Ngo-1965, i-European Community yaqulunqa iMedicines Directive (65/EEC) ukuze idibanise imithetho nemimiselo enxulumene namayeza ezityalo phakathi kwamazwe.Ngowe-1988, iEuropean Community yaqulunqa iGuidelines for the Management of Herbal Products, eyathi ngokucacileyo: “Amayeza esintu luhlobo oluthile lweyeza, yaye izinto ezisebenzayo eziqulethwe kuwo zizityalo kuphela okanye amayeza esintu.Amayeza esintu kufuneka abe nelayisensi yokuthengisa.Imigangatho yomgangatho, yokhuseleko kunye nokusebenza kakuhle kufuneka kuhlangatyezwane nayo phambi kokuba imveliso ithengiswe.”Isicelo selayisenisi siyafuneka ukuba sinikezele ngolu lwazi lulandelayo: 1. Ulwazi lomgangatho kunye nobungakanani bamacandelo;2. Inkcazo yendlela yokuvelisa;3. Ukulawulwa kwezinto zokuqala;4. Ulawulo lomgangatho kunye nokuchongwa kufuneka kuqhutywe rhoqo;5. Ukulawulwa komgangatho kunye novavanyo lweemveliso ezigqityiweyo;6. Ukuchongwa kozinzo.Ngo-1990, uMbutho waseYurophu wenze isiphakamiso se-GMP malunga nokuveliswa kwamayeza esintu.
NgoDisemba 2005, iyeza lemveli iKlosterfrauMelisana yabhaliswa ngempumelelo eJamani.Le mveliso ikakhulu iqulathe ingca yebhalsam, ivumba elimnandi, i-angelica, ijinja, i-clove, i-galangal, i-Eurogentian, ukunyanga uxinzelelo lwengqondo kunye nokuxhalaba, intloko ebuhlungu, i-dysmenorrhea, ukuphelelwa ngumdla, i-dyspepsia, iingqele njalo njalo.E-UK, kukho amakhulu ezicelo zokubhaliswa kwamayeza esintu, kodwa ukuza kuthi ga ngoku akukho nalinye kumayeza emveli aseTshayina.
Ingcamango esisiseko yamachiza e-United States kukuba ukubunjwa kweekhemikhali kufuneka kucace, kwaye kwimeko yamalungiselelo e-compound, i-pharmacodynamics yecandelo ngalinye lemichiza kunye nemiphumo yokusebenzisana kwabo ekusebenzeni kunye nobuthi kufuneka kucace.Phantsi kweempembelelo zento ebizwa ngokuba yi-orthodox concept yeyeza, i-US FDA inokuqonda okulambathayo kakhulu kumayeza ezityalo, kubandakanywa namayeza emveli aseTshayina, ngoko ke ayilamkeli iyeza lendalo lezityalo njengeyeza.Nangona kunjalo, phantsi koxinzelelo lwenkcitho enkulu yokhathalelo lwezonyango kunye noluvo oluluqilima loluntu, iNkongolo yase-US yapasisa i-Dietarysupplement Health Education Act (DSHEA) ngo-1994 ngeenzame ezingagungqiyo kunye nokuphembelela amashishini amancinci naphakathi, adwelise amayeza endalo ezityalo kubandakanya. iyeza lemveli laseTshayina njengezongezo zokutya.Kunokuthiwa ukuba isongezelelo sokutya yimveliso ekhethekileyo phakathi kokutya kunye neyeza.Nangona isalathisi esithile singabonakaliswa, umsebenzi walo wokunakekelwa kwempilo unokuboniswa.
Amayeza endalo esintu aveliswa aze athengiswa eUnited States anesimo esisemthethweni, oko kukuthi, amkelwa ukuba asetyenziswe ekuthinteleni nasekunyangeni izifo.Kwi-2000, ekuphenduleni imfuno yoluntu, uMongameli wase-United States wagqiba ekubeni aseke "****** iBhunga loMgaqo-nkqubo kwi-Complementary and Alternative Medicine", kunye namalungu angama-20 atyunjwe nguMongameli ngokuthe ngqo ukuba axoxe ngezikhokelo zomgaqo-nkqubo wokuncedisa. kunye nelinye iyeza kunye nokuphonononga ixabiso elinokubakho.Kwingxelo yayo esemthethweni kuMongameli kunye neCongress ngo-2002, ****** iquka "amayeza esintu aseTshayina" kwinkqubo yonyango oluncedisayo kunye nolunye.
Kwiminyaka yakutshanje, i-FDA yomeleza ulawulo lolawulo lwamayeza endalo esintu.Ngo-2003, yaqala ukuphumeza ulawulo lwe-GMP kwizongezo zokutya kunye nokumisela imigangatho engqongqo yokuvelisa kunye nokuleyibhelishwa kwezongezo zokutya.I-FDA yapapasha iziKhokelo zoPhuhliso lweZiyobisi zeZityalo kwi-intanethi kwaye yacela izimvo kwihlabathi jikelele.ImiGaqo yesiKhokelo ichaza ngokucacileyo ukuba amayeza ebhotani ahlukile kumayeza ekhemikhali, ngoko ke iimfuno zawo zobuchwephesha kufuneka zahluke kulawo amva, kwaye zicacisa ezinye iimpawu zamayeza ebhotani: ukwakheka kweekhemikhali zamayeza ebhotani kudla ngokuba ngumxube wamacandelo amaninzi, endaweni yoko. kunekhompawundi enye;Ayizizo zonke iikhemikhali ezikumayeza esintu ****** acacileyo;Kwiimeko ezininzi, izithako ezisebenzayo zamayeza esintu azimiselwanga ******;Kwezinye iimeko, umsebenzi webhayoloji weyeza zityalo awukho ****** uqinisekileyo kwaye ucacile;Iindlela ezininzi zokulungiselela nokusetyenzwa kwamayeza esintu ubukhulu becala zinobungqina;I-Botanicals inamava amaninzi kunye nexesha elide ekusebenzeni komntu.Akukho ziphumo ebezingalindelekanga ezinetyhefu eziye zafunyanwa kwixesha elide kunye nesicelo esibanzi samayeza esintu emzimbeni womntu.Amanye amayeza esintu athengiswe njengeemveliso zempilo okanye izongezo zesondlo.
Ngokusekwe ekuqondeni kwe-FDA ngamachiza ezityalo, iimfuno zobugcisa zamachiza ezityalo kwiMigaqo eKhokelayo zihluke kwezo zamachiza ekhemikhali, kubandakanywa: iimfuno zobugcisa zophando lwangaphambili zikhululekile;Uvavanyo lwe-pharmacokinetic lunokuphathwa ngokuguquguqukayo.Unyango olukhethekileyo lwamalungiselelo e-herbal compound;Itekhnoloji yamayeza ifuna ukusetyenzwa okuguquguqukayo;Iimfuno zobugcisa ze-pharmacology kunye ne-toxicology ziye zancitshiswa.Izikhokelo zibonisa umtsi osemgangathweni kwindlela ye-FDA kumayeza endalo esintu, kuqukwa namayeza emveli aseTshayina.Utshintsho olukhulu lomgaqo-nkqubo karhulumente waseMelika malunga neyeza leyeza lidale iimeko ezisisiseko ukuze amayeza esintu angene kwimarike yaseMelika.
Ukongeza kwiVeregen, esele ivunyiwe, malunga ne-60 ukuya kwi-70 botanicals isendleleni ukuza kuthi ga ngoku.
Ixesha lokuposa: Dec-09-2022
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