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ܿѧ | EMAܿѧ2025ս˼ ѡ

  • 2020-06-27 09:55
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  • Դƽ.15999909920

ƽҩƷܿѧǵҩƷܻʵҩƷִشսѡƽҩƷܿѧչУҺ͵ƶҩƷܿѧսԣȫֺսϹ滮ҩƷܿѧչĿꡢصͷȡ20203£ŷҩƷල֣EMAEMA ܿѧ2025ս˼ּڽһӦԵļϵҩﴴ¡ļŲ֣EMAֳGuido RasiǰԡҩչԸҩչԸܼܿ顢ս˼ҩܿѧսĿꡢҩܿѧĸսĿꡢͬЭʼܿѧԼԴʱΪӿƶҹҩƷܿѧо뿪չֽEMA ܿѧ2025ս˼ҩ֣оο


EMAܿѧ2025ս˼

ѡ

   



1.ܿѧָӦҩƷȫԺЧһϵпѧѧƣҩƷΪṩϢӦҽѧԼѧּڿܱ׼͹ߡ


Regulatory science is defined as the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.


2.Щ꣬²٣ԽԽҩͨϲͬṩҽƽܻҪ׼֧渴ӵҩзٽͱͶ。


The pace of innovation has accelerated dramatically in recent years and regulators need to be ready to support the development of increasingly complex medicines that more and more deliver healthcare solutions by converging different technologies to promote and protect human and animal health.


3.Ϊǿ䱣ཡʹEMAƶܿѧʹתΪϷչҽϵл߶ҩĿɼԡ


To underpin its mission of protecting human health, EMA must catalyse and enable regulatory science and innovation to be translated into patient access to medicines in evolving healthcare systems.


4.ӦԴ´Ĺͬս濪չʺͨϽ⡢Դ㼯Լܹߡ׼ͬЩ⡣


International cooperation in dealing with the common challenges posed by innovation helps solve these complexities through joint problem solving, resource pooling, capacity building and the convergence of regulatory tools and standards.


ǰ


Guido RasiڣEMAֳ


EMAǡѧҩƷζſѧŬȷߺͶҩƷɼ㹫ڽһйĻ


Щ꣬²٣ԽԽҩͨϲͬṩҽƽܻҪ׼֧渴ӵҩзٽͱͶ。


ȫҰҺ͵Ƕӽɨʾ˼ȤЩּȷܻӰϵĿѧͼĹؼ¡


βսǵļ


׼ݡ׼ҽѧ졢ٴƺͺϳѧ˿Ƽ½ӹ


Ƿ߱ҪļܡǷȷʵܹȡҪضרҵ֪ʶ


ǷƶµָϻṩĽԴʹЩ¿ƼӦúת


ҪѧίԱϯ˼ЩⲢδļܿѧսԵԭһսͨٿֻʽȡҪߵƶġ


DZӢŷҵͬʱŷҩƷδ5-10ҪӭĸսںܶҪȫŷ޼ǿЭŻ»ҩɼԣŷ޲ҽƱҩ棬δ꣬ǽ١ҩܷEU2019/6ʵʩֱսͬʱDZ뽫Ŀ⿴øԶڡҩܷEU2019/6֮⣬ӭ¼תΪҩзĻս


һսԵIJǽŷ˳ԱŷίԱǵƶһŷ޼2025սԡĹؼҪءһսԽʹǸϷչIJȷѧҽϵ֮IJ࣬ŽڶֺЩࡣ


ҩչԸ


Ϊǿ䱣ཡʹEMAƶܿѧʹתΪϷչҽϵл߶ҩĿɼԡ


ҩչսĿͺĽ


1ٽѧ뼼ҩзеں


֧־׼ҽѧ͡ѧķչ


֧ȽҩATMPsתΪƷ


ƽͶPRIMEƻ


̴ٽ켼Ӧã


̽ҽеԼͱԵƷۺ·


߶׼ҽҩ²ϵ֪ͼܶԲߣ


̴ٽҩзڼܽĶһ廯


2ƶЭ֤ͬݵɣĿѧ


ʹ÷ٴģͺѭ3Rsԭ


̴ٽٴ鴴£


̿ٴɵļܿܣ



ͶȺжƻ


Żģ


ּ˹ܽоߡ


3ҽƱϵͳٽԻΪĵҩɼ


HTAԴҩ׼ξߣ


֧ͨЭʵִɼŽӣ


ǿ֤еĻԣ


ƽʵݣRWDھеӦã


̷չרҺԴݣ


ԵӸʽǿIJƷϢePI


̴ٽҽϵͳҩӦüܶȣ


̽һٽⲿ͹ͨŷ˼ϵκġ


4Ӧ³ֵĽвƿɼԷս


ִEMAĽвƻȦԴĽ׼


̼֧µĿؼĿ


̴ٽȫԤͽӦ⣻


֧зкĴ·


֧֡ҩáܵƶʵʩ


5ֺ֧üܿѧеоʹ


ѧоķչĻϵչܿѧսо


ѧѧ֮ĺٳֵļܿѧо⣻


ʶͻȡŷ޺͹רҵ֪ʶ


缰ƹͽרҵ֪ʶܺʹµ㡣


ҩչԸԣ


һ顪ܿ


ŷҩƷϵͳŷEMRNһŷ޾ԱҩƷܻҩҩEMAŷίԱṲͬɵЭ硣һصϵͳŷ4ڶ˿ڡ


һռĿͨҩƷٽͱȺĽζҪŷ޵˺ͶﶼܼʱõȫЧϸҩƷӦͬʱҩƷʹõıҪϢƷ֪ѡȨ


⣬ŷ˼绹ṩܻ֧ҩҩĴºͿӶͶĽΪˣDZʹٽܿѧչ߱йϵ


ʲôǼܿѧ


ܿѧָӦҩƷȫԺЧһϵпѧѧƣҩƷΪṩϢӦҽѧԼѧּڿܱ׼͹ߡ


ſѧͼIJϽDZڵµƺϹ֣֮ܿѧ֮ͷȷϸЧضЩƷԼܿѧ̲شӰתоϸƷڻѧϡҩеϲƷٴơԤⶾѧʵ֤ݡݼ˹ܡ


Ŀ


ļڼܿѧDZо˼ʶѧϢʹѸٸıᣬرҩзܻһ


ˣŷ˼ܹȡáµĿѧݡõķ͹ߣڴ˻֮ߡͬʱʶֻܻǾеһҪأܻڸ汣ֺߡЭԱϻߡҽԱҩƷȡʹþҩƷϢ˵ΪҪļⶨĿꡢжּȷܻδܹһڽΪŷ޾ṩѵҩƷܡͬʱЩĿꡢжҲϹɿɳչĿʵ֣ҪǿɳչĿ33.43.D


