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ڌ20256-7µćlGMPطָϽ˻ܣѡһЩԵķָϣՈġ
dļɲ鿴Ҏԭ朽ӣ
ȷҎָ
1. CFDI | ҩˮָϣ壩
lrg2025714 Ҋֹrg2025815
ָָּzT_չGMPԙzˎˮFz顣ȫ45퓣ԔˎˮLU|LUuˮˮעˮͼƂͷϵyšҪc͙zҪcKԔw˴_JcCճ\cSoBˮ|Oy|CBľSo/Cȡ
2. NMPA |ŻҩٴйĹ棨壩
lrg2025616 Ҋֹrg2025716
ԓּ䌍ԺkdPȫˎƷtеOܸĸMtˎbI|lչҊˎƷOֿYԇc̓ˎRԇuP헹£
һΪһ֧ٴֵΪĴҩзٴзЧԷҪĴҩٴՈ30
ҩٴՈ30ֹ֧ͨصзƷ֣ȫͬзʶٴ飬ٴҽҩҵչ
봴ҩٴ30ͨՈӦΪҩѧҩƷƷ1ഴҩܹҪύ걨ϣ֮һ һֵ֧cˎ@ȫ朗l֧քˎlչwϵֵ֧ľ@RrֵcˎƷN xˎƷOˎƷuăͯˎǹӋҊPӋƷN ȫͬаlƷNȫͬаlĢڡRԇIIIڇHRԇԼЇҪоߠ^_չćHRԇ
ġ30ͨҩٴՈҩƷලҩƷύ걨ϣ֤ѳֿҩٴ鳤λ顢ҪоͺϹύٴՈǰҩٴչͬչĿ飻߱걨ƷзӦƻڷŵڻ12ٴ飨ǩ֪ͬ飩
塢ˎRԇu{30ͨYҪɇˎƷOˎƷuƶl
봴ҩٴ30ͨՈٿרһȼԭ30ģҩƷලҩƷļʱ֪Ոˣʱް60ĬʾִС
3. NMPA |ҩƷՈУ壩
lrg2025708 Ҋֹrg2025807
ȬFа汾Ҋm×l{£Ҫӵ9헡
ڹ棬ϸՈǰĹͨՈύՈݣͬʱһḻՈоҩƷע֤עȷҪ
⣬˸ՈתΪķʽҲϸ˸вƷ걨ҪݣоʱǰӦʱ걨Ոύȷ֤о֤ڷգͨģՈ֪ͨ飬ҩƷע֤Чڡ
4. CDE |ѧҩƷҩѧָԭ壩
lrg2025609 Ҋֹrg2025709
ָԭּΪҩƷɳ/ԭҩǼǻҵͨʹPACMPʵʩѧԭҩƼкҩѧṩοҪݰPACMP ՈPACMP Ҫ PACMP ʵʩ PACMP ⶨо֤ʺύ PACMP ΡPACMP ΡPACMP ķֹȡ
5. CDE |ȽҩƷķΧ壨壩
lrg2025610 Ҋֹrg2025710
Ҋ塷ҪFA҇ˎƷаlFOrͼgָԭtӆMչƶ
ȽҩƷAdvanced therapy medicinal products,ATMPsָҩƷع涨ҩƷ·ơӪʹúͼܣҾڷԤڹܵϸҩƷҩƷԼϸ̵֯ȴ¼/ҩƷȽҩƷΪϸҩƷҩƷ࣬ÿһһΪϸ࣬о༰塣Ԥ硢ֹίҽƼһȽҩƷIJƷ
6. NMPA |ҽеעԼ涨ʵʩָϣ壩
lrg2025626 Ҋֹrg2025711
ָʵʩָҩƷܲŶԵڶࡢҽеչעԼʱֳ飬ҲΪעՈʵʩעԼ칤IJοݣעՈ˽ȫĿίʵҽеΡ
ʾעՈӦԼ칤ҽеϵйϡҽе淶¼ҪչעԼӦ߱ӦƷԼ䱸ƷҪӦļ豸ʩӦ鲿ŻרְԱϸ̿ƣȷʵȷͿݣԼ챨渺Ρ
ܣҩƷܲӦע걨ϱҪʱ֯չעԼ˲飬صעƷԼصԱ豸ͻʩƷơ¼ơϵҪݡ
7. NMPA |ҩƷҽеϢ涨壩
lrg2025731
Ҋ忂50lB؟ηֹl䰸Ϣ䰸ጏȷăݡ؟ηֹ棬ˎOؓ؟ָȫWˎƷtеϢՂ䰸ͱOʡˎOTؓ؟^ȻWˎƷtеϢյĂ䰸KMʩO⣬ƪԔUṩWˎƷtеϢյľWվƄӻWókλҪ؟xա
8. NMPA | ڶҩƷҽеȫڲeeʵʩĹ
lrg2025605
ԓmõĹˎƷtеơbIIʹÆλˎƷtеWjƽ̨ṩԼM½yQIPλăȲTP֪ˡ
ָˎƷtеơbIIʹÆλˎƷtеWjƽ̨ṩԼMăȲTP֪ˣˎƷOTeˎƷtе|ȫش`РˎƷOTʩ
9. NIFDC | ҩƷעԼ鹤ͼҪ淶 (2025)
lrg2025714 ʩrg2025801
