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ƽҩƷܿѧǵҩƷܻʵҩƷִشսѡƽҩƷܿѧչУƶҩƷܿѧսԣȫֺսϹ滮ҩƷܿѧչĿꡢصͷȡ201010£񲿣HHSʳƷҩƷ֣FDAϷƽļܿѧFDAܿѧжƻܡÿܷΪ֣һִժҪǼܿѧǰǺʵʩܡļƽʳƷҩƷܿѧͷƹڽDZĹǰΪӿƶҹҩƷܿѧо뿪չֽƽļܿѧο


ƽļܿѧ

ѡ

   



1.ܿѧָFDAܲƷİȫԡЧԡܵ¹ߡ±׼·Ŀѧ


Regulatory science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.


2.ûһ֡ûӵܽǶصִѧսһȷģҪǽٵȵĹ⣬Ҫµķµĺµķʽ21͵ļھҪǡ


There is no single discovery no magic bullet to address our unique set of modern scientific regulatory challenges. But one thing is clear: if we are to solve the most pressing public health problems we face today, we need new approaches, new collaborations and new ways to take advantage of 21st century technologies. And we need them now.


3. ܿѧĽЧʣṩȫ²ƷǿƷʹúܵӶ߻ߵЧ


Advances in regulatory science will help make the evaluation and approval process more efficient, helping to deliver safe new products to patients faster and strengthening the ability to monitor product use and improve performance, thus enhancing patient outcomes.


4. ûмܿѧĽϣҽƷܾͻΪȱʶDZĹ߶зб߹ʱܲҪƳ׼෴ĽǮʱܱ˷һ֤֮ȫЧµƷϡ


Without advances in regulatory science, promising medical therapies may be discarded during the developmental process simply because we lack the tools to recognize their potential, or outdated evaluation methods may unnecessarily delay their approval. Conversely, countless dollars and years may be wasted assessing a novel therapy that is later shown to be unsafe or ineffective.


5ܿѧĽչԱ֤õԽͿɱ


Advances in regulatory science will not only ensure better quality, but could also lower development and manufacturing costs.


ִժҪ



ѧͻơ׼ҽҩ²ƷеӦýչDZıԤϺƼЩչƲԳԸƻ߸ԻķչӶڽǰȫյͬʱ޶ȵЧ档ͬأоϢĽʹܹЧʶ΢ﲡԭ壬ʳƷȾıȷʳƷFDAܵIJƷԺδ䣬˭ʹáͨƶȫ߲ԣЩԤУ³ֵвʱҲܷҪá


ΪʹЩƼַDZΪܻʳƷҩƷ֣FDA뷢ҪãȷȫЧIJƷҪٽڽӻزµƷ͸ԤʩΪĿѧоҵǻʹǵִȷ²ƷڻҪʱܹʹЩµĿѧߡͷͨ21͹γdz֮ΪļܿѧܿѧָFDAܲƷİȫԡЧԡܵ¹ߡ׼ͷĿѧ


