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)

By Shi Bisheng, Guan Xiangyu,King & Wood Mallesons’ IP group

In October 2017, the China Food and Drug Administration (“CFDA”) released a series of documents regarding reform of China’s drug administration system. The aim – more access to cutting-edge pharmaceuticals at a lower cost. This new patent linkage system (“PLS”) is discussed in the following two important documents: Continue Reading How to Rise Up to Challenges under Accelerated Enforcement of Patent Linkage

作者:石必胜 关祥宇 金杜律师事务所知识产权部

2017年十月,中国中央机构以及药监部门(即国家食品药品监督管理局,以下简称“CFDA”)出台了一系列关于药品监管体制改革的文件。其中,为了使广大患者能够以更低廉的价格更便捷地获取前沿药品,在以下两份重要文件中讨论了新的专利链接制度: Continue Reading 如何应对中国专利链接制度加速推进的挑战

By Song Ruiqiu and Lou Xiaohan King & Wood Mallesons’ Finance & Capital Markets group.

Middle Huaihai Road in Shanghai is home to a stately piece of architecture a well-known foreign owned Shanghai Redleaf International Women & Children’s Hospital (“Redleaf”). Incorporated on 9 December 2011, Redleaf had been operating from Middle Huaihai Road for over four years. As a hospital with high-end positioning, excellent medical staff, luxurious facilities, and quality services, Redleaf had attracted clients from all over the world. However, on 31 August 2017, Redleaf made a sudden announcement that it would be relocating its services to a different location at the request of the government.[1] The move that followed, happened almost overnight and, no doubt, brought with it significant consequences for the hospital, and its staff and patients. Continue Reading Establishing Medical Facilities in China: Redleaf Case Study

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

On October 10 2017, the China Food and Drug Administration (“CFDA”) issued the Decisions Concerning the Adjustment of Imported Drug Registration (No. 35 Order by CFDA,Decisions). This implements the policy of encouraging new drug marketing following the earlier issuances of Opinions on Deepening the Reform of Evaluation and Approval System and Encouraging the Innovation of Drugs and Medical Devices by the General Office of the CPC Central Committee and the General Office of the State Council on October 8.  Continue Reading The reform of imported drugs registration encourages the marketing of new drugs in China

作者:黄建雯 金杜律师事务所商务合规部

2017年10月10日,国家食品药品监管总局(以下简称“总局”)公布了《关于调整进口药品注册管理有关事项的决定》(国家食品药品监督管理总局令第35号,以下简称“《决定》”),这是继10月8月中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》后,我国鼓励新药上市举措的具体落地。  Continue Reading 进口药品注册改革鼓励新药上市

作者:莫里斯 & 莱荔 & 麓伯

据《三联生活周刊》9月12日报道,2017年8月31日,在榆林一院绥德院区待产的马茸茸坠亡之前,她曾经先后在6个不同的场合提出希望进行剖宫产的想法。然而,不管是医院还是家属,都没有满足她的需求,而是继续让产妇自然分娩,最终间接导致了悲剧的发生。 Continue Reading 病人、医院、家属:谁能在《知情同意书》上签字?

作者:宋瑞秋 金欣 刘瑞清 金杜律师事务所金融资本部

近日,专注于医疗领域的资深投资人球球收到某微信公众号的推送:“《国家职业资格目录》落地!医疗卫生领域职业资格大范围取消!”深知医疗人员职业资格对医疗机构的重要性,球球赶紧向其专注于医疗卫生领域的律师朋友求证:医疗人员职业资格不再是医疗机构设立和运营的硬性要求了?这是不是医疗机构准入条件放宽的一次重大利好? Continue Reading 医疗人员职业资格取消?别被标题党忽悠了!

作者:宋瑞秋  楼笑含  金杜律师事务所金融资本部

在淮海中路有一处高大气派的建筑,知名外资医院上海红枫国际妇儿医院(以下简称“红枫医院”)便在此运营;上海红枫国际妇儿医院有限公司于2011年12月9日成立,医院落址于此也已超四年。作为一家定位高端的外资妇儿医院,红枫医院集结了一批非常优秀的医务人员,并提供了优质的服务、配以奢华硬件设施,慕名而来的各国孕产妇络绎不绝。然而,2017年8月31日,红枫医院突然发布公告,应政府要求,红枫医院整体服务需要进行平移。[1]于是,几乎在一夜之间,红枫医院不得不紧急搬离,“此地空余诊疗楼”;不难想象,这一突然的信息在红枫医院的医护人员和顾客中都造成了极大的冲击。 Continue Reading 规避风险陷阱,打通医疗机构设立的任督二脉

作者:张运帷 李凌碧 黄中斌​ 金杜律师事务所公司证券部

本文梳理了网络医院的主要业务模式,并简述了其可能面临的法律障碍。

近几年,“网络医院”(含“云医院”、“互联网医院”、“智慧医院”等类似概念,下同)实现了井喷式的发展。据公开数据显示,从2011年到2016年,有533家互联网医疗企业总计获得了33.21亿美元的投资,平均每家企业的融资额约为623万美元[1]。尤其在2015年下半年后,在《国务院关于积极推进“互联网+”行动的指导意见》、《国务院办公厅关于推进分级诊疗制度建设的指导意见》等一系列政策导向的刺激下,“网络医院”在2016年如雨后春笋般在全国各地生长壮大。 Continue Reading 网络医院,我有病你能看吗?