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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 more than 300 lawyers, patent attorneys, scientists and academics 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 Fu­ture
The Ad­min­is­trat­ive Meas­ures for the Re­gis­tra­tion and Re­cordal of Health Food (“Meas­ures”) ad­op­ted and pro­mul­gated by China Food and Drug Ad­min­is­tra­tion ("CF­DA") on 4 Feb­ru­ary 2016 have come in­to force on 1 Ju­ly 2016.The above Meas­ures give more clar­ity to health food man­u­fac­turer or dis­trib­ut­or in terms of man­u­fac­tur­ing and im­port­ing of health food in China.The Meas­ures provide a new two-track ad­min­is­trat­ive sys­tem and a more ef­fi­cient guideline for health food in­dustry. Com­pared with the cur­rent reg­u­la­tion (i.e. Tri­al Im­ple­ment­a­tion of Health Food Re­gis­tra­tion, “Tri­al Im­ple­ment­a­tion”), the Meas­ures sim­pli­fy and op­tim­ise the pro­ced­ure for health food re­gis­tra­tion, and parts of the health food (formerly sub­ject to re­gis­tra­tion pro­cess) are now sub­ject to re­cordal. This will help to shorten the peri­od to meet reg­u­lat­ory com­pli­ance of health food on the Chinese mar­ket. The new re­gime is also be­ne­fi­cial for for­eign health food man­u­fac­tur­ers who mainly carry out these goods through on­line sale, mainly those who man­u­fac­ture nu­tri­tion com­ple­ments, such as vit­am­in and min­er­als.Ac­cord­ing to the 2015 an­nu­al re­port is­sued by CF­DA in Feb­ru­ary 2016, 987 re­gis­tra­tions of health food cases have been ap­proved and 513 al­ter­a­tion ap­plic­a­tion cases have been ap­proved in the year 2015. It can be ex­pec­ted that after the pro­mul­ga­tion of the Meas­ures, the num­ber of both re­gistered and re­cor­ded health food will have a much faster growth in the near fu­ture.Please click the be­low source link to read the full con­tent.
05/04/2016
New GCP of Med­ic­al Devices
On 23 March 2016, the China Food and Drugs Ad­min­is­tra­tion (“CF­DA”) and Na­tion­al Health and Fam­ily Plan­ning Com­mis­sion (“NHFPC”) jointly is­sued the new Good Clin­ic­al Prac­tice of Med­ic­al Devices (“New GCP”). This New GCP will re­place the Pro­vi­sions on Clin­ic­al Tri­als of Med­ic­al Devices ef­fect­ive from 1 April 2004. The New GCP will take ef­fect from 1 June 2016 but it will not ap­ply to in vitro dia­gnost­ic re­agents.Ac­cord­ing to the Ad­min­is­trat­ive Meas­ures of Re­gis­tra­tion of Med­ic­al Devices, the Class II and Class III med­ic­al devices, ex­cept those ex­emp­ted from clin­ic­al tests as pub­licly lis­ted by the CF­DA, are sub­ject to clin­ic­al test and their clin­ic­al tests need to be filed with the loc­al FDA. In ad­di­tion, the clin­ic­al tests of some Class III med­ic­al which have high risks fur­ther need to be ap­proved by the CF­DA. There­fore, the New GCP will have lar­ger im­pact on the clin­ic­al tests of Class II and Class III med­ic­al devices.The New GCP has 11 chapters, in­clud­ing (1) gen­er­al prin­ciples, (2) pre­par­a­tion for clin­ic­al tri­al, (3) pro­tec­tion of rights of sub­jects, (4) pro­gram of clin­ic­al tri­al, (5) du­ties of eth­ics com­mit­tee, (6) du­ties of ap­plic­ant, (7) du­ties of clin­ic­al tri­al en­tit­ies and re­search­ers, (8) re­cords and re­ports, (9) ad­min­is­tra­tion of med­ic­al devices for clin­ic­al tri­al, (10) ad­min­is­tra­tion of ba­sic doc­u­ments and (11) mis­cel­laneous. It has enorm­ously ad­ded the rules of clin­ic­al tri­al to be com­plied with by ap­plic­ant, eth­ics com­mit­tee, clin­ic­al tri­al en­tity and re­search­er and in­creased the pro­tec­tion for sub­jects. Du­ties and ob­lig­a­tions of rel­ev­ant parties in the clin­ic­al tests of med­ic­al devices will be stream­lined and the ap­plic­ants for clin­ic­al tests, i.e. man­u­fac­tur­ers of med­ic­al devices, will be much more af­fected by this New GCP. The main con­tents