I-Sichuan Deebio Pharmaceutical Co., Ltd. (ngemuva kwalokhu ebizwa ngokuthi i-Deebio) yenze ukuhlolwa okusemthethweni kokuhambisana kwe-GMP okuvela ku-PMDA e-Japan kusukela zingama-25 ku-Agasti kuya ku-Agasti 26, 2022. Ithimba labacwaningi mabhuku be-GMP lakhiwe abacwaningi mabhuku ababili abaholwa ochwepheshe abanolwazi ukuhlolwa okukude kwezinsuku ezimbili.Ochwepheshe bethimba lokuhlola benze ukuhlola okuphelele kohlelo lokuphatha ikhwalithi luka-Deebio, uhlelo lokuphatha ukukhiqizwa, ukusebenza endaweni, ukuphathwa kwelabhorethri, kanye nezinsiza ezihambisanayo ezisekelayo kanye nemishini, kanye nokugcinwa kwezinhlelo zomphakathi.Ngokuhlola, amalungu ochwepheshe bethimba lokuhlola aqinisekisa ngazwi linye futhi aqaphela kakhulu uhlelo lokuphatha ikhwalithi ye-Deebio ye-GMP.Ngemizamo ehlanganyelwe yabo bonke abasebenzi benkampani, u-Deebio uphumelele ngempumelelo isitifiketi se-GMP se-PMDA yaseJapan!

Mayelana ne-Japan PMDA

I-PMDA (I-Ejensi Yemithi Nezamadivayisi Ezokwelapha), eyaziwa nangokuthi “Isikhungo Esizimele Sokuphatha Sezomthetho Somuntu Wemithi Nedivayisi Yezokwelapha”, isikhungo sase-Japan esibhekele ukuhlolwa kobuchwepheshe kwezidakamizwa namadivayisi ezokwelapha.Isebenza ngokufana ne-FDA e-United States kanye ne-NMPA e-China, ngakho-ke yaziwa nangokuthi "i-Japan Drug Administration".

Isibopho esikhulu ukuqinisekisa ikhwalithi, ukuphepha, nokusebenza ngempumelelo kwemikhiqizo yezemithi kanye nemishini yezokwelapha.I-PMDA inesibopho sakho kokubili ukubuyekeza i-Drug Master File (MF) ethunyelwe kanye nokwenza ukuhlolwa kwe-GMP kubakhiqizi bezidakamizwa basekhaya nabangaphandle e-Japan, kokubili okuxhumene ngokwemvelo.

Umuthi kufanele uqale uphumelele ukubuyekezwa kobuchwepheshe be-MF futhi uphumelele ukuhlolwa kwe-GMP kwendawo yokukhiqiza ngaphambi kokuthola imvume ye-PMDA.Abangaphakathi embonini ngokuvamile bakholelwa ukuthi ukulawulwa kwe-PMDA kuqinile futhi kucophelela kakhulu emhlabeni, futhi noma yikuphi ukunganaki ngemininingwane kuzoholela ekumisweni kokubuyekezwa kwe-MF noma ukwehluleka kokuhlolwa kwe-GMP, okuthinta isikhathi sokuthengisa izidakamizwa.

I-Japan, ekleliswe kwabayishumi abahamba phambili ngokuminyana kwabantu emhlabeni, iyizwe lesithathu ngobukhulu emakethe yezidakamizwa futhi ingelinye lamalungu amathathu abalulekile e-ICH (amanye amalungu amabili yi-United States kanye ne-European Union).Futhi iyilungu lenhlangano ye-PIC/S.