amakuru

Laboratoire ya mbere itari ivuriro ya PMTA mu Bushinwa yararangiye, kandi uruganda rukuru ruteganya gufata uburenganzira bwa sisitemu y’umutekano ku isi;

Vuba aha, umunyamakuru yari azi ko ikigo cya Smoore Anlysis cyo gupima no gusuzuma umutekano (cyiswe “ikigo gishinzwe gusuzuma umutekano”) cyubatse laboratoire ya mbere y’Ubushinwa PMTA itari ivuriro.Kugeza ubu, laboratoire yakoze ubushakashatsi butari ivuriro rya PMTA, umutekano w’ibintu, HPHCs, ibizamini by’uburozi n’ibindi bintu bitari ivuriro.

Ni ubwambere Umushinwaitabi rya elegitoronikiuruganda rwubatse laboratoire ya PMTA.Irashobora kuyobora ibicuruzwa bya FEELM mbere yikizamini, kunoza byimazeyo umutekano wibicuruzwa, gufasha ikirango gutsinda neza PMTA. 

Nubwo ikigo cy’ibicuruzwa ku isi ku bicuruzwa by’itabi mu Bushinwa, ariko United Sates ni isoko rinini ry’abaguzi.Amerika yari ifite ibice birenga 55% by'isoko mpuzamahanga ku isi yose mu 2021 kandi izarenga 65% muri 2022 (Igitabo cy’ubururu cyoherezwa mu mahanga 2022 E-Itabi).Ibicuruzwa byanditswemo n’inganda zo mu Bushinwa ODM / OEM bigomba gutsinda igenzura rikomeye ry’umutekano ku isi mbere yo kwinjira ku isoko ry’Amerika. Kwipimisha umutekano no kwerekana buri gihe ibicuruzwa byahoze ari intege nke z’abatanga ikoranabuhanga mu Bushinwa. 

Ariko, kuva hashyirwaho laboratoire yambere yubushakashatsi muri 2017, Smoore yakomeje gutegura imishinga yambere yo kwipimisha kwisi no kubaka sisitemu yerekana umutekano wibicuruzwa.Kugeza ubu, Smoore Safety Assessment Centre yashyizeho laboratoire ya mbere ya E&L isesengura no gupima laboratoire, itezimbere urwego rw’umutekano w’ibikoresho by’umwuka kugeza ku rwego rw’ubuvuzi. 

Muri Mata uyu mwaka, umukiriya wa FEELM NJOY yemerewe na PMTA kugurishwa ku isoko ry’Amerika. FDA yatekereje ko ibicuruzwa bya NJOY bifite urugero rwa HPHCs ugereranije n’itabi, kandi ko abakoresha ibicuruzwa bya NJOY bahura n’urwego rwo hasi rw’ibintu bishobora kwangiza kandi bifite ibyiza kugabanya ingaruka kuruta itabi.Ibicuruzwa bya vape bicuruzwa byakozwe na Smoore, nabyo byatsinze PMTA.

Kugeza ubu, hari ibicuruzwa umunani byemejwe na FDA, ibyinshi muri byo bikoreshwa na Smoore.Sisitemu yo gucunga neza uruganda igira uruhare runini mugusuzuma FDA, kandi kuba ibicuruzwa bya OEM bya SEMore bishobora gutsinda PMTA byerekana ko FDA yamenye byibuze ko uruganda rwa OEM rwujuje ibyangombwa bisabwa mu micungire y’ubuziranengeuruganda rw'itabiibimera.