isi_ọkọlọtọ

Akụkọ

Ugbu a, e nwere ihe karịrị ngwaọrụ ahụike 10,000 n'ụwa niile. 1 Mba ga-ebute nchekwa ndị ọrịa ụzọ ma hụ na ha nwere ngwaọrụ ahụike dị elu, dị nchebe ma dị irè. 2,3 Ahịa ngwaọrụ ahụike Latin America na-aga n'ihu na-eto eto na mmụba dị ukwuu kwa afọ. Mba Latin America na Caribbean kwesịrị ibubata ihe karịrị 90% nke ngwaọrụ ahụike n'ihi na mmepụta na inye ngwaọrụ ahụike mpaghara na-erughị 10% nke mkpokọta ọchịchọ ha.
Argentina bụ mba nke abụọ kachasị ukwuu na Latin America mgbe Brazil gasịrị. N'inwe ọnụ ọgụgụ mmadụ dị ihe dị ka nde 49, ọ bụ mba nke anọ kachasị nwee ọnụ ọgụgụ mmadụ na mpaghara ahụ4, yana akụ na ụba nke atọ kachasị ukwuu mgbe Brazil na Mexico gasịrị, yana ngwaahịa mba (GNP) nke ihe dị ka ijeri US$450. Ego kwa afọ nke Argentina na-enweta kwa onye bụ US$22,140, ​​​​otu n'ime ndị kachasị elu na Latin America. 5
Isiokwu a na-achọ ịkọwa ikike nke usoro nlekọta ahụike Argentina na netwọk ụlọ ọgwụ ya. Na mgbakwunye, ọ na-enyocha nhazi, ọrụ, na njirimara iwu nke usoro iwu ngwaọrụ ahụike Argentina na mmekọrịta ya na Mercado Común del Sur (Mercosur). N'ikpeazụ, na-atụle ọnọdụ akụ na ụba na mmekọrịta ọha na eze na Argentina, ọ na-achịkọta ohere azụmaahịa na ihe ịma aka ndị ahịa akụrụngwa Argentina na-anọchite anya ugbu a.
E kewara usoro nlekọta ahụike nke Argentina ụzọ atọ: nke ọha, nke ọha na eze na nke onwe. Ngalaba ọha na eze gụnyere ministri mba na nke mpaghara, yana netwọk nke ụlọ ọgwụ ọha na eze na ebe ahụike, na-enye ọrụ ahụike n'efu nye onye ọ bụla chọrọ nlekọta ahụike n'efu, nke bụ isi bụ ndị na-erughị eru maka nchekwa ọha na eze ma na-enweghị ike ịkwụ ụgwọ. Ego ego na-enye ego maka sistemụ nlekọta ahụike ọha na eze, ma na-enweta ụgwọ mgbe niile site na sistemụ nchekwa ọha iji nye ọrụ nye ndị mmekọ ya.
Usoro nchekwa ọha bụ iwu, nke lekwasịrị anya na "obra sociales" (atụmatụ ahụike otu, OS), na-ahụ na inye ọrụ nlekọta ahụike nye ndị ọrụ na ezinụlọ ha. Onyinye sitere n'aka ndị ọrụ na ndị were ha n'ọrụ na-akwado ọtụtụ sistemụ arụmọrụ, ha na-arụkwa ọrụ site na nkwekọrịta na ndị na-ere ahịa nkeonwe.