of the New GCP are as fol­lows:A chapter re­gard­ing pre­par­a­tion for clin­ic­al tri­al is ad­ded in the New GCP. It adds some more con­di­tions for car­ry­ing out clin­ic­al tri­als, in­clud­ing provid­ing the test re­port made by a qual­i­fied test­ing en­tity with­in 1 year, hav­ing filed the clin­ic­al tri­al with the loc­al pro­vin­cial FDA, hav­ing ob­tained the ap­prov­al for clin­ic­al tri­al of Class III med­ic­al device.In the chapter re­gard­ing the pro­tec­tion of rights of sub­jects, in ad­di­tion to keep the list of in­form­a­tion re­gard­ing the clin­ic­al tri­al to be dis­closed to sub­jects in the old Pro­vi­sions on Clin­ic­al Tri­als of Med­ic­al Devices, the New GCP adds the ob­lig­a­tions of an ap­plic­ant for clin­ic­al tri­al to provide the eth­ics com­mit­tee with a series of doc­u­ments for eth­ics con­trol, to re­port to the eth­ics com­mit­tee the ser­i­ous ad­verse events, status of clin­ic­al, and de­vi­ations in the clin­ic­al tri­al, etc., and not to mis­lead the sub­jects by ex­ag­ger­at­ing the in­dem­ni­fic­a­tion for re­ceiv­ing the clin­ic­al tri­als.A chapter re­gard­ing the pro­gram of clin­ic­al tri­al is ad­ded in the New GCP. It re­quires that an ap­plic­ant for clin­ic­al tri­al is ob­liged to pre­pare the pro­gram of clin­ic­al tri­al and iden­ti­fies the scope of such pro­gram. Oth­er­wise, there is no guideline for car­ry­ing out clin­ic­al tri­als.The chapter re­gard­ing the eth­ics com­mit­tee’s du­ties is also a newly ad­ded chapter in the New GCP. This chapter spe­cifies the com­pos­i­tion of the eth­ics com­mit­tee, the qual­i­fic­a­tions of its mem­bers and rules of pro­ced­ure. The eth­ics com­mit­tee is gran­ted the rights to sus­pend and ter­min­ate clin­ic­al tri­als.It is spe­cified in the New GCP that the ap­plic­ant for clin­ic­al tri­al shall be re­spons­ible for the truth and re­li­ab­il­ity of clin­ic­al tri­al data. It is a dif­fi­cult ob­lig­a­tion to be per­formed by the ap­plic­ant in the cur­rent prac­tice. At present, the num­ber of ex­ist­ing med­ic­al in­sti­tu­tions which can carry out clin­ic­al tri­als is far be­low the de­mand for clin­ic­al tri­als. It is quite of­ten that an ap­plic­ant can­not con­trol the status of a clin­ic­al tri­al by a med­ic­al in­sti­tute. In or­der to im­ple­ment such re­spons­ib­il­ity, the New GCP re­quires the ap­plic­ant to es­tab­lish mon­it­ors to carry out mon­it­or­ing over the en­tire pro­cess of clin­ic­al tri­al and sets out the de­tailed du­ties of such mon­it­ors.The New GCP also ex­tends the term for keep­ing the re­cords for clin­ic­al tri­als. The med­ic­al in­sti­tute shall keep the ma­ter­i­als for clin­ic­al tri­al for 10 years after end­ing of a clin­ic­al tri­al and the ap­plic­ant shall keep such ma­ter­i­als un­til no longer use of such med­ic­al device, which is deemed to be an in­fin­ite peri­od.In re­spect of clin­ic­al tri­al of med­ic­al devices, the New GCP is one of reg­u­la­tions to be en­acted ac­cord­ing to the Su­per­vi­sion and Ad­min­is­tra­tion Reg­u­la­tion of Med­ic­al Devices. The oth­er one is the Ad­min­is­trat­ive Meas­ures on Veri­fic­a­tion of Qual­i­fic­a­tion of En­tit­ies for Clin­ic­al Tri­al of Med­ic­al Devices. The draft of such reg­u­la­tion was is­sued for pub­lic com­ments in Ju­ly 2015 and it is en­vis­aged that this draft may be passed and en­acted
05/04/2016
China En­cour­ages In­nov­at­ive Drug by Modi­fy­ing Its Drug Clas­si­fic­a­tion Rules
Fol­low­ing the new rules of clas­si­fic­a­tion of med­ic­al devices ef­fect­ive as of 1st Janu­ary 2016, the China Food and Drug Ad­min­is­tra­tion (“CF­DA”) is­sued a cir­cu­lar re­gard­ing the re­form of chem­ic­al drug re­gis­tra­tion clas­si­fic­a­tion on 4 March 2016 (“Cir­cu­lar”). This new Cir­cu­lar has come in­to force on the date of pub­lic­a­tion.Please click the be­low Source link to read more de­tails.

