I-Sichuan Deebio Pharmaceutical Co., Ltd. (emva koku ibizwa ngokuba yi-Deebio) iye yahlolwa ngokusemthethweni ukuthobela i-GMP ukusuka kwi-PMDA eJapan ukusuka ngomhla wama-25 kuAgasti ukuya kumhla wama-26 ku-Agasti ka-2022. uphicotho olukude lweentsuku ezimbini.Iingcali zeqela lokuhlola zenze uhlolo olucokisekileyo lwenkqubo yolawulo lomgangatho kaDeebio, inkqubo yolawulo lwemveliso, ukusebenza kwindawo, ulawulo lwebhubhoratri, kwakunye nezixhobo ezixhasayo ezinxulumeneyo kunye nezixhobo, kunye nokugcinwa kweenkqubo zoluntu.Ngokuhlola, amalungu eengcaphephe eqela lokuhlola angqine ngamxhelomnye kwaye ayamkeleka kakhulu inkqubo yolawulo lomgangatho we-GMP kaDeebio.Ngemizamo edibeneyo yabo bonke abasebenzi benkampani, u-Deebio uphumelele ngempumelelo isatifikethi se-GMP saseJapan PMDA!

Malunga neJapan PMDA

I-PMDA (i-Arhente ye-Pharmaceuticals kunye ne-Medical Devices Agency), eyaziwa ngokuba yi "I-Independent Administrative Legal Person Pharmaceutical and Medical Device Comprehensive Institution", yi-arhente yaseJapan ejongene novavanyo lobugcisa lwamachiza kunye nezixhobo zonyango.Isebenza ngokufana ne-FDA e-United States kunye ne-NMPA e-China, ngoko ke ikwabizwa ngokuba yi "Japan Drug Administration".

Olona xanduva kukuqinisekisa umgangatho, ukhuseleko, kunye nokusebenza kakuhle kweemveliso zamayeza kunye nezixhobo zonyango.I-PMDA inoxanduva lokuphonononga iFayile eyiNkosi yeDrug Master (MF) engenisiweyo kwaye iqhube uhlolo lwe-GMP kubenzi bamachiza basekhaya nabangaphandle eJapan, zombini ezi zidityanisiwe.

Ichiza kufuneka kuqala liphumelele uphononongo lobugcisa lwe-MF kwaye liphumelele ukuhlolwa kwe-GMP kwindawo yokuvelisa ngaphambi kokufumana imvume ye-PMDA.Abantu bangaphakathi kwishishini ngokubanzi bakholelwa ukuba ummiselo we-PMDA ngowona ungqongqo kwaye ucokisekileyo kwihlabathi, kwaye nakuphi na ukungakhathali kwiinkcukacha kuya kukhokelela ekumisweni kophononongo lwe-MF okanye ukusilela kohlolo lwe-GMP, okuchaphazela ixesha lokuthengisa amachiza.

IJapan, ephakathi kwabali-10 abaphezulu malunga noxinaniso lwabemi ehlabathini, lilizwe lesithathu ngobukhulu borhwebo lweziyobisi kunye nelinye lamalungu amathathu angundoqo e-ICH (amanye amalungu amabini yi-United States ne-European Union).Ikwalilungu lombutho wePIC/S.