˭ǵߣ


ĹΪ˻ߺͶ档ԼǵҽרǼʹĺġΪ˸õطǣͨչᣬDZͬʱѧо塢ܻа֧ҩҵЩɵĶԪȺڼķչи԰ŲͬĽɫ


ս˼


һս˼EMAĹؼ˹飬ĿȷEMAʹȫµĿѧսҲӵмܹߣԼּ֧Ĺʵ䲻ϷչʹļȷҩսĿҩӦĸսĿ꣬Ҫ֧ЩĿĺĽж


սеĿͽڶߺġ


սĿͽģ


EMA߸ѧίԱŷҩƷзźãDZ붨ڲƽܿѧչһEMA깤ƻ滮ͼලģѧЭίԱᣨSciCoBoЭ


2016еһӰУʶ˽ս˼ıҪԡĿʵ޼Դŷ䣬ȷԴӰĵбӢ˳ŷˣһøС


ս˼ʼǰ2017EMAѧЭίԱҪдһϸĻ棬չEMAͼвӰĿѧͼܷҪơһ潨EMAѾչĴĹڷչӽɨ֮ϡ


ΪĿھͽУEMAҩз·ĸ߿չһϵй㷺а


ҽרҺͻߴ


ŷоʩ硢ѧ֯Эᡢѧѧ


̼ܿѧרңEMAйϯѧѯϯ


֧


ҵСҵҵЭ


ЩijɹսսļΪȷ㷺ܹļ2018׿ʼΪ¡ڼյ˴ķ


EMAҪδΪʹϵͳĺĽ顣


ҩܿѧսԣԸطǰλĽΪٽٴ鴴£ٽʵھеӦãǿ֤еĻԣHTAԴҩǰ׼ξߣ֧־׼ҽѧ͡ѧչΪ-뽻֧ȽҩתΪƷҽеԼͱԵƷۺ·ٽҩзڼܽĶһ廯ѧͼѧ֮Эٳֵļܿѧо⡣


2019꣬EMAٿ˶ֻᣬоȷδ꽫شĺĽ顣


ͨԹڼֻյķзEMA޸ĺĺĽصжУսԽ˸¡󵽵Ĺ㷺ȷսеĶжЩھ壬ûбСǽھִзеõ֡


ִзΪսеÿĽصжȷȼͿɿĽЩתΪжƻEMAѧίԱᡢĹƻ⣬йصжδӰķչЩжͨŷҩƷԻHMA깤ƻ͸ԱҩƷֹܵƻֺʵʩ


ҩܿѧսĿ


EMAѰƶܿѧչȷѧ֪ʶĽתΪµġȫЧĻƷ


ҩķչԸǣΪǿ䱣ཡʹEMAƶܿѧʹתΪϷչҽϵлߵĻøС


ΪˣEMAսĿ꣬ÿսĿ궼һ׺Ľ֧ж


3.1 Ŀһٽѧ뼼ҩзеں


ڽռĿȷܹ֧ҩʹ¼зӶܹͨӰȫЧٴʺϵƷ㻼ҪԻΪĵҽơ׼ҽѧ͸ԻҽƷչ


ϣµĿѧͼ֪ʶ뵽ҩзУӶʹڽ档ҪEMAѧоġʩλȼǿЭͬʱȷһѾ뵽һ̸׶μܻзĶԻСֶԻڱ֤ɼƻȷʵܹպе˵ҪӶʹֻμصġоĿڱֺͷչлƵĻϣرǻѾΪŷ˼·ɹĿѧѯ̣EMAºĽ顣


3.1.1֧־׼ҽѧ͡ѧķչ


׼߸ԻҩȺ鵼ҩ߼IJͬ׶εİҩҲϸȸԻƷӦáĿĻڡѧӦãǴٽ׼ҽѧչĹؼء


ڻλȡѻ鵼ҩһ˵ڸڽԵΪҪEMAӦһӦΪض嶨ƺĸӵҩµƷпܻij֤ɺʹݴķҲ뵽ܹУԴʹ׼ҽѧ뵽ҽϵͳ


ĿǰEMAڿչһϵжּƶ϶ķ/ָԭ϶Ч򣬲ٽߵĻ


Ϊ֧һ飬EMAȡж


̼ǿ↑ߵڽӴԴٽʸ֤


ϸEMA֤ij򣬰֤ʱԤ֤ԵĻᣬӶﱻ㷺ؽܺӦã


Ӧ˵ġѧӦڲƷӰ죻


HTA֧ͻߺƷٴӰ죻


ŻڸԻҩ↑ŷ޻оʩ


3.1.2֧ȽҩATMPsתΪƷ


ATMPϸƷ̲֯Ʒƣҩо޴DZ༭ȼDZơǰƷ޷ȫ˵һϵм


ȻעATMPdzޡⲿֹһЩ͹أƷͨҽԺ;һЩҵõʹáЩƷ֤ɴսƷ֤ɵŷ˼缰ʺеЭATMPٵսƷǰзѧСҵ𣬶ЩͨҪļܽ飻ƷϸƷĿʹãȶ͸Чص͵߲⣻ʱ漰⡣⣬Ҫ͵֧ʽȷATMPĿɸԺͿɼԡ


EMAһѾܶŬи๤ҪӦATMPǰսδ˼չ⡣ˣEMAȡжٽŷATMPķչӿ컼߻Ƶٶȡ


ʶܹӦδҽƷ


ЭATMPڹ滮ٴ


ӦATMPɢս


֧ξص֤ɣ


ǿATMPsйصġŷػоͻ֮Ļ


ȫATMPʶ޶ʵ֪ʶٽռ


ʼܻٽATMPҪȫͬ


3.1.3ƽͶPRIMEƻ


PRIMEƻ20163ּΪо޴DZδҽҩṩڵġǿĿƼͼ֧֡ϿüƻѾɹһЩ飬Լӿҩзʱ׼һЩҩȷʵܱļ


EMAоһĽüƻȻPRIMEƻԴܼĿҪڡʱشӼϵʵרҵ֪ʶͬʱܶƷк֤ҲҪõ㷺ļ⡣HTAIJdzҪѧܹǵ֤Ҫ󣬴Ӷƽҩﱨͻ߿ɼйؾߵƶΪٽPRIMEƻõõͽһķչEMAбҪҪߣŷ˴磩Ļ֮ϣԱȷ֧PRIMEƻѡߣ뻼ߡҽרҡѧFDAPMDAȹʺǿЭ⣬EMAҪһŻǰļϵȷҩԤ֤֤ͬʱ㻼߼ʱҩҩʱ䡣


