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。
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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。
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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. 
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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.
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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:
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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.
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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. 
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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。 
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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。
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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?
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