ļƽܿѧƹDZĹǰFDAڻڲȫΧڼǿһá


ļɣ(1) ܿѧǰ(2) Эͬʵʩܡһֽ˼ܿѧ˺ͳϣıԼǰʵȻ̽߸ͬĹЩĽ԰ṩáȫߴԵIJƷڶһսԿܣָFDAȫΧŬƽܿѧDZFDAĻʹٽͱڽ


жƻ


FDAڹؼ·жƻĿɹĻϣͨµļܿѧжƻƶܿѧķչ


жƻΪһIJɵĿ֧֣ڱļһиϸĸ


1.ֿ֧ѧʹµ쵼ЭսԹ滮͸ȣ


2.֧FDAڲЭչĹؼӦо


3.ֿ֧ѧ׿Խְҵչѧϰ֯


4.Ƹסܳѧҡ


ͳ20112500ԪԤ룬FDAƻڻŬȫѧ硢ҵĻϵһרŸܿѧ°칫ҽ쵼FDAڲսԷչЭڵĹƸؼԱͽ߲쵼


2011꣬󲿷Ԥ㽫ڶԱⲿͻϵ֧Ĵܿѧоо


1.Ϊ߸ıƷߴ綾ѧִķ廯ҩƷ־ϸжƻµҩ׼


2.ӦFDAܲƷе˼Ŀѧ׼ͼµĶ\Ʒר֪ʶ


3.ɹϢѧҽеעݷĿѧ㣻


4.δĹӪ빫


2011ĻΪܿѧ׿ԽFDAڲоٴоϵ춨ⲿĿǾԵģԵͿоγ׿Խġ


ļϸ˼ܿѧĽμӿFDA߶ȵĹĽչ


ûһ֡ûӵܽǶصִѧսһȷģҪǽٵȵĹ⣬Ҫµķµĺµķʽ21͵ļھҪǡ


ܿѧǰ


ʲôǼܿѧ


ܿѧָFDAܲƷİȫԡЧԡܵ¹ߡ±׼·Ŀѧ


ܿѧDZʲô


ܿѧ򡪰¹֪ʶ͹߱DZƶ뽡йصĹ㷺漰ּ磬һ̽Ԥܹı鵰׺͵¡õ߷ӦĿֳܹ방֢ʪؽ׺ƵԡЩов֪ʶʳƷԼҽƲƷжܵõܺõӦã԰õȷҩİȫЧ


ܿѧʵҡѧߡϢռԼݡԱϵͳȺоķϵͳΪﵽЧܿѧĽϵƷСԤڿе·ֺͼʧܻ߳ɹͲƷɱЭŬDzɻȱġܿѧĽЧʣṩȫ²ƷǿƷʹúܵӶ߻ߵЧ


ܿѧʲô


ͨ趨ص̺ԵͲԴͶʣFDAıƷоĻͿѧΪһעµĴ


¼ҳ˵ܿѧӦԵٵһЩҪȵĹսĿǰδ


I.  ṩµҽƷ


II. ƶƺͶͯ


III.ֹ³ֵĴȾͿֲ壻


IV. ͨϢѧǿȫͽ


V.  ʳ﹩Ӧ


VI. ƽȫԵִ


VII.Ӧ̲ݼܵս


һṩµҽƷ


ҽѧоͶʼչǶѧͼ⡣ȻƷĿڼ٣гɱȴ֮DZÿһĽҽƱЧԺЧӦ\ҵʵʹٵвȷõҽƷʱṩߡ


FDAʲô


ڹؼ·жƻĿijɹFDAĿѧһЩּ߻ֵʵüֵļܿѧɾзҪáΪȷ߻þ˵ҽƷͨԴĿѧҵķḻ֪ʶFDAѽԼȷΪҽģʽһɻȱIJ֡ᵽһЩɾͰ


̸ϸԼ


ѧҺFDAĿѧҿһַʶ𡰸ϸĻ־Ҳ˵ɸϸϵķ̶ֻȡѧҿ鷽ͱ׼ȷͬ͸ϸĴڡЩڿȷδֻĸϸܻӸϸƵķգȾʹõյġ̶ֻȸߵĸϸƷ


̰֢ĸԻ


20103ġI-SPY 2顱,һͻԵٴģʽѧҿЧزԳзеԿٰ߷ŮԵϣҩУʹضĻѧǣνġ־ÿŮѧϼ֣ӶԵطֱʹзеҩͨӦôµƣоԱʹһ黼ߵߣЧƺҩI-SPY 2־˵֧½еģһصĹ˽ϵFDAоԺʹҩ˾ɹоԺ쵼


FDAڼܿѧͶʲô


Ȼѧķչо޴DZƷķȻӡFDAĶѧίԱ֣ᷢ˵ΣСΪ


Ȼҩ﷢ֺз緢˸Եı仯ϸӺͻ򷽷ת䡪FDAڹȥлֲ䡣[ FDAѧίԱᣬFDAѧʹΣѧ뼼ίԱᱨ棬200711£http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20 Report%20on%20Science%20and%20Technology.pdf]