ΪˣEMAȡж


̼ǿⲿͨõƽPRIMEƻ


PRIMEƻĿѧ飬ʵֳԣʶԵۻ᣻


ŻĿǰ֧PRIMEƻļϵڱ֤ɸͬʱҩзг֤MAʱ䣬ҩĿɼԣ


üƻִȷԹڽԤڵӰ죨ٽ߸ҩƻķΧҪݣ


̽뻼ߡҽרҡѧ͹ʺһӴͺĻ᣻


ֽ̽PRIMEƻ׼뷶Χ󵽸㷺˿ܻӰ档


3.1.4ٽ켼Ӧ


ƼķչʹµġЧҩʽΪܡЩµʽܶ࣬죬һͳķʽԭһ˲ͶţһͷּƷٱ죨3DӡּӵĶƲƷ㵥ߵ󣬼ȰڻҲô·ATMPIJ̡ͨԵֹߺݣЩ˷ѣһָķʽҩƷضġԵҽˣϵӦٽЩӦá


Щ¼ܲȫڴͳļģʽȷͬʱҪ޸GMPҪͱ׼ƶļָϺͼⷽʽԴٽ¼Ӧá⣬ܻҲҪרҵ֪ʶԱЩ¹̽гּල


ΪˣEMAϵͳӦ


պͷչ켼йרҵ֪ʶѵĿͼܹߣǿ̣


ʶDZڵƿǿ߾켼ļҪڻͨ͸ȣ


ͨЭʽƽؼָܷϵִӦԼսٽ켼չ


̹ӦûڷյĹڲƷãգƲԣ


GMPʵʩУٽĿӦķ


ַ֧չŷˡеҩսԷ롱ɫ켼


3.1.5ҽеԼͱԵƷۺ·


ԽԽҩеϸӲƷӿ֣£ԽԽԽһּ򵥵÷ʽϲƷ磬ijѧ/ҩѧѧƶٴ桪Ӱء⣬ԽԽĴҩصԼ


Ÿҩӣŷ˼ʶӦѰߺ·ҽеֺܵ͵ָ⽫Ҫŷ˼ڱⲻҪĸͬʱԴƷһָۺϵĻ桪Χ⣬ŷ˼绹ͨѧƵרҵˮƽִ֧ҩзõӦԲϱ仯Ļ


ǿԱԵƷļܾ߻ʹ棬ͬʱҲٽŷŵķչŷҽеԼܷѾҪijЩҩеϲƷļܽЭδЭʽҲܻ͵ҩеϲƷ


Ϊִ֧˽飬EMAж


̸ָҩƷܻ֮ļ·


ȡ෽߿ѧij֧ҩеϲƷʸ֤ԼĿ


ҽеܻ/ָѯ򣬾ҽеƷڸкȫ¼ѯ


ѯӦ͵ּͿɴ豸⣻


̽һרЭ磬ԲƷȫڽмܺṩ֧֣


̶ԵƷĻ-ͽʽ


ԡӽɨ衱ķʽ˽ҩеϲƷĴ¡


3.1.6߶׼ҽҩ²ϵ֪ͼܶԲ


¡ܡ̼һֿԤķʽıܣҩܺԴ׳߶ȵ֣ĿǰڱҩƷҽеǾһִҩƺ͸ĽϵͳDZԽδҽ


ȻĸԣҲһϵпѧͼܷս磬Ҫµļⷽпͱ׼ҪƷؼΪԡ


⣬ЩƷпҽеԵƷеѧ/ҩѧ/ѧƵĹ֡


ˣӦҽеܲŵкԻȡʵרҵ֪ʶȷδƷϸ


Ϊ˶׼²ϽбҪ˽⣬EMAȡж


ͨŷ˴߶ҩͲϵʶٽŷоģDG JRCʺ飨ҩܼƻIPRPĺԷ֪ʶЭʵ


ƶҩлѧҩЧӦѧPK/PDģҪЧİȫָϣ


ҩͰȫص¼ⷽпͱ׼


˽ƷĹؼԣCQAԼЩƷԺڷӦ֮Ĺϵ


3.1.7ٽҩзڼܽĶһ廯


ҽѧƼķٷչζҩзͼܻ֮ӦýиӼʱĻʵϣ߽еʱбҪչ硢ƵĶԻ֧ҩзһᵽĻ⡣ڱʵİȫϴʩ£ͨĽơ⻼ߵIJҪȷʽǿѧѯͼǿָ⽫ʹĶƷطߡ


ΪŻ߶ҩĿɼԣʹҩзܸ̾ЧӦڲƷз;߹ṩѧͼܵѯָߡҽרҡHTA֧Ӧڽ׶ξͲһ̡


EMAͶҪԴԼǿ͸ĽеĿѧѯƽ̨ʹƷѯܹӦԶַչѡΪˣEMA飺


̽ѯƣִ֧²Ʒͬʱطѯƽ̨


ƽߵԵĽܣõؽ֤ɵԡṩ¿ƼƵһԽ飻


̽ϿѧѯٴGCPʵʩļලٽΪۺϵҩ↑


ͨоƽ̨ҩʹõķǰҩյ㣻


ͨ鴴¹飨ITFٽתŷ˴ƽ̨Эͬչ


3.2ĿƶЭ֤ͬݵɣĿѧ


սԵڶĿĹĿΪܻHTA/֧ṩõ֤ݣּ֧;ߣӶȷڼܷմڻҩӰ£øࡢʱơһĿ껹ּڽͯ߻͹صĻȱЧƵ״


һĿҪصעֹҩƷ졢зٴƷСζſԴٴǰٴٵʵӦõҩƷڸ㷺Чռݡһǿ֤ɷʽͬʱṩһиõػȡƫõĻᣬʹٴͼܸ߳ɱЧ棬пܼҽϵͳĸ


3.2.1ʹ÷ٴģͺѭ3Rsԭ


ҩõķٴģ͵оϸٺͼģ⽨ģ鷽ǰҩɸѡеĽһӦãڽеоĿĿܻ꣬ҩз֧ҩЧоЩ3Rsأּڴ桢ٺ͸ƶ顣


ijЩоѴȼ٣ΪֹЩģύеʹʲߡһԭҩзҵļܻϿЩ·NAMʹãӶNAMӦõԭȱԴģȷйܵ˽⡢ȱģ֤ӦóɱˣҪʹЩʩٽNAMзԱĹͨٽܻŷ/ƽ̨ĽٽͨSAʸ֤Լֹߡݱ׼


