I te 23 o Hune, i tukuna e te FDA tētahi pānui ko "te rēhitatanga me te rārangi taputapu" te taitara i runga i tana paetukutuku mana, e whakanui ana i:
Kāore te FDA e tuku Tiwhikete Rēhita ki ngā whare taputapu hauora. Kāore te FDA e whakamana i te rēhitatanga me te rārangi.
ngā mōhiohio mō ngā umanga kua rēhita me te rārangi. Kāore te Rēhitatanga me te Rārangi e tohu ana i te whakaae, i te whakaaetanga rānei o tētahi umanga
ā rātou taputapu rānei.
Ko ngā take me aro atu tātou ki te rēhitatanga o te FDA ko ēnei e whai ake nei:
Pātai 1: ko tēhea tari i whakaputa i te tiwhikete FDA?
A: kāore he tiwhikete mō te rēhitatanga FDA. Mena kua rēhitatia te hua ki te FDA, ka riro mai te nama rēhitatanga. Ka hoatu e te FDA he reta whakautu ki te kaitono (kua hainatia e te tumuaki whakahaere o te FDA), engari kāore he tiwhikete FDA.
He whakamaumaharatanga kaha te panuitanga a te FDA mō tēnei momo pānui i tēnei wā! Nā te whanaketanga o te mate urutā i te United States, kua tino piki ake te hiahia mō ngā hua ārai mate urutā hauora e kaweake ana ki te United States, ā, kua piki ake hoki te hiahia mō te rēhitatanga kaweake.
Ina whakataruna ētahi umanga i a rātou anō hei FDA hei tuku tiwhikete ki ngā kaihanga, ka whiwhi pea ētahi umanga tohatoha i ngā "tiwhikete FDA" rūpahu ina kōrero ana ki ngā kaihanga.
Pātai 2: me whai taiwhanga whaimana te FDA?
A: He tari whakahaere ture te FDA, ehara i te tari ratonga. Ki te mea tetahi he taiwhanga tiwhikete FDA rātou, kei te tinihanga rātou i ngā kaihoko, nā te mea kāore he ratonga tūmatanui a te FDA.
Ngā tari me ngā taiwhanga tiwhikete ira tangata, kāore he mea e kiia nei he "taiwhanga kua tohua". Hei tari whakahaere ture ā-motu, kaua te FDA e uru ki ngā mahi pēnei i te noho hei kaiwhakawa me te kaitākaro. Ka whakamātautau noa te FDA i ngā ratonga
Ka whakamanahia te kounga GMP o te taiwhanga, ā, ka tukuna te tiwhikete ki te mea whai tohu, engari e kore e "tohua" e te marea, e taunakitia rānei.
Pātai 3: me whai kaihoko US te rēhitatanga FDA?
Āe, me whakatū e te umanga he tangata whenua o Amerika (kamupene/Rōpū) hei māngai mōna ina rēhita ki te FDA. Ko te māngai te kawenga mō ngā ratonga tukatuka kei roto i te Hononga o Amerika, koinei te pāpāho hei whakapā atu ki te FDA me te kaitono.
Ngā hapa noa i te rēhitatanga o te FDA
1. He rerekē te rēhitatanga FDA i te tiwhikete CE. He rerekē tōna aratau tiwhikete i te aratau tiwhikete whakamātautau hua tiwhikete CE me te ripoata. Ko te rēhitatanga FDA e whakamahi ana i te aratau whakapuakitanga pono, arā, he pono tō whakapuakitanga mō āu ake hua.
E ai ki ngā paerewa me ngā whakaritenga haumaru e tika ana, ā, kua rēhitatia ki te paetukutuku ā-Motu o Amerika, mēnā he aituā ki te hua, me waha e ia te kawenga e rite ana. Nō reira, i te rēhitatanga FDA mō te nuinga o ngā hua, kāore he whakamātautau tauira e tukuna ana.
Me te tauākī tiwhikete.
2. Te wā whai mana o te rēhitatanga FDA: Kotahi tau te mana o te rēhitatanga FDA. Mena he roa ake i te kotahi tau, me tuku anō kia rēhitatia, ā, me utu anō hoki te utu ā-tau.
3. Kua rēhitatia te FDA me tētahi tiwhikete?
Ina hoki, kāore he tiwhikete mō te rēhitatanga FDA. Mena kua rēhitatia te hua ki te FDA, ka riro mai te nama rēhitatanga. Ka hoatu e te FDA he reta whakautu ki te kaitono (kua hainatia e te tumuaki whakahaere o te FDA), engari kāore he tiwhikete FDA.
