Sichuan Deebio Pharmaceutical Co., Ltd. (nke a na-akpọ Deebio) mere nyocha nnabata GMP gọọmentị sitere na PMDA na Japan site na Ọgọst 25 ruo Ọgọst 26th, 2022. Ndị otu nyocha GMP nwere ndị nyocha abụọ nke ndị ọkachamara nwere ahụmahụ duziri wee duzie usoro nyocha. nyocha ime anya ụbọchị abụọ.Ndị ọkachamara otu nyocha ahụ mere nyocha nke ọma nke usoro njikwa ogo nke Deebio, usoro njikwa mmepụta, ọrụ saịtị, njikwa ụlọ nyocha, yana akụrụngwa nkwado na akụrụngwa metụtara ya, yana ndozi sistemu ọha.Site na nlebanya, ndị ọkachamara n'otu nleba anya n'otu n'otu kwenye na nke ọma sistemụ njikwa ogo GMP Deebio.Site na mbọ njikọ nke ndị ọrụ niile nke ụlọ ọrụ ahụ, Deebio gafere asambodo GMP gọọmentị Japan PMDA!

Banyere Japan PMDA

PMDA (ụlọ ọrụ ọgwụ na ngwaọrụ ahụike), nke a makwaara dị ka “Independent Administrative Legal Person Pharmaceutical and Medical Device Comprehensive Institution”, bụ ụlọ ọrụ Japan na-ahụ maka nyocha teknụzụ nke ọgwụ na ngwaọrụ ahụike.Ọ na-arụ ọrụ dị ka FDA na United States na NMPA na China, yabụ a na-akpọkarị ya "Nchịkwa Ọgwụ Ọgwụ Japan".

Ọrụ bụ isi bụ iji hụ na ịdịmma, nchekwa na ịdị irè nke ngwaahịa na ngwaọrụ ọgwụ.PMDA na-ahụ maka ma nyochaa faịlụ Master Drug Master (MF) etinyere na ime nyocha GMP na ndị na-emepụta ọgwụ na ụlọ na nke mba ofesi na Japan, ha abụọ jikọtara ọnụ.

Ọgwụ ga-ebu ụzọ gafere nyocha teknụzụ MF wee gafere nyocha GMP nke saịtị mmepụta tupu ịnweta nnabata PMDA.Ndị na-ahụ maka ụlọ ọrụ na-ekwenyekarị na iwu PMDA bụ nke siri ike na nke kachasị mma n'ụwa, na enweghị nlezianya ọ bụla na nkọwa ga-eduga na nkwụsị nke nyocha MF ma ọ bụ ọdịda nke nyocha GMP, na-emetụta oge ịzụ ahịa ọgwụ.

Japan, nke nọ n'etiti 10 kachasị elu n'ihe gbasara ọnụ ọgụgụ ndị mmadụ n'ụwa, bụ obodo nke atọ kasị ukwuu n'ahịa ahịa ọgwụ na otu n'ime ndị isi atọ nke ICH (ndị ọzọ abụọ bụ United States na European Union).Ọ bụkwa onye otu PIC/S ọgbakọ.