ûмܿѧĽϣҽƷܾͻΪȱʶDZĹ߶зб߹ʱܲҪƳ׼෴ĽǮʱܱ˷һ֤֮ȫЧµƷϡ


żܿѧĴ½ǿȫı档ǿʵֲƷִ¹ߡ׼ģͺͻڿѧ·ߴӿٵٶȡЧƽߢԤԡFDAԲӰһЩ


̸ȫֹʹҩ


ŴֹʹҩúõȫвͬʱھʹеIJȴòֵơµʹõ;Ѿ֣԰ֹʹҩڿΪ˼ӿṩµƷǻҪָõʹģ͡ߣ˱ٴƣԴٽЧҩĿõĿԡ


̽˲硢ҩ


FDAֶ֧ԤϺƿҩԷνˣTBƷ˷ܵо˲磬Աˣߺ;ӡDZ뿪·ʶȷԤƺͱõı־Ӷܹ˲Ʒ硣ǻ뿪ܹ١׼ȷϽ˲飬Щȷ˲ʱijЩƲҩԵķ


̷ҩĸ


ҩռҴ70%࣬˵ΨһƷˣʹοƷרѾڣƷҲûͨõķҩƷܹ˷ijЩƷȷЧԷѣṩķҩƷƷɷƷijЩֲƷδϵͳյIJƷȷЧԷսDZǿоЧķȷЩƷЧԣӶʹߡɱ͵ķҩܹ㷺ػá


ִƷ


FDAڡԴơQbD洦ȵλܿѧʵֶҽƲƷ̵ͿƵִܿѧĽչԱ֤õԽͿɱFDAֵ֧о1ӹвϲϵؽ豸ʱͳɱ2ʹù̷PATͿ̣dzƷ⣻Լ3̸ı߲ƷıͳƷӦЩڿƸӵ̣ЧʣΪṩɿIJƷ⣬ʩģ黯һ豸ʹõ¼ճͽ¼ٲƷ


աFDAǿڹؼѧоͬʱҵѧ翪µܵĺϵڸıǵϹڵĽ


ƶƺͶͯ


ӲСˡжصĽͷӰǶʳƷҽƲƷķӦҽѧڶͯԼվڶͯǶȿƷϣǵרҵ֪ʶв࣬FDAļܿѧֲֺϾõǰܷѧͶͯоҽѧоĻԾ򣬵ЩתΪƷٴоΪЩоͯΪһغͶȺΪ˸ͯṩʵӪͰȫЧҩDZ˽Ӱ죬Լͯ³´лΪͼӰ췽кβͬ


FDAʲô


FDAһֱڽͯʹõҽѧƷ⿼ǡаоչͳɳӰƹӰͯĿѧFDAרעܹҩڶͯϵõĿѧоЩ⡣ͨϣرǡѶͯҩBPCA͡оƽPREAԼFDAⲿĿѧFDAѿչܶоҩԶͯáЩоѵ³350ҩƷǩĸı䣬Щעҩѧ졢ԼԶͯʹüǿȫϢʾIJƷһо£


̽ʹÿҩɱ


һЩڽܿҩƵ֢߱˵ɱ뷨ɱδ졣⵼ţҩܾһ֡áʹܹѭԼɱ嶯90еļоóۣʵϣҩȫɱķ֮ûϵȻ2003꣬Լݽ˷ҩܵ¶ͯɱδɱӡ2004FDAٿѯίԱFDAʼ8ҵռ12пҩƷݽе顣372ٴ飬99231ߣд󲿷δҵݣǰоûʹù


FDA㷺չĶάȶԱоóһЩҪķֺͽۡȣû֤ݱÿҩijȺɱӡȻозʱ25µijɱķӡоʹʶ뿹ҩصɱ뷨ʵʩصģ25µ˷ӣ25-65ûӰ죬65ϵij˿нɱյá⵼FDAҩƷǩָ˾ϢܽԶٴоݽʹ÷ߺ͸߼ͳЩݣһҪ־Ͳ


