By Huang Jianwen King & Wood Mallesons’ Investment Group
Background
Since 2010, the State Council has issued a series of policy documents promoting development of the healthcare industry by encouraging the inflow of social capital. As a result, non-public medical institutions have grown rapidly and their level of service has gradually improved. In general, however,
与中国很多的法律法规的出台相似，2009年2月出台的《食品安全法》从一开始即承载着特定的背景和期望。2008年三聚氰胺事件给中国食品监管体系敲响了警钟，作为众多措施之一，《食品安全法》在事件发生后半年内迅速出台。实施了近四年后，食品安全法于2014年进入全面修订。历经三次审议，全国人大常委于今年4月24日颁布了新修订的《食品安全法》。如此短时间内对一部上位法律进行重大修订，反映了中国复杂食品安全状况，也凸显了中央政府强化食品监管的强烈意志。
作为食品安全领域的上位法，《食品安全法》全局性统领食品监管法律体系。对于该领域的各个主体，包括监管机构、中介机构、市场主体（包括食品生产者、销售方、运输方、和其他食品相关方），新法都将带来重大的影响。
Continue Reading 企业应如何理解新《食品安全法》
By Huang Jianwen King & Wood Mallesons’ Investment Group
On April 24, 2015, the PRC Advertising Law was amended for the first time since its promulgation in 1994 (the “New Advertising Law”) and will take effect on September 1, 2015.
The New Advertising Law clarifies the definition of false advertisement, regulates online advertisement, advertisement targeting minors, and advertising endorsers. It reflects the government’s thoughts on deepening the reform, adjusting functions of government agencies, as well as strengthening market supervision.
Continue Reading The Amended PRC Advertising Law’s Impact on Health-related Advertisements
2015年4月24日，《广告法》自1994年颁布以来首次被修订，修订后的《广告法》（“新《广告法》”）将于9月1日正式实施。
本次修订涉及面广，修改幅度大：其明确了虚假广告的定义，对互联网广告、未成年人广告、广告代言人等都作了具体的规定，体现了全面深化改革、调整政府职能、加强市场监管的思路。
新《广告法》加强了医疗、药品、医疗器械、保健食品等医药健康类广告（“医药健康类广告”）的监管，明确工商与食品药品监督管理等部门的职能，加大了处罚力度，促进公众的参与监督意识。主要亮点如下：
Continue Reading 《广告法》修订对医药健康领域广告影响
By Huang Jianwen King & Wood Mallesons’ Investment Group
On April 24, 2015, the newly amended Drug Administration Law of PRC (“Drug Administration Law”) was passed by the 14th session of the Standing Committee of the National People’s Congress and took effect on the day of promulgation. Previously the Drug Administration Law was amended twice, respectively in 2001 and 2013.
The 2015 revision amends or deletes Article 7, 14, 55, 89, and 100. The three highlights of the new Drug Administration Law are as follows:
Continue Reading Analysis of the revisions in the Drug Administration Law
2015年4月24日，新修订的《药品管理法》于十二届全国人大常委会第十四次会议表决通过，自公布之日起施行。此前《药品管理法》曾于2001年、2013年进行过两次修订。
本次修改共五处，涉及条款为第七条、第十四条、第五十五条、第八十九条和第一百条。亮点主要集中在以下三点：
Continue Reading 解析《药品管理法》的再修订
By Huang Jianwen, King & Wood Mallesons’ Investment Group
The amended PRC Food Safety Law (the “2015 Food Safety Law”) is regarded by many in the media as the harshest food safety law in history. The liabilities of food safety violators are significantly increased under the new food safety legislation. Moreover, it establishes a new and more refined food safety regulatory system that gives food safety regulators broader and more robust supervisory powers. The 2015 Food Safety Law was passed by the Standing Committee of the National People’s Congress on April 24, 2015 and will take effect on October 1, 2015.
Continue Reading Selected Highlights of the Amended PRC Food Safety Law
2015年4月24日，新修订的《食品安全法》在两次审议、三易其稿后，于十二届全国人大常委会第十四次会议表决通过，并将于2015年10月1日起正式实施。与2009年的《食品安全法》相比，新修订的《食品安全法》在篇幅和内容上均有大幅扩展——条款从104条增加至154条，字数从1.5万字增加至将近3万字。
根据全国人大常委会法工委行政法室副主任黄薇介绍，此次修改反映了以法律形式固定监管体制改革成果、完善监管制度机制；完善监管制度、解决当前食品安全领域存在的突出问题；以及建立最严厉的惩处制度、发挥重典治乱威慑作用的三方面需要。
Continue Reading 新《食品安全法》修订亮点
By kingandwood Mallesons’ Healthcare Group
On 31 March 2014, Chinese government released the revised Regulations on the Supervision and Administration of Medical Devices (“Revised Regulations”). The Revised Regulations will come into effective on 1 June 2014, presenting following major changes:
Classification and Supervision System Adjustment
According to the Revised Regulations, medical devices are still supervised and managed under a Class I, Class II and Class III system based on the risk to the users. However, the supervisory system has been changed with below highlights.
Continue Reading China’s Revised Regulations on the Supervision and Administration of Medical Devices: New Supervisory System and Increased Penalties