Ko te tiwhikete e kitea ana e tātou i te nuinga o te wā ka tukuna e te tari takawaenga (kaihoko rēhita) ki te kaihanga hei whakaatu kua āwhina i te kaihanga ki te whakaoti i te "rēhitatanga whare whakaputa me te rēhitatanga momo hua" e hiahiatia ana e te FDA.
(rēhitatanga o te whare me te rārangi taputapu), ko te tohu kua whakaotihia hei āwhina i te kaihanga ki te tiki i te nama rēhitatanga FDA.
E ai ki ngā taumata mōrearea rerekē, ka wehea e te FDA ngā taputapu hauora kia toru ngā wāhanga (I, II, III), ā, ko te akomanga III te mea kei a ia te taumata mōrearea teitei rawa.
Kua whakamāramahia e te FDA ngā whakaritenga whakarōpūtanga me te whakahaere o ngā hua mō ia taputapu hauora. I tēnei wā, neke atu i te 1700 ngā momo rārangi taputapu hauora. Ki te hiahia tētahi taputapu hauora ki te tomo ki te mākete o Amerika, me whakamārama tuatahi i ngā whakaritenga whakarōpūtanga me te whakahaere o ngā hua e whakamahia ana mō te hokohoko.
I muri i te whakamārama i ngā mōhiohio o runga ake nei, ka taea e te umanga te tīmata ki te whakarite i ngā rauemi tono e tika ana, me te tuku pūrongo ki te FDA i runga i ētahi tikanga hei whiwhi whakaaetanga. Mō tētahi hua, me rēhita ngā umanga me te whakarārangi i ngā hua.
Mō ngā hua akomanga I (tata ki te 47%), ka whakatinanahia te mana whakahaere whānui. Ko te nuinga o ngā hua me rēhita noa, me whakarārangi me whakatinana i ngā paerewa GMP, ā, ka taea e ngā hua te uru ki te mākete o Amerika (he iti noa iho o ēnei e hono ana ki te GMP).
He iti noa iho ngā hua kua rāhuitia me tuku tono 510 (k) ki te FDA, arā, PMN (pānui i mua i te mākete));
Mō ngā hua akomanga II (tata ki te 46%), ka whakatinanahia he mana whakahaere motuhake. Whai muri i te rēhitatanga me te rārangi, me whakatinana e ngā umanga te GMP me te tuku tono 510 (k) (he iti noa ngā hua ka whakakorehia i te 510 (k));
Mō ngā hua akomanga III (tata ki te 7%), ka whakatinanahia te raihana i mua i te hokohoko. Whai muri i te rēhitatanga me te rārangi, me whakatinana e ngā umanga te GMP me te tuku tono PMA (tono i mua i te hokohoko) ki te FDA (Wāhanga III).
PMN).
Mō ngā hua akomanga I, i muri i te tukunga a te hinonga i ngā mōhiohio e tika ana ki te FDA, ka panuitia noa e te FDA, ā, kāore he tiwhikete e tika ana e tukuna ana ki te hinonga; mō ngā taputapu akomanga II me te III, me tuku e te hinonga te PMN, te PMA rānei, ā, mā te FDA e mahi.
Hoatu he reta whakaae whaimana ki te umanga, arā, kia whakaaetia te umanga ki te hoko tika i ana hua ki te mākete taputapu hauora o Amerika i raro i tōna ake ingoa.
Ko te FDA te mea e whakatau ana mēnā me haere ki te umanga mō te aromatawai GMP i roto i te tukanga tono, e ai ki te taumata mōrearea o te hua, ngā whakaritenga whakahaere me ngā urupare mākete me ētahi atu āhuatanga whānui.
Mai i ngā kōrero o runga ake nei, ka kite tātou ka taea e te nuinga o ngā hua te whiwhi tiwhikete FDA i muri i te rēhitatanga, te whakarārangi hua me te whakatinanatanga o te GMP mō ngā taputapu hauora, te tuku tono 510 (k) rānei.
Me pēhea te tirotiro mēnā kua rārangihia te hua e te FDA, kua rēhitatia rānei ki te 510k?
Ko te huarahi whai mana anake: tirohia te paetukutuku a te FDA
Wā tuku: Hanuere-09-2021