FDAڼܿѧͶʲô


ܿѧṩһֻ᣺ʹܹͯصѧһʶӦõƷѧУȷǵĶͯȫͽDZһһЩ


ȷҽƲƷȫ


FDAͨһЩĿʼص;ҩİȫжƻ򾲼ԶͯӤӰ졣ĿԶƺͶͯشӰ졪ҪĿ


   ȷǵʳƷӦ


ͯرܵʳԴԲԭֺһȣǸΪʳԴԼеFDAעܿѧҪǷչٺʵõķʶʳƷе΢ﲡԭװFDAʵͬʱʳƷеȾ⣬FDAǿʳԴԼԭĿѧʶԱƺʵʩеĸԤʩЧͷա


̷ֹͯ


֪ԶͯΪĿʱ̵ֹŬرЧݡͥԤ̲ݿƷȨFDA鲢ʵʩԶͯĹӪƣԼٿʼ̡FDAҪһʶҵӰ󣬴ӶӴֹǡЩж̿ʼӰ콫ȷFDAܹʵĿꡣ


̶Կ


17%20¶֣ͯʹѪܼ2򲡺ԼķաرFDAʳƷǩϵȨҪ߸֪ʳƷӪҪֶΡ°ͳǩҽķӪǩҪԶۻΪЧʹһȨFDAпѧȷʳƷǩѡõġ


˽ⶾصķ


ŷͳɳӤͶͯҪõʹڱ¶ʳҽƲƷǽӴƷΣռĶ¡FDAҶѧоʶЩأгϲƷԽӰķա


ŲƷṹԽԽӣFDAĿѧҲıӦЩս


ֹ³ֵĴȾͿֲ


Ⱦ޹硣ǵŴӴе²ԭ壨SARS״ȲӿֺȻֵµвͬʱDZʶһʵǵDzȶġˣǻܵѧ/˹DZΪDZв׼Ȼвв̿ҡ컨еһЩµĻ벻в⣬˲űҪԡԴȾȳϸеƷԽԽҩԣвйҵ


Ŀǰڿ硢ϷƷķʽѸٺͳȫ͹ڵҪЩҽƶԲߣMCMķչûгûѧ߲Ʒ棨Ŀѧ£Щ¿Ըı׼¶ȫ򽡿


FDAʲô


FDAһֱڼͿ緽һֱҪãÿ궼ÿһвֺ2009 H1N1д󱬷ڼ䣬һɹĹ˽ϵڴ¼ʱڿ׼˰ȫЧ硣ЩԼϸӣFDAڽеļܿѧļӡ


̷ֹѪҺӦܵȾ


޺ӲһӴļ֢״ȾաĤ׻׺/2002꣬4156޺ӲȾı2003귭һ࣬ﵽ9862֮𽥼ٵ2009720FDACDCҲֲͨѪֲ20029£ִ֤ʵҽϵͳŬƸȾDZˣFDACDCѪҺҵкѸӦѪҺȫвǿļܿѧı׼ԼŬ֧ȫΧѸʵʩ޺ӲѪҪȷȫѪҺӦȫֵֹܳѪȾ