Usoro nkeonwe gụnyere ndị ọkachamara ahụike na ụlọ ọrụ nlekọta ahụike na-agwọ ndị ọrịa nwere nnukwu ego, ndị na-erite uru na OS, na ndị nwere mkpuchi nkeonwe. Usoro nkewa a gụnyekwara ụlọ ọrụ mkpuchi afọ ofufo a na-akpọ ụlọ ọrụ mkpuchi "ọgwụ akwụgoro ụgwọ tupu oge eruo". Site na ego mkpuchi, ndị mmadụ n'otu n'otu, ezinụlọ na ndị were n'ọrụ na-enye ego maka ụlọ ọrụ mkpuchi ahụike akwụgoro ụgwọ tupu oge eruo. Ụlọ ọgwụ ọha na eze 7 nke Argentina na-enweta 51% nke ọnụọgụgụ ụlọ ọgwụ ya niile (ihe dị ka 2,300), na-anọ n'ọkwa nke ise n'etiti mba Latin America nwere ọtụtụ ụlọ ọgwụ ọha na eze. Oke nke akwa ụlọ ọgwụ bụ akwa 5.0 maka 1,000 bi, nke dị elu karịa nkezi nke 4.7 na mba Organisation for Economic Co-operation and Development (OECD). Na mgbakwunye, Argentina nwere otu n'ime oke kachasị elu nke ndị dọkịta n'ụwa, yana 4.2 kwa 1,000 bi, gafere OECD 3.5 na nkezi nke Germany (4.0), Spain na United Kingdom (3.0) na mba Europe ndị ọzọ. 8
Òtù Ahụike Pan America (PAHO) edepụtala Nchịkwa Nkà na Ụzụ Nri, Ọgwụ na Ahụike nke Argentina (ANMAT) dị ka ụlọ ọrụ nchịkwa ọkwa anọ, nke pụtara na ọ nwere ike ịdị ka nke US FDA. ANMAT na-ahụ maka ilekọta na ijide n'aka na irè, nchekwa na ịdị mma dị elu nke ọgwụ, nri na ngwaọrụ ahụike. ANMAT na-eji usoro nhazi dabere na ihe egwu yiri nke ejiri na European Union na Canada na-ahụ maka ikike, ndebanye aha, nlekọta, nlekota na akụkụ ego nke ngwaọrụ ahụike n'ofe mba ahụ. ANMAT na-eji nhazi dabere na ihe egwu, nke a na-ekewa ngwaọrụ ahụike n'ime ụdị anọ dabere na ihe egwu nwere ike ime: Klas I - ihe egwu kacha ala; Klas II - ihe egwu ọkara; Klas III - ihe egwu dị elu; na Klas IV - ihe egwu dị oke elu. Onye nrụpụta mba ọzọ ọ bụla chọrọ ire ngwaọrụ ahụike na Argentina ga-ahọpụta onye nnọchi anya mpaghara iji nyefee akwụkwọ achọrọ maka usoro ndebanye aha. Mkpọpu infusion, mgbapụta sirinji na ọkpọkọ nri (mkpọpu nri) dị ka ngwa ahụike calss IIb, ga-ebufe na MDR ọhụrụ ka ọ na-erule 2024.
Dịka iwu ndebanye aha ngwaọrụ ahụike si dị, ndị nrụpụta ga-enwerịrị ụlọ ọrụ ma ọ bụ onye nkesa mpaghara debanyere aha na Ministry of Health nke Argentina iji rube isi na Best Manufacturing Practices (BPM). Maka ngwaọrụ ahụike Klas nke Atọ na Klas nke Atọ, ndị nrụpụta ga-enyerịrị nsonaazụ nnwale ahụike iji gosi nchekwa na ịdị irè nke ngwaọrụ ahụ. ANMAT nwere ụbọchị ọrụ 110 iji nyochaa akwụkwọ ahụ ma nye ikike kwekọrọ; maka ngwaọrụ ahụike Klas nke Atọ na Klas nke Atọ, ANMAT nwere ụbọchị ọrụ 15 iji nyochaa ma kwado. Ndebanye aha nke ngwaọrụ ahụike dị irè ruo afọ ise, onye nrụpụta nwekwara ike imelite ya ụbọchị 30 tupu ọ gwụchaa. E nwere usoro ndebanye aha dị mfe maka mgbanwe na asambodo ndebanye aha ANMAT nke ngwaahịa nke otu III na IV, a na-enyekwa nzaghachi n'ime ụbọchị ọrụ 15 site na nkwupụta nke nrubeisi. Onye nrụpụta ga-enyekwa akụkọ zuru oke nke ire ere ngwaọrụ ahụ na mba ndị ọzọ. 10