Ϊַ֧ٴģͺ3RsԭӦãEMA½飺


̹зԱʵʹµķٴģͣѭ3Rsԭ


ŷ˻/ʵΪģ͵о׼洢ṩʽ


ƶȷָ룬ԹʹÿҪġϸѭ3RsԭNAM洫ͳ飻


ǿ3RϹ飨J3R WGã֧µͳġ3Rԭѭ͵ķ/ģ͵֤аģµ飻


Ӧ/ITߣֽ׼Standard for Exchange of Nonclinical Data, SENDĸӼֵ·ٴо֧ٴ顢ɺ֤ɡ


3.2.2ٽٴ鴴


ٴ鴴ṩһ֤øͳķ޷֤ġҩ洦ͨЧЧоһ㣬㷺ҩߺоԱȺIJ룬ܹԻΪĵҩɼԡ


ҩٴĴ¿ԴµƵӦáµյ㡢µݲɼáѧʵݵ¼ȺͼзࡣഴµذҪĻ١֤ҩЧͻ-յյޣԼּĻݼĿԣɴ豸¼Ļ߱⣬ٴ黹ҪˡиڵױȺ Ҳֱӵشол档


µƺԴҪ滮ͷʵͳƷҪµյ㣨磬ȡ֢ʱԼµ֧֤оյڿٴյ֮Žӡ


ܻҪߺػȷʵʩͷµơµķ˵ҪͬʱҪµķʹƵύ롢׼еļܼơͽΪܡУߵĹ۵ҪǵIJԼظĽƺʵʩͬʱ¿ҩﱾӦԡ


ͨߺоԱڵĹ㷺ߵIJ룬ٴơʵʩͷָԣͨ֯ICHΪƽʹʶЭԵ춨õĻ


ٴơʵʩͽϢķӦÿԴٽͼٴ£ͬʱǶٴ̼κ⡣ֹⷴоߺͻ߲С߲ϢĻϣصѵΪܣͬʱƶǽٴƺʵʩϵı仯


⣬ͨٴ鱾ƶٴյ㡢ҩΪģʽ켼ĻоٴϵĴ»ƽŷооרҵ֪ʶչ


Ϊٽٴ鴴£EMAȡж


̽һ෽߲ġƽ̨ʹµٴоΪܣŷ˶λΪٴоѡص㣻


ƶͲµٴʵٽٴɡGCPʵʩHTAŷ˺͹ʲĽܶȣ


ߡŷҩƷŷίԱƶʹٽչٴٴƣ


̴ٽٴơʵʩʵϢĽһЩϢͶ෽ƽ̨ΪʹѵʵΪܣӶһٴ±


Եµġϳֵٴյٴֵڴٽ߶ҩɼԷã


ƶٴ뱻Ⱥи˺ͲͬȺ


3.2.3ٴɵļܿ


δ꣬ٴּӦòݲռķʽشӰ죬һݱʲشӰ졣аԱij⡢߱ĽһʹԼݡڼеļɡΪԸ÷ʽռݵЧԵӰ죬ӦݵԱϡЩռݵԴٶȺζھͳƷΪЩݵĺ壬ҪһЩأ쳣ֵȱʧݺеݲԡ


һĿӦãݵ׻ȡԺһԣߺҽרңHCPҪ߷벢Զ̲ܻٴIJԣͬʱ߻ҽĿܻڼҪﲻų⣬ӶӰЧԡһķչУѵʵӦҪĹߡݵ˽ԺͰȫҲǼΪҪĿءˣбҪùеרҵ֪ʶԱȷǼܿѧҪӰ죬ƶʵļܿܡ


ΪƶһӦٴɷʽļܿܣEMAܻӦ


̿ٴԴܾߵķ


ȨͰȫй⣻


ʵGCPִܵʹɢٴģʽֱӵݼϣ


̿ɴ豸ȼĸݼ


̼ǿҽרҺͻ߶Դ˵ѵ⣬ԴٽЧؽӴͲ飻


ͨʸ֤ѧͽ෽ƽ̨ȷʽȡӦõķӶ֧յĿ


3.2.4-ͽ


ܻѾƶӦ˽ṹĻ桪ܣ԰ҩĻ桢ΣͲȷߺͽйͨµķڲ̽Уٴ鵽ƶȸµʵڱϿˣбҪоŹߣԿչ-ֺ֧ߡ


ھ߶ҩĿɼԷ淢ҪáܻӦŬʱҩĻ桢ռ-ƽͲȷؽϵͳĹͨԹξ߲οֺϼ׼֮ĺ蹵


ܻ߶Կ߱ͻƫϵͳҩз̵ķԼ桢ΣͲȷķdzȤԤ⽫ٽԻΪĵҩзܾߵ͸ȡȻȱٶӦõļָԭӰ޵ġ


ŷеļܻͨԻ߲ݼԷȻһԿԴӿɿݷЧ̽ʹܻܹпƷݷӶ޶ȵطݵáǣŷзչǸӵģҪԺͳԽ


ΪˣEMAȡж


뻼ƫΪ桪ṩϢ


ڻƫоơʵʩֵʵ½չ紴ҩжƻIMI PREFERƶָԭԴﵽĿģȷĸͶԣ


ͻƫڲͬҽƱͼܾеṩָƫΰܻٴΪṩϢδƫݵԻͻԣڼܾйͨƫã


;һԷ棬ƶṹĻ-֤ϵϵͳӦã


̼ǿҩ桢ΣͲȷԵĽṹԸĽ빫ڵĹͨ


廼ݵ֧ؾߣ


̾Ʊ밲ο/ԶıȽϡ߹۵ȣǿHTA֧Ĺͨ


3.2.5ͶȺжƻ


ŷ˿ڽṹı仯ʹEMAȫµĹȺˡͯںͲڸŮĹҽѧ濪չжǶҩһʶںͲڸŮҩȫĹҲڽС⣬ҩδġͨͳ;ռݵEMAƽһԷ֧͵ٴǰٴƣͬʱҲƽҩضȺڵĵʵʹɵ֤ٴݣ⻹ƶ˺ҩзڼۡ