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6/5/20220
High­lights on the Re­vised Drug Re­gis­tra­tion Ad­min­is­trat­ive Meas­ures
20 April 2020
CMS Ex­pert Guide to Ad­vert­ising of Medi­cines and Med­ic­al Devices
This Ex­pert Guide provides high level in­form­a­tion on life sci­ences and health­care ad­vert­ising in 27 jur­is­dic­tions and of­fers a quick and simple un­der­stand­ing of the ap­plic­able laws. The Ex­pert Guide cov­ers, amongst oth­ers, dif­fer­ent types of ad­vert­ising, reg­u­lat­ory as­pects as well as leg­al con­sequences of non-com­pli­ance.
04 June 2020
High­lights on the Re­vised Drug Re­gis­tra­tion Ad­min­is­trat­ive Meas­ures
The re­vised Drug Re­gis­tra­tion Ad­min­is­trat­ive Meas­ures (the “Re­vised Meas­ures”) pro­mul­gated by the State Ad­min­is­trat­ive for Mar­ket Reg­u­la­tion (the “SAMR”) of the People’s Re­pub­lic of China (the...
6/4/2020
High­lights on the Re­vised Drug Re­gis­tra­tion Ad­min­is­trat­ive Meas­ures
03 June 2020
High­lights on the Ad­min­is­trat­ive Meas­ures on Su­per­vi­sion of Phar­ma­ceut­ic­al...
The Ad­min­is­trat­ive Meas­ures on Su­per­vi­sion of Phar­ma­ceut­ic­al Man­u­fac­tur­ing (the “Meas­ures”) pro­mul­gated by the State Ad­min­is­tra­tion of Mar­ket Reg­u­la­tion on 22 Janu­ary 2020 will be im­ple­men­ted in less...
6/3/2020
High­lights on the Ad­min­is­trat­ive Meas­ures on Su­per­vi­sion of Phar­ma­ceut­ic­al...
02 June 2020
Chinese Tax Reg­u­la­tion Up­date May 2020
The latest de­vel­op­ment in China Tax Reg­u­la­tion mainly in­cludes: An­nounce­ment [2020] No. 22 jointly re­leased by the Min­istry of Fin­ance (“MOF”) and the State Ad­min­is­tra­tion of Tax­a­tion (“SAT”)...
4/9/2020
New re­quire­ments re­lated to the ex­port of cer­tain med­ic­al devices re­lated...
29 May 2020
Shang­hai is­sues Six­teen Meas­ures to Pro­mote In­dus­tri­al In­vest­ment by De­vel­op­ment...
To pro­mote the de­vel­op­ment of and re­duce neg­at­ive im­pacts of COV­ID-19 on in­dus­tries,   as well as sta­bil­ize  eco­nom­ic growth, on 18 May 2020, the People’s Gov­ern­ment of Shang­hai Mu­ni­cip­al­ity (the...
03/02/2020
Does the Coronavir­us Out­break con­sti­tute Force Ma­jeure?
22 May 2020
For­eign in­vest­ments in Ger­man life sci­ence com­pan­ies be­come sub­ject to...
In re­sponse to the COV­ID-19 pan­dem­ic, Ger­many has widened the scope of its in­vest­ment con­trol to in­clude nu­mer­ous life sci­ence com­pan­ies. The amend­ments to the For­eign Trade and Pay­ments Or­din­ance ("AWV")...
17/01/2020
CMS, China ranks in ten prac­tice areas in Leg­al 500 Asia Pa­cific 2020 Edi­tion