Ebe ọ bụ na Argentina bụ akụkụ nke Mercado Común del Sur (Mercosur) - mpaghara azụmaahịa nke mejupụtara Argentina, Brazil, Paraguay na Uruguay - a na-ana ụtụ isi na ngwaọrụ ahụike niile ebubatara dịka iwu Mercosur Common External Tariff (CET) si dị. Ọnụego ụtụ isi sitere na 0% ruo 16%. N'ihe gbasara ngwaọrụ ahụike emegharịrị emezigharịrị, ọnụego ụtụ isi sitere na 0% ruo 24%. 10
Ọrịa COVID-19 emetụtala Argentina nke ukwuu. 12, 13, 14, 15, 16 Na 2020, ngwaahịa mba ahụ dara site na 9.9%, nke bụ mbelata kachasị ukwuu n'ime afọ 10. N'agbanyeghị nke a, akụnụba obodo na 2021 ka ga-egosi nnukwu enweghị nguzozi akụ na ụba: n'agbanyeghị njikwa ọnụahịa gọọmentị, ọnụego mmụba kwa afọ na 2020 ka ga-adị elu ruo 36%. 6 N'agbanyeghị oke mmụba na mbelata akụ na ụba, ụlọ ọgwụ Argentina amụbaala ịzụrụ akụrụngwa ahụike dị mkpa na nke pụrụ iche na 2020. Mmụba na ịzụta akụrụngwa ahụike pụrụ iche na 2020 site na 2019 bụ: 17
N'otu oge ahụ site na 2019 ruo 2020, ịzụta akụrụngwa ahụike dị mkpa na ụlọ ọgwụ Argentina amụbaala: 17
Ọ dị mma ịmara na ma e jiri ya tụnyere 2019, a ga-enwe mmụba n'ọtụtụ ụdị ngwa ahụike dị oke ọnụ na Argentina na 2020, ọkachasị n'afọ ahụ mgbe a kagburu ma ọ bụ kwụsịtụ usoro ịwa ahụ nke chọrọ ngwa ndị a n'ihi COVID-19. Amụma maka 2023 na-egosi na ọnụego uto kwa afọ nke ngwa ahụike ọkachamara ndị a ga-abawanye:17
Argentina bụ mba nwere usoro ahụike dị iche iche, yana ndị na-enye ọrụ nlekọta ahụike ọha na nke onwe nke gọọmentị na-achịkwa. Ahịa ngwaọrụ ahụike ya na-enye ohere azụmaahịa dị mma n'ihi na Argentina kwesịrị ibubata ihe fọrọ nke nta ka ọ bụrụ ngwaahịa ahụike niile. N'agbanyeghị njikwa ego siri ike, mmụba ọnụ ahịa na obere itinye ego mba ofesi, 18 dị elu ugbu a maka akụrụngwa ahụike dị mkpa na nke pụrụ iche ebubata, usoro oge nkwenye iwu ezi uche dị na ya, ọzụzụ agụmakwụkwọ dị elu nke ndị ọkachamara ahụike Argentina, na ikike ụlọ ọgwụ dị mma nke mba ahụ Nke a na-eme ka Argentina bụrụ ebe mara mma maka ndị na-emepụta ngwaọrụ ahụike ndị chọrọ ịgbasa akara ukwu ha na Latin America.
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Julio G. Martinez-Clark bụ onye hiwere ma bụrụkwa onyeisi ụlọ ọrụ bioaccess, ụlọ ọrụ ndụmọdụ maka ohere ahịa nke na-arụkọ ọrụ na ụlọ ọrụ ngwaọrụ ahụike iji nyere ha aka ịme nnwale ahụike ngwa ngwa ma kwalite ihe ọhụrụ ha na Latin America. Julio bụkwa onye na-akwado LATAM Medtech Leaders podcast: mkparịta ụka kwa izu na ndị isi Medtech na-aga nke ọma na Latin America. Ọ bụ onye otu ndị ndụmọdụ nke mmemme ihe ọhụrụ na-akpata nsogbu nke Mahadum Stetson. Ọ nwere akara ugo mmụta bachelor na injinia eletrọniki na nzere masta na nchịkwa azụmaahịa.


Oge ozi: Sep-06-2021