FDAڼܿѧͶʲô


ԼܿѧļᶨͶƶӦԹвҽƶԲҪ硶ӦҽѧԲԣǿµļܿѧоͿѧʵӦãڼǿMCMܳ򣬴ӶMCM̡FDAȡһµжƻּڼǿҽƲƷرMCMsİȫԡЧԺĹߣʹǸЧͨӸ̡


ҪЩͶδĿѧ⣬Ϊ²Ʒгȱ߲ԤIJƷЧļ·ؼľǣ1ƷЧĸ÷Ŀ2Ѹٽδ֪в¼ĿԡгһЩFDAüܿѧڽķʽ


۲ƷЧ·


пȥƷʽǷܶԿµĻڳֵĴȾ߿ֲвΪҪƷʽʱвǺģDzڵġΨһеѡ񣬵༲ȱõĶģͣоڼԽУͨģޡˣҪܿѧ֤ĽԤģ͡


ܿѧֲ֧ƷЧʩʶ֤磬FDAѪѪƿζȵĶͽܣԤЧ׼ʱ꣬Ӷɵ̵һڴֲв³ֵIJԭҪȫȾԤЧĴ־ѪҺԡҽѧӰеķӦвáŬĽ֤µ־ԽͿɱĽͼӿ쿪ȫЧIJƷδĹ


̸ݵIJƷз


˽пʹڲʹòԭ£졢ȫDNAȲƷƺ鷽


ƽ̨ʹÿṩģDZ磬һЩڼڶǼµ硣ƽ̨ڷΧIJƷ磬ͬIJӡ塢DNA鵰ױϵͳΪзͬĻԤСߡSARS߷ν˵ȼǿĹԿӦϵļڿ塢ԭͺĸͨ


ֶ;ͲƷҪܿѧĽƷЧۡȫԺЧԵ·FDAָĺȷƷܹδ߽Ҫ


̸ĽЧۺͿ޾֤


ڽ¸ٲƷҪִٵļ֧ⷽ֡FDAڿʵʩ١ͨķԼ⡢ʶ͵΢ƷȾ߹Ҷ³ֵĴȾȻΪвĹ׼


߲ƷȶԵķ


ܿѧѰ߲Ʒڻ߱ҪصķЩҩҪġЩڽ¿Ҫģȫ򿹻ҪɱԼߡ


޵ЧͳƷ


ʵҿѧĽһͳѧҲѸٷչӸ޵ݼṩɿϢ·³ֵļڼҪ


֤ȫԺЧԵϸģͺͼģ


ԹлͨģԤƷȫԻЧԵԽƽʱԴܵ¸ȫԵƣڼû㹻ʱٴʱҪġ


µĻ


ڽڻϼҪӦ¼׼ҲԿڹҩԵļⷽ˾ͶܵõЧơ


µļͺ͸ҩʽ


µӦʱ˵һСΪ˸عӦʹòƷҪµIJƷͺ͸ҩʽϵͳʵʱҸҩ


̲Ʒܵʵʱ


ڽ£ƷЧԺͰȫԣҪӦϢߡȽͳѧͽھ򷽷Ϊ2009H1N1ּƻǰδеİȫϵͳʵʱһʵFDAӦڿһ³ֵĴȾϢѧݿ⣬ЩѪҺӦDZв


̼ǿ͹ͨ


Ϊṩ׼ȷ׶ϢǿڵģʹǵľԱԼĽҪƽͷչͨѧĽ


ġͨϢѧǿȫͽ


FDAӵ֪ٴݴ洢⣬ЩǹҩƼҽеİȫԡЧԺܵĶصġݣǰкݡЩݣȻйȺӦDZڰοЧӦȻûд𰸡FDAݿһЩ⣬Щ漰ƷвͬӦĻȺijһҩЩ˵İȫ̶DzһġȻȱ֯ͷЩ漰оĴݼȷʩߺԴ仰˵һϢмֵͼݣû߷Ĺߡ


FDAʲô


FDAһֱͶڱҪĻʩ֧ԵӷʽоݣڷݼĻڴһԱȽϺͷоĿѧ㻷ҪЭͱ׼ԱݱȽܹЧСFDAŬ벢ԵĿʼʹϵͳ뽡ϢHIT׼Щ׼ǿֵ֧ӽ¼ϵͳĹŬһ֣һ¡ȻһݺϢϻ۵FDA׷һϵͳͷźͷӴݴ洢ÿյ渴ӵݡ׼רƷǰкĽϢĻ֮һ


ٴݽ׼ЭᣨCDISC


1997꣬CDISCʼ25ɣFDAҩ˾Ӧ̵ĴЩ־ԸЭ֧ٴ׼ƶٴ߿ҵѧռͷݵƫ̻κһ߻֯Щ׼ʹøáЧİȫԺЧݷԼҪҩĸΪܡCDISCѷչΪһӵȫķӪ֯ƶ׼оݱģͣSDTMһFDAύӰȫݺٴݵı׼200911£FDASDTM汾3.1.2ύ