ĿǰĶҩܿѾʵʩʮ꣬Զҩķչ˻Ӱ죬ҪһṩҪ֤ݣԸȺҩĿɼԡȫԡ磬ʵУԴһЩҩԶδĶ򣬱ѧѧҩȻ껼ߵijݣͬʱΪ˽⸾ŮǰڼʹҩĺعҲһǿչ


EMAж


ȷܹȡҩЧԡȫԵĸݵͬʱؼӿҪĻߣǻߣȺҩĿɼԣ


ʶȷҩԶδġٴܹٴݵ


̴ٽ/ߴҽԱܹ̣뻼ߡҽרңHCP֧HTAǿ෽ߵĽ飻


ƶҩսԵʵʩ


ƶŷҩƷܾ/ŷίԱᣨEMA/ECҩжƻʵʩ


ҩĶ෽жƻԽһ˽⼲ķƺͷչ̣չģִ֧ٴƣܹ׼ȷ¼Чյ㣻


ܻ͹߹ͬƶĸӤսжƻͨõ˽ͽںͲҩʹõĻ桢պͲȷԣٽҩɼԣ


೫Ӧҩлѧ/ҩЧӦѧPK/PDģ͡ŴѧֳоٴԼкоĿǣ


̹չо߼иҩﰲȫ⣨źż⣩ЧʺЧ


3.2.6Żģ


ģͷ棨ģҩз-MIDDΪԤṩһܡǴӻƺͼˮƽݵۺģ֪ʶƶϡ


Ʒһִٽ罨ģͷ棩ʹõĿܣ԰һԴȺгֵйؼҩҩѧٴƷӦϢһĿȺеϢԡ


ܹܶŻƺʵʩˮƽӶЧϻߺԴļʱɼԡ


ΪЩĽܶȣҪر׼ܻ֧ʱϿɶȴɹʶ⣬бҪչ뻼ߺҽרҵĶԻͬʱǿEMAԾ߶ӣҪ߼ıܹ֯͹̡EMAڴٽⲿרݹͺ淢á


ΪˣEMAж


̼ǿģƷڲƷȫڵӦãŷĿijɹ


ƶ˹ܣAIڽģͷʹõļָϺͱ׼


ʵݣRWDģƷĽչʹȺرDZӵĻȺ棻


ͨ෽ƽ̨ٽ׼Ŀ͹ʼЭ


عƣȷи㷺֪ʶ


ŷ˲ܿѧ׿Խģܻṩģͷ湤ѵо


ǿнģͷרҵ֪ʶⲿ/Լŷ򹲽Ŀ紴ҩжƻIMIƽ2020Ŀĺ


ΪضƷƶָϡ߹һ֣нģͷĿԣԽؼ⣻


̿ߺͨƶݱ׼ݽƽ̨ٽݹ


3.2.7ּ˹ܽо


ӸԴνĴݣݵٶԽԽ죬սͻǶ˹ܵ·µּʩܹרҵͷġĺҵݼṩϢȡ·ʽEMAƻЩͼ߹ЧʲΪܾṩϢΪЩĽܶȣƶָԭԶ漰˽͸ȡȨŶȺͿƷԹ淶ԵҪˡ


Ƕ˹ּܺ·ҵչѸ٣ҩЩԴڳ׶ΣбҪʹ֪㹤ǿתΪмֵĿѧ۵ͻΪȷЩߺͼӦõЧԡԣҪͨѧƿѧҺͼѧ֮кͬŷίԱᡢŷ˺͹ʼܻҵHTAߡҽרҡѧ׼ȫڽЩ·͹ȫܿҪһӦþҪʵʩHMA-EMAϹȽ顣


Ϊھôݼ˹ܣEMA飺


̽һִʵң̽ͿҩܷΧḶ̌µּ˹֧Чʺ;ˮƽ


ͨݿѧּ˹ؽƷյ㼰ڼϵͳеӦйصĿγ֪̿ʶƻչļרҵ֪ʶ


̴άݿѧ˹ּ̳˹IJ߽ͬнּ̳ʹú˹Ӧ漰ļɡܺͿѧĹ۵㣻


̽רŵĿƶָԭͽ顣ÿӦȷЩָԭӦƶƶЩӰ죬Լɽָɹأ


Ŭͨ׼ܻFDAЩʵָ޶ȵȫһԣ


ִHMA-EMAϹڷȽ顣


3.3ĿҽƱϵͳٽԻΪĵҩɼ


ߺҽƻӦΪϵͳжģˣһսһҪսĿǴٽҩƷĿɼԡĿȷܹʱȡɸġҽҩƷȷҽƱв߶ܻȡȷʹϢ


⽫ҪEMAпܻϣ߾ۼһرҪߺҽרұڡҪչȷʵݻ㷺ġݡܹHTA֧ڵߵͬʱһĿʵ֡


Ӧ⣬ҩijɹһٽҩĿɼԡ⣬Ϊȷ߶ܹȡҩ֪EMAҪһĹͨߺҽרṩӲƷϢ


3.3.1HTAԴҩ׼ξ


ҩĿɼԲȡڼܾ飺ŷҽϵУHTA֧ھҩƷʹúͻȡҲŹؼáȻΪ˴ٽ߶ԴҩĿɼԣЩؼɫ໥ְͬʱҪиеĺҲߺҽרҵIJ롣˵ֺʹҽϵͳΪºͼļ׼


EMAѾȡһЩжƻͼȷҩзɵ֤кھߵҪЩҪһչص۽ҩƷ֤ɹ滮֤Ҫڼӿ컼߶ҩĿɼԡͨHTA߽Ӵܻȷƶµı׼ָϣѧͼչҪ趨ȷ⽫ָԴ䡣һЧŷһܿ򡢱ظ̾ʱ䲢ùں͸˵ͲԴ


ΪˣEMAȡж


ȷHTA֧Ҫ֤ѱǰڵҩзƻаҩ֤ɣ


HTAϢִ֧ҩ-Ȩ⵽Ч֮Žӣ


HTA֤ɺָԭͷ


HTAȷȲƷͼ


ͨƷľ߲Ӱ죻


ظְΧڣһչEMAHTAĽṹԻ


3.3.2֧ͨЭʵִɼŽ


ҩҽϵҪܻʹҩɣҽϵҲܻᵼ»ӳٻ޷øҩˣܻ֧֮ȻҪϢ


ʶܻ֧ڸԵְ;߱׼ͬҪءжҩļֵҪѭܹ涨ȴǻضҽƻȻȻһЩԴغͳֵIJ档


Ϊֹ˫ĻЩƬŷ˵֧ģʽǧˣϣһһĿչԻƽ̨⽫̽ӽɨķ˽δԴĹؼͬʱHTA֤ۣߵĿʹһ֤ɼƻܹռϢ˽ҩδ֤ҪһرҪĹͬҪǣܻӦʸijҩƵȺĻΪʸƵȺģܻ֧߲شӰ졣


ΪʵִɼԸƽȵĹɣEMAжԼǿ֧ĺ


ʹ֧Ҫܹ뵽֤ɼƻԤУа֤ɣ


ͨӽɨѰᣬҽϵͳǰ׼


EMA֧֮佨ӽṹĻظְ£֧Ϣ


ߺвƷܣȫԺЧԣм⣨ѧϰҽƱϵͳͨչƻRMPӵ֤ݹ滮


3.3.3ǿ֤еĻ


߽ǵľ顢ʶרҵ֪ʶҩͼܾӰĿѧСEMAߵᴩҩڣӳ˸ûԴӶȡ


EMAѰԸ÷нһĽԱϵͳķʽӸ㷺ĻȺȡϢµֹߺͻ߱ѧҲ˻EMAʼֻ߱PROsҩ﹦ܡ״̬Ƶı棩ΪҩƷύеٴյ㡣ǵƣӽ׼ҽƺͻڽҽȵķչݵӦÿܻᱻһǿEMAܿѧս˵˽ػɡʹýԵΪؼ


