China bans GSK from drug procurement activities through April 2024 – Endpoints News

Fol­low­ing an in­spec­tion of GSK’s CD­MO Poz­nan, Poland-based site that iden­ti­fied ques­tion­able prac­tices, Chi­na has de­cid­ed to ban the com­pa­ny from par­tic­i­pat­ing in its cen­tral­ized drug pro­cure­ment pro­gram through April 29, 2024, ac­cord­ing to an Eng­lish trans­la­tion of a re­cent gov­ern­ment post­ing.
The plant in ques­tion is a GSK con­tract man­u­fac­trur­er’s, which sup­plies the uri­nary re­ten­tion drug du­tas­teride, and Chi­na’s State Food and Drug Ad­min­is­tra­tion found the com­pa­ny did not con­duct batch-by-batch and full-item in­spec­tions of the prod­ucts ex­port­ed to Chi­na, as well as iden­ti­fied de­fi­cien­cies in the pre­ven­tion and con­trol of mi­cro­bial con­t­a­m­i­na­tion risks.
GSK sold the man­u­fac­tur­ing site to French CD­MO Del­pharm in Oct. 2020 as the British drug­mak­er sold oth­er as­sets too. Com­ment­ing on the lat­est dis­rup­tion, GSK said in a state­ment:
GSK’s vol­ume-based pro­cure­ment agree­ment with Chi­na for the sup­ply of Avo­dart (du­tas­teride) ex­pired on 30 Oc­to­ber. Due to a re­view of man­u­fac­tur­ing process­es fol­low­ing an in­spec­tion of our con­tract man­u­fac­tur­er, sup­ply of Avo­dart to Chi­na is cur­rent­ly on hold. For this rea­son, GSK will not be el­i­gi­ble to take part in the next vol­ume-based pro­cure­ment agree­ment for this prod­uct. This ex­clu­sion on­ly ap­plies to Avo­dart – no oth­er GSK prod­ucts are sup­plied to Chi­na through a vol­ume-based pro­cure­ment pro­gramme.
Chi­na’s SF­DA said it sus­pend­ed the im­port, sale and use of GSK du­tas­teride soft cap­sules, and all drug im­port ports in Chi­na have sus­pend­ed the is­suance of im­port cus­toms clear­ance forms.
GSK ac­quired the Pol­ish site in 1998 and, ac­cord­ing to a 2018 re­port, spent around $500 mil­lion there over 20 years, with the pro­duc­tion of 8.7 mil­lion tablets and 1.3 mil­lion cap­sules every day for 130 coun­tries.
In March 2019, the drug­mak­er an­nounced plans for a fi­nan­cial hub in Poz­nań, which will stay in GSK’s hands mov­ing for­ward, the com­pa­ny said in a re­lease. The hub em­ploys be­tween 200 and 300 em­ploy­ees, GSK said pre­vi­ous­ly.
“The com­pre­hen­sive as­sess­ment of the pro­duc­tion qual­i­ty man­age­ment of this va­ri­ety does not meet the re­quire­ments of Chi­na’s ‘Good Man­u­fac­tur­ing Prac­tice for Drugs’ (re­vised in 2010). On Oc­to­ber 31, 2022, the State Drug Ad­min­is­tra­tion is­sued an an­nounce­ment to sus­pend the im­port, sale and use of this prod­uct from now on,” Chi­na’s SM­PA wrote on its web­site.
The de­ci­sion to ban GSK came af­ter the col­lec­tive de­lib­er­a­tion of the rel­e­vant mem­bers of the state-or­ga­nized Drug Joint Pro­cure­ment Of­fice, with the SM­PA writ­ing that the com­pa­ny’s qual­i­fi­ca­tion to par­tic­i­pate in the cen­tral­ized drug pro­cure­ment ac­tiv­i­ties or­ga­nized by the state from to­day to April 29, 2024, will be sus­pend­ed.
“In view of the fact that the pro­cure­ment cy­cle of du­tas­teride ends at the end of Oc­to­ber, and the re­place­ment pro­ce­dure will no longer be ini­ti­at­ed, all lo­cal­i­ties are re­quest­ed to pay at­ten­tion to the sup­ply of this drug in the fol­low-up work af­ter the pro­cure­ment cy­cle ex­pires, and do a good job in con­nec­tion work to en­sure a sta­ble drug sup­ply,” the gov­ern­ment added, ac­cord­ing to an Eng­lish trans­la­tion.
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