FDAڼܿѧͶʲô


FDA洢ĴݱתΪЭĸʽ֯һͬݿУԱܹѯͷԽؼ⡣ЩĿҪϢѧӲͶʣ׼ڹϵݿͿѧģ͡


˵λĹͬƽ̨ѧǿִʷԼÿFDAݡ磬ǿһ15ڰ̲ҩоЩҩЩЧԼʱЧʹôҽƼ¼лȡġڶڵİȫϢµĻ򺱼İȫաЩ͵ķͨһоȡľѵӦõһоǿ飬һṩڼƵķdzмֵϢԼԿɹʧܵĻƵǰδе⡣Щ⽫FDAҽѧҽƱ磬ʹҽܹFDAܲƷʹǵľ


õ˽⼲ȻʷضԤʩЧӦʹٴ²ƷӸЧݣͻߵijɱͷա෽ҪĽ


ʹҽʵʱذȫ


ҪչЭϵͳԽաӹͷFDAܵIJƷIJ¼ȫϢͬʱȷDZߵ˽ݿҪһŻⲿûͨŻɵؽύFDA֯ͷϵͳӦܹڱϵͳнڱϵͳڿУʹҽϢHMOsϵͳĵݣΪкƷİȫṩ⣩ҪͶʻȡҽƱصļݣԿһܹṩ׼ȷʵʱйزͬȺưȫԵϢϵͳҽƱպҽƲģCMSֺڼУͬҪԻʩͶʣ֧Щ໥ݿ⣬ٽݱ׼ƶƽڽ͵ݵĵύ


ھѧ


Ҫµ߽ͶʣҲҪͶЭĿٴ顢ҽƱѧоھݵ¼ͷЩЧܣͬʱΪFDAṩ˿ƶƷз׶ԻҩƷ֪ʶѧһЩص


ʵʩкȫϵͳѯϵͳݿ⣬ȷҩﰲȫԡ


PRISMɺ߰ȫ⣩ϵͳչƷ.


ȽϢѧģھõؼͷȫźš


ģ⽨ģӦڷͷչͨԣʶԻ߰ȫв-Ķ


ǿITʩ֧ԪҪĿѧͷҪļģ͡


Ӧٴģ⽨ģӦͱҶ˹ٴƷԴٽ²ƷĿ


ѧӦѧѧķ


ӦʵĻоͳƷ


ѧ硢ҵĻϵһƽҪɲ֡ЩŬ֮FDAܲƷٴƺͼµģʽ߻߻棬ʹFDAȫ21͡


塢ʳƷӦԣ


ȫִ


һѧҪ顣Ȼɱߡʱṩ෴ӦɿصĽˣڶԶĹĺأDZ뿪ȫؼ١Ľ顣Ҫ֤ԤⰲȫԺƷԷɿķѧ͹ѧĽı䶾ѧʽDZǣЩ¼ûеõֵоͲԡͶѧΣĸԱ


FDAʲô


FDAȫĻʯ֮һǹҶѧоģ为ִFDAؼͬ󡢹ؼ·תоΪܾߺͽFDAܲƷصķյ춨ѧĻоּDZжѧƷ΢ѧӰ죻ƶԵĸӻƣ֪ԱеĹؼѧ¼ԼĽ屩¶׸Ժͷյ


ʾFDAڵĸƷҲоŬµĹߺͱ׼ҩƷҽеİȫԡ


ٴǰо־


ҵǣµĺѡҩھͶʺڿʧܡڽоǰҩ↑оʶDZڵİȫҪһЩĶⷢڸࡢѪϵͳFDAŷҩƷ֣EMA쵼˼ЩѧͲҵѰٴǰģʶȨڼҩյԵ־FDAEMAϿһЩ־ûоƬʶ𵽵ġЩ־ṩһڶģм඾ԵķԲԣ봫ͳȣԺԡ⣬Щ־ܻΪомԵЧߡ


FDAڼܿѧͶʲô


ļܿѧͶּ֧¼رǣõķձ־ԸƶͷǶģͲ֮磬ϸоƬѧʹлѧݣӦչ붯ٴоľĿʹԤԱ־滻߸Ľ¶ʵ顣ڷݷͶʽṩ໯ѧƷԵҪϢЩҪµƽ̨ݿ⣬FDAѧҽѵԱʹúͽЩݡѧ硢ҵֵܵλĺҪ