޶еĻ߲뷽͸EMAеġ뻼ߺͻ֯ĿܡԷӳEMAϸĽĶԻݵĴʽͶԻ߲EMAѧίԱṤIJǿ


̽Ͳռʹûݽл-


̸еIJƶµEMAռָϣ


Эȡ߱PROsķ


̴ٽĽصĹPROsʹá


3.3.4ƽʵݣRWDھеӦ


ĿǰʵݵӦҪҩƷ׶ΣҩƷڣʵеõһӦõĻᣬ԰ӦٴijЩԡEMAʶٴȷƷձȷĸҪԣȻƷʹRWDɲ֤ݷ棬DZڵĻд


Ҫһǣ RWDԸ̸ֵһϣ֮ӦһԴԣһķвѧһоԲ֤ݡ⣬ݵİȫҲõϣعģʽȷЩ


Ϊھ߹ƹʹøRWDEMAȡжУ


̱ܿѧսRWDصжڽ3.3.5г10жС⣬չRWDԵ㹤ҩᆵع


չʹʵݣӽ¼пٷԵ㹤֧ҩᆵίԱᣨPRACҩƷίԱᣨCHMPľߣ


ʹõӽ¼ҩƷȫ⣨ҩ໥ãЧ


ṩҩзͬ׶ʹRWDʵϢƶʹõָϡ


3.3.5չרҺԴ


Ѹٷչճٴѧоճлȡ˴ҽݡΪṩ˸ȫ˽⻼ߺͼǰõЩµԴԲµ֤ݣпܴĽҩƷڵĻ-յʽ


ȻܻҪרҺ˽Щݣ˽ݵijַʽͷʽƶ׼ָ֤ϣȷ㹻ȽڼܾߡΪȡߵΣݱһµġ˽İȫҪ


EMAܿѧսԲοHMA-EMAϹ2020120շĽ顣ˣΪַ֧չҪEMAȡж


ṩһɳƽ̨Էʺͷŷ˵ҽݣʵݷѯ-DARWIN߽ҵѰԽάһȫŷƽ̨ͨṩҽϵͳָ֤֧õҩƷߣ


̽ŷݵԿܡƶָ룬ͨѧѯǿ֤̣ٽԱܵӽ¼עǼݡѧݣٽݵĿɼԣ


ȷݵĿɷԡԴѡУΪܾȷؼԪݣĽENCePPԴݿ⣬ԱʶݣٽFAIRFindable, Accessible, Interoperable, Reusable ɲҡɷƽߢɽͿãԭӦã


̿ŷ˼йؼܡڼ缼ܷĻϣƶѵγ̺սԣѧڵⲿרҺƸݿѧҡѧרҡͳѧרҡвѧԼ߼˹רң


̼ǿŷύĴݵĴѧϰжƻٰݵύݲԽ飬жƻѧϰɹƶ˼ļָϡǿеҩƷкоPASעǼǣо͸ȣ


̽ŷݵա洢ͷݼ߲PLDļܻķ磻ǿŷ֤˹㷨


ʵרݵִйܹĻϣһѧо飬ùͳѧģͷ桢Ʒҩѧʵݡвѧ͸߼ѧרңһҩѧϲǿġѧ飻


ȷڰȫġµĿڶݽйͷʵʩŷݱйжƻͨṩݱ뻼ߺҽרҾݹнӴѯίԱ᣻


йعʳ֧ڹʶ̳ƶ׼ͨ׼ʵʩݱ׼սԣʺ˫ߺͷ


̴ŷ˴ݡʵʩ̳ŷҪߵĶԻаߡҽרҡҵHTA֧ҽеܻͼ˾ڸص㹵ͨ㣬ڼܺʹݷصϢ͹ͨϵԴ


3.3.6ԵӸʽǿIJƷϢePI


бҪĽҩϢݸߺҽרҵķʽ20173£ŷίԱŷҩƷƷϢеȱݣƷЧ顢Ʒװ˵ͱǩύһݱ棬ŷίԱĴۣ֮EMAƶһжƻԸŷ˲ƷϢüƻҪһ̽ʹõӸʽƻߺҽרҶҩƷϢĿɼԡ⽫ʹҩƷȫԡЧԵĹؼϢܹʵֿٸ£ʹƹеĺʱܹסٵػȷϢӶǵľõƽƽ̡


