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Life Sciences & Healthcare

China

As a participant in the lifesciences and healthcare industry, you know that discovery and innovation are key to finding lasting health solutions. Yet due to the highly regulated nature of the industry, you - a corporate, investor or start-up - must overcome complex administrative, compliance and liability hurdles before your products and services can come to market. With over 150 international specialists across CMS and the support of the Lifesciences Asia-Pacific Network (LAN), we understand the scientific and commercial as well as the legal imperatives affecting your business.

Our experts, many of whom have worked in-house in your sector, have developed a shared capability in the areas of pharmaceuticals, biotechnology, medical devices and diagnostics. With active memberships in the major industry associations such as the ABPI, ABHI, BIVDA, PAGB, EUCOMED and EFPIA, we help shape the legal frameworks impacting the lifesciences sector. We regularly advise our clients on their day to day operational needs such as support with public sector procurement, patent prosecution and enforcement, commercial agreements, tax and transfer pricing, and regulatory advice. Equally, when you need lifesciences specialist advice for strategic agreements, planning a corporate transaction or embarking on litigation (whether product liability or otherwise), we have a team that is well versed in the industry issues to help you.

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11/07/2016
Ex­pect­a­tion of a Faster Growth of Health Food in Near...
China In­sight - Lifes­ci­ences
05/04/2016
New GCP of Med­ic­al Devices
China In­sight - Lifes­ci­ences
05/04/2016
China En­cour­ages In­nov­at­ive Drug by Modi­fy­ing Its Drug...
China In­sight - Lifes­ci­ences

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Marite Aragaki
Dec 2018
CMS Life Sci­ences & Health­care Sec­tor Group: An over­view...
23/08/2019
China launches new drug re­im­burse­ment list, 148 drugs ad­ded
On 20 Au­gust 2019, Chin­a's Na­tion­al Health­care Se­cur­ity Ad­min­is­tra­tion (NHSA) and Min­istry of Hu­man Re­sources and So­cial Se­cur­ity (MOHRSS) jointly is­sued the Cir­cu­lar on the Na­tion­al Drug Cata­logue for Ba­sic Med­ic­al In­sur­ance, Work-re­lated In­jury In­sur­ance.
20/08/2019
High­lights on re­cent reg­u­la­tions on cus­tom­ized med­ic­al devices
On 26 June 2019, the Na­tion­al Med­ic­al Products Ad­min­is­tra­tion (“NMPA”) and the Na­tion­al Health Com­mis­sion is­sued the “Pro­vi­sions on the Su­per­vi­sion and Ad­min­is­tra­tion of Cus­tom­ized Med­ic­al Devices (Tri­al)” (the “Pro­vi­sions”), which will be im­ple­men­ted from.
13/08/2019
Ex­ten­sion of Pi­lot Re­gime of Med­ic­al Device Hold­er
The Na­tion­al Med­ic­al Products Ad­min­is­tra­tion (the “NMPA”) pro­mul­gated the No­tice of Na­tion­al Med­ic­al Products Ad­min­is­tra­tion re­gard­ing the Ex­ten­sion of Pi­lot Re­gime of Med­ic­al Device Hold­er on Au­gust 1, 2019 (the “No­tice”).
13/06/2019
Chinese state coun­cil re­leases reg­u­la­tion on the hand­ling of hu­man...
The State Coun­cil of the People's Re­pub­lic of China (PRC) re­leased the Ad­min­is­trat­ive Reg­u­la­tion on Hu­man Ge­net­ic Re­sources, which de­tails the hand­ing of hu­man ge­net­ic re­sources (i. e. ge­net­ic ma­ter­i­als such as or­gans, tis­sues, cells, gen­omes and genes) and.
30/05/2019
No­ti­fic­a­tion with re­gard to the fol­low-up works of the can­cel­la­tions...
The De­cision of the State Coun­cil on the Can­cela­tion and Del­eg­a­tion of a Batch of Ad­min­is­trat­ive Li­cens­ing Items pro­mul­gated by the State Coun­cil on 27 Feb­ru­ary 2019 (“De­cision Guo Fa [2019] No. 6”) has can­celled 25 items of ad­min­is­trat­ive ap­provals, among.
28/05/2019
China Life Sci­ences & Health­care Monthly Up­date - April/May 2019
NMPA re­leases draft pro­vi­sions of on-the-spot in­spec­tions for drug re­gis­tra­tion: 17 May 2019 The Na­tion­al Med­ic­al Products Ad­min­is­tra­tion ("NMPA") of the People's Re­pub­lic of China ("PRC") re­leased the draft for the Ad­min­is­trat­ive Pro­vi­sions on On-the-spot.
25/03/2019
China re­leases the draft Safety Man­age­ment Reg­u­la­tions for Bi­o­tech­no­logy...
The Min­istry of Sci­ence and Tech­no­logy of the People's Re­pub­lic of China re­leased the Safety Man­age­ment Reg­u­la­tions for Bi­o­tech­no­logy Re­search and De­vel­op­ment (Draft for com­ments) ("Draft") on 11 March 2019.
12/03/2019
China Life Sci­ences and Health­care monthly up­date - March 2019
State Coun­cil will de­ploy fur­ther pref­er­en­tial policies for anti-can­cer drugs over 2019, 19 Feb­ru­ary 2019 In an ex­ec­ut­ive meet­ing on 19 Feb­ru­ary 2019, the State Coun­cil of the People's Re­pub­lic of China ("State Coun­cil") an­nounced that six pref­er­en­tial policies.
17/12/2018
China Life Sci­ences & Health­care Monthly Up­date - Decem­ber 2018
SAMS Con­sulta­tion on Vac­cine Man­age­ment Law, 11 Novem­ber The State Ad­min­is­tra­tion for Mar­ket Su­per­vi­sion (“SAMS”) of the People's Re­pub­lic of China (“PRC”) re­leased the PRC Vac­cine Man­age­ment Law (Draft for com­ment) (“Draft”) on 11 Novem­ber 2018.
17/12/2018
China launches an in­ter­pro­vin­cial medi­cine pro­cure­ment re­gime
Fol­low­ing the fifth meet­ing of the Cent­ral Com­pre­hens­ively Deep­en­ing Re­forms Com­mis­sion of the Com­mun­ist Party of China, the Joint Pro­cure­ment Of­fice of the People’s Re­pub­lic of China (“JPO”) re­cently re­leased the Medi­cine Cent­ral­ised Pro­cure­ment Doc­u­ment (“Doc­u­ment”).
21/11/2018
Ex­ten­sion of pi­lot peri­od of MAH Hold­er Sys­tem
Fol­low­ing the pro­mul­ga­tion of the De­cision of the Stand­ing Com­mit­tee of the Na­tion­al People’s Con­gress on Au­thor­iz­ing the State Coun­cil to Carry out the Pi­lot Drug Mar­ket­ing Au­thor­iz­a­tion Hold­er Sys­tem in Cer­tain Re­gions and Rel­ev­ant Is­sues on Novem­ber 4, 2015.