Nibihe bisabwa byo kohereza masike mubihugu bitandukanye

Kohereza muri Amerika

Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA) giteganya ko ibikoresho by’ubuvuzi, ibiryo, inzoga, ibiyobyabwenge n’inganda zindi zitari muri Amerika bigomba kwandikwa kandi hagomba gushyirwaho umukozi w’Amerika mbere yuko bishyirwa ku rutonde muri Amerika.

Igice cya 80CIyo wiyandikishije mu ruganda, uwabikoze agomba kumenyesha amakuru y’umukozi w’Amerika muri FDA mu buryo bwa elegitoronike mu buryo bwo kwiyandikisha no gutondeka (Sisitemu ya FURLS), harimo izina, aderesi, telefoni, fax na imeri y’umukozi w’Amerika.

Ku bicuruzwa ibyo aribyo byose, ibigo bigomba kwiyandikisha no gutondeka ibicuruzwa.

Ku bicuruzwa byo mu cyiciro cya I (bingana na 47%), Igenzura rusange rirakoreshwa.Ibicuruzwa byinshi birashobora kwinjira ku isoko ry’Amerika gusa kwiyandikisha, gutondeka no gushyira mu bikorwa ibisobanuro bya GMP (bike muri byo bisonewe muri GMP, kandi bike mu bicuruzwa byabitswe bigomba gutanga ibyifuzo 510 (K) muri FDA, ni ukuvuga PMN (Kumenyesha Premarket ));

Kohereza mu Buyapani

Ibigo byubuvuzi bifuza gushyira ibicuruzwa byabo ku isoko ry’Ubuyapani bigomba kuba byujuje ibisabwa n’amategeko y’Ubuyapani y’imiti n’ubuvuzi (PMD Act).

Niba ibigo byubuvuzi bifuza gushyira ibicuruzwa byabo mumasoko yUbuyapani, bagomba kuba bujuje ibyangombwa byamategeko agenga imiti nubuvuzi (PMD Act) Yapani.

Ikigo gishinzwe imiti n’ubuvuzi (PMDA), ishami rishinzwe minisiteri y’ubuzima, umurimo n’imibereho myiza (MHLW), nacyo cyasohoye amabwiriza make mu cyongereza.Nyamara, ibibazo byindimi hamwe nuburyo bugoye bwo gutanga ibyemezo biracyari ingingo igoye yo kwandikisha ibikoresho byubuvuzi mubuyapani.

Nkuko bisabwa n’itegeko rya PMD, sisitemu yo kwiyandikisha ya TOROKU isaba abakora mu gihugu kwandikisha amakuru y’uruganda n’inzego zibishinzwe zibifitiye ububasha babiherewe uburenganzira na guverinoma, harimo igishushanyo mbonera, ibicuruzwa n’amakuru y’ibanze;Abakora mu mahanga bagomba kwandikisha amakuru yakozwe na PMDA.

Bisabwe n'Itegeko rya PMD, Sisitemu yo Kwiyandikisha ya Toroku isaba Abakora mu Gihugu kwandikisha amakuru y'uruganda hamwe n'abayobozi b'inzego z'ibanze babiherewe uburenganzira na Guverinoma, harimo Igishushanyo mbonera, Umusaruro n'amakuru y'ingenzi;Abahinguzi b’amahanga bagomba kwandikisha amakuru yinganda hamwe na PMDA.

Kohereza muri Koreya y'Epfo

Minisiteri y’ubuzima (MHW) muri Koreya yepfo, yitwa Minisiteri y’ubuzima muri make, ishinzwe cyane cyane gucunga ibiribwa, ibiyobyabwenge, amavuta yo kwisiga n’ibikoresho by’ubuvuzi, kandi n’urwego runini rw’ubuzima.Dukurikije amategeko y’ibikoresho by’ubuvuzi, Minisiteri y’ibiribwa n’umutekano w’ibiyobyabwenge (MFDS) muri minisiteri y’ubuzima n’imibereho myiza ya Koreya yepfo ishinzwe kugenzura ibikoresho by’ubuvuzi.

Amategeko y’ibikoresho by’ubuvuzi muri Koreya ashyira ibikoresho byubuvuzi mu byiciro bine (I, II, III, IV), bisa cyane n’ubumwe bw’ibihugu by’i Burayi gushyira mu byiciro by’ubuvuzi.

Amategeko y’ibikoresho by’ubuvuzi bya koreya agabanya ibikoresho byubuvuzi mu byiciro bine (I, II, III na IV), Bisa cyane cyane n’ubumwe bw’ibihugu by’i Burayi gushyira mu byiciro by’ubuvuzi.

Icyiciro cya I: ibikoresho byubuvuzi bifite akaga gashobora kubaho;

Icyiciro cya II: ibikoresho byubuvuzi bifite ibyago bike;

Icyiciro cya III: ibikoresho byubuvuzi bifite akaga gashobora kuba;

Icyiciro cya IV: Ibikoresho byubuvuzi bishobora guteza akaga.

Ibyiciro byibikoresho byubuvuzi: urwego rwibyago, aho uhurira nigihe cyumubiri wumuntu, umutekano nibikorwa byibicuruzwa.

Ibikoresho byo mu cyiciro cya I n'icya II bizemezwa na "Ikigo cy’ubuvuzi gishinzwe amakuru y’ikoranabuhanga (MDITAC)", kandi ibikoresho bimwe byo mu cyiciro cya II (ibikoresho bishya), ibikoresho byo mu cyiciro cya III n’icyiciro cya IV bizemezwa n’ubuyobozi bushinzwe umutekano w’ibiribwa n’ibiyobyabwenge muri Koreya.

Ibikoresho byose byubuvuzi byoherejwe muri Ositaraliya bigomba gusaba kwiyandikisha muri TGA.TGA ni impfunyapfunyo yubuyobozi bwibicuruzwa bivura.Izina ryayo ryuzuye nubuvuzi bwibicuruzwa.Nicyo kigo gishinzwe kugenzura ibicuruzwa bivura (harimo ibiyobyabwenge, ibikoresho byubuvuzi, ikoranabuhanga rya geneti n’ibicuruzwa byamaraso) muri Ositaraliya.

Ibisobanuro by'ibikoresho by'ubuvuzi muri Ositaraliya byegereye CE ya EU, kandi ibyiciro birahuza.Bitandukanye na FDA yo muri Amerika, ubwoko bwinyamaswa ntabwo bugengwa na TGA.Bisa na FDA, ugomba kwerekana ibisekuru