EMAƶжƻ޸ŷָϺģж߰װ˵Ϳɶԣٽ߲԰װ˵ĿͲԣƹͽʵؼϢֵDZܡ


ǵEMAҩƷܻŷίԱ2019̶ġŷҩӲƷϢؼԭ򡱣EMAӦʵʩͽһչʵʱӲƷϢعƷϢĿɶԡ߲ͲƷϢйصĹҲӦüƽΪʵһĿ꣬EMA߱磬ж


̾ͲƷЧͻ˵ʵʵʱ


ҽƷṩߡߺҩҵһƶսԼƻṩһɳIJƷϢePIϵͳ


ͨԴͱ׼ķʽӿڣʹܹظʹýṹҩƷϢ


ŷ˱ָĸĽƷϢPIݵƷװ˵IJֺͿɶԼûԣ


ƶ滮ʵӽϵͳԶϢƻĽͻԣȷݵĿֲԣ


̽ҩƷϢֻŷĹؼ⣬ڱҩƷȱԼҩƷӦжƻ


3.3.7ٽҽϵͳҩӦüܶ


ҩһҩѱŷ׼һҩαҩ߶ơͨԭҩľҩŷʹҩøɸӶؿ˻ʹҩƵŷҩܺߣļܻⷽרҵ֪ʶEMAչһ֪ʶ⣬ȷŷ˹ܹøȫЧҩƷ


ȥǶҩʺͼܷʽȱ˽⣬ⱻΪһ̶ϵ˶ʹõIJΡEMAѾҽרҺͻߺԸõؽЩҩзͼܱĿѧŷԸרҵ֪ʶпõһչ


Ϊ˴ﵽһĿģEMA飺


̽һƽҽƱṩߺͻ֯սԹͨǿκģ


̼ǿԷŷ˼ܻҩѵչ


Ӧҵļս磬ڲαͶԴƷ/ҩݱУҩƷĹؼԣCQAͳ


̽һҩܣʹҩзٴӦйƶ۵¿ѧ֪ʶ


3.3.8һٽⲿ͹ͨŷ˼ϵκ


EMAԳһֱ뻼ߺҽרҽӴⲿߵĶԻEMAΪһְܻ˵ȻҪܹһǿ乤͸ȡͬʱEMAĹ͸ȺϢӦýƽ̨ͨѶߵķչֽһһ


߽Ӵ͹ͨʱEMAѭ͸ɺ˲ԡʵ㷺ԡЧͨͳĽԭΪʵЩĿ꣬ʵȷһԣоȷ䷽֤ΪߵϢ


ΪˣEMA£


ƶؼͼܿѧȵ㻰ݲԣ


ͨѧͻչרҵӣ


йߺƹͨ򹫹ؼ磩


ƻߡҽרҺߣHTA֧Ĺͨ


ͨݺ͸ʽƽչԺͻ֤ݵĽ


оŻչͨԸı仼ߺҽרΪӰ죬漰չҩᆵһ֡


3.4ĿģӦ³ֵĽвƿɼԷս


EMAʹǴٽҩƷۺͼܷĿѧչʹŷ˵ĹںͶ。л档ˣǵĸĿĹĿȷϵܹЧӦҩƷͿɼԣӦк³ֵĽв


Ϊ֧һĿ꣬EMAڼ˽顣EMAù滮׼֧ӦԹвȫŬֿ֧µĿغӦԿҩԡ֧зͼĴ·ָ֧ƹͨͽڶ˽εйؾٴ롣


һҪҩƷδлӦжµŷҩƷӦ⡣ҩƷӦкܶԭһȫ⣬ˣҪͬϵĺ漰ߺ͹ʺ顣һصǣѻġضӦ֢ļҩоȷǷӦ֢пܼҩзʱͳɱΪṩѡ񡣴⣬ͨ/֤ӷҩοҩ׼ЧԣҲܹٽϵͼ۸ҩĹӦĽ¡