ƽܿѧһغҪģͺͿܵļģϵͳڶѧеʹáϸϵģ֯ϸķչҪģԸõϸ¶󴥷DZڻƣҿøЧ͸߳ɱЧĶѧоȡеķ


ԽԽµĸӼ׼ӦҲҪµķʽͷõԤЩϵDZڶԡFDAܵIJƷʳƷҩƷDZĽģʽЧͨպͻ棬ֽ֧ȫļܾߣȨҪDZڽ


ߡӦ̲ݼܵսԣ


Эͬʵʩ


FDAѾһIJɵսԿܣڻڲȫΧ쵼ƽܿѧṩ档


ֿ֧ѧʹµ쵼ЭսԹ滮͸


֧FDAڲЭչĹؼӦо


ֿ֧ѧ׿Խְҵչѧϰ֯


Ƹסܳѧ


üƻÿһֶǿFDAѧٽҵѧĻգһƻ֯ġʵŬ֧ȫܿѧķչٽʳƷҽƲƷȫԷµġҪǴµķ


1.ֿ֧ѧ봴µ쵼ЭսԹ滮͸


ϯѧҰ칫ҽЭڲⲿȷܿѧʹµĹؼ󣬲ƶFDAѧսԼƻϯѧҰ칫ڣѧ봴°칫ҽƶսԼƻͶʵĽ֯ĵĿѧⲿϵ


ؼͶ뽫֯ṩ


̿ѧ봴սѯίԱ


ڲFDAһ߼ѯίԱᡣѯίԱԱϯѧҺ;ֳ칫ҡĺORAĸ߼쵼ѯίԱÿٿλ飬ȷĵĹؼѧȷۻҪѧҪĿͺϵЩͶ뽫ƶսԿѧƻ


FDAѧίԱ


FDAĿѧίԱѾλԾFDAĿѧĿԼҵѧĸӿѧͼ⣬ֳϯѧҺṩ顣ѧίԱὫҪͨѧ봴սѯίԱϯѧĿѧսԹ滮ͼܿѧĿ


2.֧FDAڲЭչĹؼӦо


FDAڲֶ֧ܿѧҪһFDAֱصĻоĿֱΪFDA顢ƷļܿѧչһΪܺߵƶӼֵ


⣬ܿѧѧƱͨϵⲿо֧չдĻǿFDAĿǰĿҲдῪµļƻ֧ЧⲿĺЭĹƽܿѧһЩĿѾڽУ


FDANIHһ쵼ίԱᣬͨǿѧֺ֧ͬ͹ܿѧⲿоѣٽܿѧչ


̴ּ֧ܿѧѧ׿ԽģFDAչܿѧӦоΪFDAѧѧṩѧѵᡣ


̼ǿսЭЭԿµĿٽܿѧʹ¡


̼ǿԹؼ·жƻֺ֧͹עͨҽƲƷ̵Ĵºִʹγƽܿѧ͹Ļϵ塣


ּ֧ܿѧĿϣڴὨϵ


3.ѧ׿Խְҵչѧϰ֯


FDA֧ǵĿԱгĿѧѧϰְҵչĻ衣FDA¼ַʽ


ͨѧȵλԼ֧ЩߺԴʹFDAԱü˵ļְҵչ


ѧԼʼܻ鿪չѧĿ


4.Ƹסѧ


FDAŬļסһ֧ʵҵСж飬µĺ˵ļֳĽѧƻѾʼѵļڿѧºĹؼǰ;ѧңĿŻFDAĻFDA


̰ļ֧˼ǰ;¶ѧҳΪFDAоԱļƻ


ĹԵгɾͺ͸гЧFDAѧң֧FDA


FDAרҽʦְּ֧ѧʦ/FDAְλʹڲ˻ļרҵ֪ʶͼ鷽ĸĽرǶ˼򣩡׵ͻɸѡ󣬲߽FDAȫְԱһչ߻


ַ֧չƽܿѧ԰ṩʵִǰĹߺ֪ʶЩŬֺϴӻѧֵߵİȫЧƷ֮ĺ蹵ͰȫҩƷʳƷİȫԣִ֧¡ЧҩƷ͹ڽ


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