淶ּڽһ淶ȫҩƷעԼ鹤Ч֧ҩƷ
ҎҪ£ 1. ǰעԼ鷶Χ ǰעԼ÷ΧՈչкՈرȣԤ̱2£ҩƷŻ
2. Ʒ ‌ҎˎƷ‌ÿƷ|ȫ헙z3{2 ‌ҩƷ‌עԼƷ39Ϊ12
3. ʱŻ ‌ҎˎƷ‌zrs10գ60յijҎrޣ ‌ȌuƷN‌zrs10 ‌R躱ҊˎƷ‌zrs20
4. Эͬ oܵČuczfͬCƣp}ύƷ_|`·С©µęz؆LU
10. CFDI |ҩٴָԭ
lrg2025620
ָԭtּMһˎRԇЧԇ|ˮƽ
Ҫ£
11. NMPA |ҽе֤涨ݰ壩
lrg2025702 Ҋֹrg202582
˴ӆݰĺ֧tеbƷQףҎˎƷOܲT߳NCķk
2015귢ġʳƷҩƷලֹܾڷҽеƷ֤涨ͨ桷201518ţͬǣδҹעԻ߱ҽеƷҪСҽе֤ͬՈҽе֤
ⷨҎָ 1. EC | Chapter 4: Documentation EC |£ļ¼
lrg202577 Ҋֹrg2025107
EUlӆGMPеһ¹ԭGMP/GDPzTMPIC/SίTͬhӆԷӳOܺbh׃ӆָ_˱OܙCļҪK]˸11P׃
2. EC | Annex 11: Computerised System EC | ¼11ϵͳ
lrg202577 ָϲݰּڑ׃ITh녷յďVԼGMPӋCϵy¼g룬ṩµıOָKMW˳ɆTcPIC/S֮gĽyһԓmˎƷͻ|bʹõĸNӋCϵy
3. EC | Annex 22: Artificial Intelligence EC |¼22˹ܡ
lrg202577
ԓȫݵģҲɠȫҪOܙClĵһᘌAIGMPļ
ָϲݰH6퓣o_ǶxЩAIܵOܡ
mˎƷͻ|bʹõĸNӋCϵyAIģڌ߰ȫbƷ|ɿֱӰ푵PIãAyᘌǶAIģ͵ӋCϵyṩˌ11aָ
4. FDA | Q1 Stability Testing of Drug Substances and Drug Products FDA | Q1 ԭҩҩƷȶԲ
lrg2025623
ָϲݰҩƷҪЭ» ICH ±дġָϲݰԭҩҩƷȶԤڣ֧ҩƷУՈҩļãָϲݰ ICH Q1AR2Q1BQ1CQ1DQ1E Q5C ϵȶָϵĺϲ棬ֱ 2003 11 ¡1996 3 ¡1997 5 ¡2003 1 ¡2004 6 º 1996 7 ·滹ΪƷࣨȽƷҩƷƷȶָ֮ǰδǵƷṩȶָϡָϲݰּṩһֹͳһķչͳԭҩҩƷȶԲݣṩڿѧǺݵԶġѧķ
5. PMDA | GMP / GCTP Annual Report PMDA |2024GMP/GCTPȱ桷
lrg202577
ԓԔYPMDA^ȥһЌˎƷb|ҎGMPͽMbƷb|ҎGCTPıOܹɹ߀SһݵȱΣӋ43ȱݡ
2024꣬PMDAȫ깲ʩ131GMP/GCTPؙz飨{ˡ2,062z飬Լ590Oʩz46ͻz飨ʖˡ⣬PMDA߀̎34IԃKl6ɫţM3GMPAhԴMИIȵĽ͆}Q
gӭԃ ՟ᾀ400-166-2002
Pgempex¶ԃ ¶ԃgempexЇȫYӹ˾ǾЇHӰGMPԃcЙCڠȫƌWIṩҎЧɈеGMPQ^23İlչ҂60λSGMPңȫӋĿ^5000Ӌ1000͑ṩIգIձ鲼20ңKc\֪ˎLڵĺPϵ
҂Č҈FꠓSИI֪NMPAFDAEUWHOICHPIC/SMHRASWISSMEDICTGAGMPҎҪܠͬҺ͵^Ŀ͑ṩƻĽQհȫGMPԡSҎԡCSӋCϵyS|ͶMAH/MAAա
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