3.4.1ִEMAĽвƻȦԴĽ׼


EMAŷеЭãƶһĽвƻרŵļܿѧѯѾֿ֧١ЧؿͼӦһϵ³ֵĽвҩصԴӴеκĿǰδȷIJԭ壨νġXвŷ˻ʵʩоԴٽȾĴģٴоʺ硢ȹ߿͵칤ա


ڹڰկǰ͹״COVID-19ľټ֮ǰдкMERS/SARSı˹ʺԼڲ֮ϵ͹ͨҪԡв϶DZڼ䣬ˡ׼бҪѧ֤ݣʹƷļв֮ǰ⣬ҪȷȦԴȷҪʱܹѸЧִмƻеж


ˣEMAȡж


̼ǿŷڿѧͼܻЭ


³ֲԭ͡X׼


̽һ˽¼Ӧ³ֵĽвãȷʵļֺ֧ͼල


ŷ˼ܻЭٴļܿܣڽ£


ǿʺҽҩƷзкټⷽĺ


ܺ顢ҽרҺ͹ڽЧʱĹͨ


ƶͼҩãѻƬƼķҩᆵ䣩


3.4.2֧µĿؼĿ


Ϊһһ֣ϸȾͿغҩƷDZҩԶԿӵĿҩԡĿǰEMA޸ṩҩзָϡּЭҪĹʺҩֻƶһзƻӦֽ֧ٴ磬ԴٽͿصзͬҪУHTA֧ȷҩ֤ҪҲǵҪ


EMAּ֧ΪҩзµҵģʽͼʩĿδĿصĿͻϣȷصõȷʹá


EMAж


̹µҵģʽЩҵģʽŷĿǰоս֮⣬ṩͼͬķԣаµĺԭеĿعӦĽڼƻ


HTA֧ȷ¿ҩ֤Ҫ


̸Ľָϣ֧¿ҩзԼԤƸȾĴ·


ֿ֧ϹߵĿӦã


֧ٴжƻƶͼٴ


3.4.3ٽȫԤͽӦ


ŷҩƷӦǼܵ֡ߺ塢ҽƱṩߺҩҵ൱עһ⡣ҩƷӦ㲻ڻ/вƷĹӦжϣ⣩漰ҩƷδ׼򱻳أԼƷδٽг⣬֤ͨ¹֤ӷҩο׼ЧԣӶӽϵͼ۸ҩĹӦ


ˣҩƷԭǸӵģҩƷз͹ӦȫԣʺԽЩҪΪ˽һٽһ㣬EMA飺


HMA/EMAҩ﹩ӦĹƻϣǿɹ


̽ŷ޺͹ʲܵĻƣرԻҩ


̼ǿʼܻ⵼µҩƷӦжϷĺ


̴ٽ߾/ҩƷȱи㷺֪ʶ


̼߽ӴӦҩƷȱԭͺ


ָ֧ӷҩܿѧ׼ĹЭԽЧԡͽģ⣻


̼ǿҩƷȱļ⣬ǿŷ˹ҽרңHCPڹӦϵĹͨ


3.4.4֧зкĴ·


ǹ߳ɱЧ桢ɹĸԤʩ֮һз͹ӦضļսĸԣҪ̽µĹߺͷȷԡͬҪŵٴԼ߷Ӧ߱߼ⶨĸо缼ҩ;ijֽʹл档


ܻ͹֮ӦýиΪۺϵĶԻԱõΪзֵܵľṩϢ⣬簲ȫкЧԼƽ̨Ľʹܻ͹ĹлĶࡣܻߡ㷺ĹṩйȫԺЧԼͼⷽʽϢҲŹؼãĿǰڽκͿ˷ԥͬⷽҪ빫


ΪˣEMAж


̽ŷк-ռƽ̨


û֤ݵĹߣؼ߾ͻ-սйͨԿ˷ԥ


оٴ鷽ӿ翪


̷չ߷Ӧķ/ߣֶ֧Խж壻


̻¼ٽԸϵͳĿ


빫ֺ͹߼ѯС飨NITAGõΪṩϢ


̽һ˽¼ƽ̨Ӧ³ֵĽвãȷʵļֺ֧ͼල


Эٴļܿܣڽ£


3.4.5֧֡ҩáܵƶʵʩ


ҽѧоԽԽؼ̽νѱijּҩ⵼ŷ޲ͨ߰ȫʱҩSTAMPרίԱС顱EMAԱ֮һ һϵۡЩڶӦóרҩѰµӦ֢ӶҩδΪṩѡ񣬲ɵ֤ݼҩзʱͳɱٽҽϵͳĿɳԡ


֧֡ҩáҪǼݣDZڵļأ֧ȷ;֤ԴѧͷӪ֯֯IJ룻ɺͷרʹýӦ޸ġֻڸʽĿڿչ෽ߵۣDzܵʵ֡


Ϊ֧֡ҩáܵĿʵʩEMA飺


̼ǿ֤ɺ루MAAĿѧͼѯ


ƶڵݿ⡢RWDʷٴݼķѧԭ


̶EMAעǼԵ㹤ľתָʵݣRWDռ


ֵ̽͸Ԥٴ֤еӦá


3.5 Ŀ壺ֺ֧üܿѧеоʹ


ûĵĿǽһǿŷ˼ѧ֮еĻԱʱ˽صĿѧºоȷӦսķʵָսսĿͽĹؼ


ԤһĿ꽫ͨѧоĺһµļܿѧʹƽ̨ʵ֡ռĿȷܿѧʼմǰأԱEMAܹ䱣Ͷ。ԼٽҩƷɼԵĻʹ


3.5.1ѧ/оķչĻϵչܿѧսо


ŷѧоʵۺд󲿷оҩзйءΪǿӰѧҺͼܻ֮һĶԻҪǵһ㣬ܻо֮佫ΪڵġϵԱڼܿѧijЩоչϵ


һٴĿΪоĵĿѧṩһֻƣͬЭȷʹҪо⡣ֺȷŷȡЭһµӶʹܾߺܹ֤Ϊ򲢱һ¡


EMAȡж


ƶʵʩһ·ͼȷѧںδκΪǿҩҩϵRSSסӦĻϣõ֧ѧҩзͬʱȷսԡսͲ滥ʵʾٴ룻


оѧйصЭ̣ȷ뻼صļܿѧսĻоѵ/⣨综߱ѧϡŴѧҩеϲƷģͷ桢ݺ˹ܣ


̻ŷо봴ܾ֣DG Research & InnovationŷʳƷȫDG-SANTEŷͨ硢ݺͼDG CONNECT½жƻŷỷʳƷȫίԱᣨENVIͳԱнǢ鲢о


̽һҩᆵͷչ滮Ӱ쿪չо


ҩƷкȫоʵʩӰ죻


ԱǩӰͶԶڰȫ±йشƷЧã


ԲͬҩﲻӦӰ죨ԷķزӦͻ߱棩Ż°ȫļ⣻


СʩҪж֮ӰооӦͶַ


3.5.2ѧѧ֮ĺٳֵļܿѧо


ܿѧĺһƽ̨ƽ̨ҲڼʱӦҪ¼򹤾ߵ˴¡


һĿüѧҺѧ̽ġϷչļⷽкԱ㿪ӦԵļܺ͹ߡΪʹһĿΪܣEMAҪԴ


Ϊѧͼѧ֮ĺٳֵļܿѧо⣬EMAȡж


ṩʽԽٳֵļܿѧо⣻


ȷĿѧҡѧѧ֮лͨӦоתΪҩͼܹߣʵӰ죻


ͨЩӦĿܿѧְҵоԱѵ磬ͨ䰲ڼѵ


ΪEMAңHMAEU-INȫ򣨹ҩƷܻICMRAܻĺսԣһŽжƻЩ֮ĵͻ롣


3.5.3ʶͻȡŷ޺͹רҵ֪ʶ


ǣκĶרΪʻݽˡߡڿͬԼҵʵǷdzߵġܻҲҪˮƽרҵ֪ʶſѧѧԽԽϸζҪ˵ļ֪ܺʶ


ѧ֮ĻϵȻҲҪڼܿѧؼѰŵĹרҵ֪ʶˣͨͻȡʵĴʽٽרҵ֪ʶĿɼԣԱڼܻϤרҵĴѯ


Ϊִ飬EMAȡж


̽Ӫ조һ£ߣߡҩӣߡܻѧµļ;飻


̶ںٽ롰ŷ޲ο硱ĺһȷҪԴĿĺƻ


һܣܳʶרҲʹУͬʱȷϸͻߣ


̿һ֪ʶϵͳԸٴ¡ϢϵڲƷ¼⡣


3.5.4缰ƹͽרҵ֪ʶܺʹµ


֪ʶĿŽǿѧĻҲǷչĶͨѧоרҵ֪ʶ֮кֽΪ˫Ҫ档


ЩɼܿѧġӦҽѧѧпѧϰϣ⽫1ڼѵҪ2ͬʱоѧͿѧҵ֪ʶӶѧƶٴоijɹͳɹ3ؿѧרҵרҵѵƺоУǿ֪ʶҩзͼܿѧ


Ϊִ飬EMAȡж


ѧѵģ飬ҩ¼ʵҵߵĹ


ŷҩƷ磨EMRN


ȷѵѧϰĿ֮IJࣻ


ѧṩѵģγ̣


ͨѧŷ˴͹ҩƷܻˣICMRAĺڹؼӽɨ裻


ƶݹĻٽ߶Ŀſѧ


ġҩܿѧĸսĿ꣨ԣ


塢ͬЭʼܿѧ


ŷļܻչǸսĴ󲿷ԸĹؼֺҩ﹩Ӧзרҵ֪ʶȫġӦԴ´Ĺͬս濪չʺͨϽ⡢Դ㼯Լܹߡ׼ͬЩ⡣EMAڼڹľζȫڽ໥κͿչ淢쵼áܶߺȷʵҪԴԸٽκܻĹǶЧʹԴһͶƽߣ


رΪʵҩƷӦݵԣEMAҩڵĶѰݺЭ׼ҩƷ淶GMPٴ淶GCPٴ鴴¡ѧѯҩᆵ䡣GMP/GCPĺdzϱ˴˵ļݣؼܲŲ飬໥˽⡢ǿ衣һҪڹҩƷ֤֯PIC/SʳƷҩƷܾ֣FDAձͶƽҽҩƷҽеۺϻMHLW/PMDAô֯WHO֮еģͬʱҲҩҩĺܶչ


⣬ͨʹWHOͷŷ˼ܻУEMAڹʷΧڽ衣磬֧ѵӦ紫ȾҩƷȱҩԣAMRȹضжƻּȷһЩؼ⣨޸ݵĿֻŵȣϵЭͨ


EMAڸжƻм֧һһĹԱȫȨݡŷȫҽҩEU-M4all58еңLMICҩƷίԱᣨCHMPôҩӰȫ90138ҩEMA֯NGOȵķǴͳύ롣EMAЭע֧֣棬ԼӿеҵҩƷͨΪEMA֧ʵ͹ʱ׼ĸʹáνʹûڿѧķӦ³ֵļսҩƷȱҩԺʹȾ


ˣEMAʺصӽɨͻڿѧĴ¡սпǵļⶼͬЩսܻйأӦԺӦЩս˫ġӦͨĿǰڼܻ俪ŵʵ֣ЩICHICMRAICDRAȸ߼̳ҲEMAȺȸרҵص


ҩ򣬹ʺҪͨCODEXOIEVICHȼȶ̳̳Сֽ̽һҩˡEMA֧һ۵㣬һΪѵսҩƷܴ档

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