 杨玥 金杜律师事务所公司证券部

自2008年奶制品三聚氰胺污染事件发生之后,近十年来,婴幼儿配方乳粉行业的监管体系持续发生着变革。婴幼儿配方乳粉产品配方注册制度可能是其中最为重要的一项变革,并将影响行业内的所有参与者。

自2018年1月1日起,新食品安全法中关于婴幼儿配方乳粉的配方注册制度开始全面执行。无论是在我国境内生产的还是通过一般贸易进口至我国的婴幼儿配方乳粉产品,在中国市场销售前都必须获得配方注册证书。这项要求将影响市场上数以千计的婴幼儿配方乳粉品牌,其中相当大的一部分将因为这一制度被淘汰出局。 Continue Reading 中国婴幼儿配方乳粉迎来新时代

By Chen Bing  and Yang Yue King & Wood Mallesons’ Corporate & Securities group

Since the melamine milk scandal in 2008, there has been constant reform to the supervision of the infant formula industry. Registration of infant formula milk powder (“Infant Formula”) is probably one of the most significant changes. It will greatly affect all the industry players.

From 1 January 2018, the Infant Formula registration requirements in the new Food Safety Law came fully into force. Infant Formula products, either domestically manufactured or imported through general trade, must obtain formula registration before they can be sold in the PRC. This requirement will impact thousands of Infant Formula brands in the market – a great portion of which will not survive this change.  Continue Reading New Era for Infant Formula in China

By Huang Jianwen King & Wood Mallesons’ Commercial & Regulatory group

In order to deepen the reform in the field of drugs, the China Food and Drug Administration (“CFDA”) issued the Drugs Administration Law (Draft for Consultation) (“Draft”) on 23 October 2017. The Draft incorporates and reflects material contents in the reform of drugs field in recent years, including fully implementing the Marketing Authorization Holder (“MAH”) system, cancelling certificates of Good Manufacturing Practice (“GMP”) and Good Supply Practice (“GSP”), carrying out records management for clinical trial institution and emphasizing legal liabilities on relevant entities in drug research and trial. Continue Reading Analysis on the Drugs Administration Law (Draft for Consultation)