Muyezo wa malamulo

Mu 1965, European Community inapanga Medicines Directive (65/EEC) kuti agwirizanitse malamulo ndi malamulo okhudzana ndi mankhwala omera pakati pa mayiko.Mu 1988, bungwe la European Community linapanga buku lakuti Guidelines for the Management of Herbal Products, limene linanena momveka bwino kuti: “Mankhwala azitsamba ndi mtundu wa mankhwala, ndipo zinthu zogwira ntchito zimene zili mmenemo ndi zomera kapena mankhwala a zitsamba.Mankhwala azitsamba ayenera kukhala ndi chilolezo chogulitsidwa.Miyezo yabwino, chitetezo ndi mphamvu ziyenera kutsatiridwa musanagulitsidwe. ”Kufunsira kwa laisensi kumafunika kuti mupereke zambiri izi: 1. Ubwino ndi kuchuluka kwa zigawo;2. Kufotokozera za njira yopangira;3. Kulamulira kwa zipangizo zoyamba;4. Kuwongolera kwaubwino ndi kuzindikiritsa kuti zizichitika pafupipafupi;5. Kuwongolera ndi kuwunika kwazinthu zomwe zamalizidwa;6. Kuzindikiritsa kukhazikika.Mu 1990, European Community inaganiza zopanga GMP kuti apange mankhwala azitsamba.
Mu December 2005, mankhwala achikhalidwe KlosterfrauMelisana adalembetsa bwino ku Germany.Mankhwalawa makamaka amakhala ndi udzu wa basamu, kununkhira kwachibadwidwe, angelica, ginger, clove, galangal, Eurogentian, kuchiza kupsinjika kwa malingaliro ndi nkhawa, kupweteka mutu, dysmenorrhea, kusowa kwa njala, dyspepsia, kuzizira ndi zina zotero.Ku UK, pali mazana ofunsira kulembetsa mankhwala azikhalidwe, koma pakadali pano palibe mankhwala achi China.

Mfundo yaikulu ya mankhwala ku United States ndi yakuti mankhwala ayenera kukhala omveka bwino, ndipo pankhani ya kukonzekera pawiri, pharmacodynamics ya chigawo chilichonse cha mankhwala ndi zotsatira za kuyanjana kwawo pa efficacy ndi kawopsedwe ayenera kukhala omveka.Mothandizidwa ndi zomwe zimatchedwa lingaliro lachidziwitso lamankhwala, US FDA ili ndi chidziwitso chochepa kwambiri cha mankhwala a zomera, kuphatikizapo mankhwala achi China, kotero sichizindikira mankhwala a zomera zachilengedwe monga mankhwala.Komabe, mokakamizidwa ndi ndalama zambiri zachipatala komanso maganizo a anthu, bungwe la US Congress linapereka lamulo la dietarysupplement Health Education Act (DSHEA) mu 1994 chifukwa cha khama komanso kukakamiza mabizinesi ang'onoang'ono ndi apakatikati, omwe adalemba mankhwala achilengedwe kuphatikizapo mankhwala achilengedwe. mankhwala achi China ngati chowonjezera pazakudya.Tinganene kuti zakudya zowonjezera ndi mankhwala apadera pakati pa chakudya ndi mankhwala.Ngakhale kuti chisonyezero chenichenicho sichikhoza kuwonetsedwa, ntchito yake yothandizira zaumoyo ikhoza kuwonetsedwa.

Mankhwala azitsamba zachilengedwe opangidwa ndi kugulitsidwa ku United States ali ndi udindo wovomerezeka, ndiko kuti, amavomerezedwa kuti agwiritsidwe ntchito popewa komanso kuchiza matenda.Mu 2000, poyankha zofuna za anthu, Purezidenti wa United States adaganiza zokhazikitsa "****** Policy Council on Complementary and Alternative Medicine", ndi mamembala a 20 omwe adasankhidwa ndi Purezidenti mwachindunji kuti akambirane ndondomeko za ndondomeko yothandizira. ndi chithandizo chamankhwala osagwiritsidwa ntchito m'malo ndikuwona phindu lake.Mu lipoti lake lovomerezeka kwa Purezidenti ndi Congress mu 2002, ****** idaphatikizanso "mankhwala achi China" m'dongosolo lamankhwala owonjezera ndi njira zina.

M'zaka zaposachedwa, FDA yalimbitsa kasamalidwe kamankhwala azitsamba zachilengedwe.Mu 2003, idayamba kugwiritsa ntchito kasamalidwe ka GMP pazowonjezera zakudya ndikukhazikitsa miyezo yokhazikika pakupanga ndi kulemba zolemba zazakudya zowonjezera.A FDA adasindikiza Malangizo a Kukula kwa Mankhwala Osokoneza Bongo pa intaneti ndikupempha ndemanga padziko lonse lapansi.Mfundo Zotsogolera zikuwonetsa bwino kuti mankhwala opangidwa ndi botanical ndi osiyana ndi mankhwala, kotero kuti zofunikira zawo zaukadaulo ziyeneranso kukhala zosiyana ndi zotsirizirazi, ndikufotokozeranso zina mwazinthu zamankhwala a botanical: kapangidwe kake ka mankhwala a botanical nthawi zambiri kumakhala kosakanikirana ndi zigawo zingapo, m'malo mwake. kuposa gulu limodzi;Si mankhwala onse omwe ali m'mankhwala azitsamba ****** omveka bwino;Nthawi zambiri, zosakaniza yogwira mankhwala azitsamba si anatsimikiza ******;Nthawi zina, kwachilengedwenso ntchito zomera mankhwala si ****** yotsimikizika ndi momveka;Njira zambiri zopangira ndi kukonza mankhwala azitsamba ndizothandiza kwambiri;Botanicals ali ndi chidziwitso chambiri komanso chanthawi yayitali pakugwiritsa ntchito anthu.Palibe zotsatira zoyipa zowoneka bwino zomwe zidapezeka pakugwiritsidwa ntchito kwanthawi yayitali komanso kwakukulu kwamankhwala azitsamba m'thupi la munthu.Mankhwala ena azitsamba akugulitsidwa ngati mankhwala kapena zakudya zowonjezera.

Kutengera kumvetsetsa kwa FDA kwa mankhwala a zomera, zofunikira zaumisiri za mankhwala a zomera mu Mfundo Zotsogola ndizosiyana ndi za mankhwala a mankhwala, kuphatikizapo: zofunikira zaumisiri pa kafukufuku wachipatala ndizotayirira;Kuyeza kwa pharmacokinetic kungathe kuchitidwa mosavuta.Special mankhwala pawiri mankhwala kukonzekera;Ukadaulo wamankhwala umafunikira kusintha kosinthika;Zofunikira zaukadaulo za pharmacology ndi toxicology zachepetsedwa.Maupangiri akuyimira kudumpha kwabwino pamachitidwe a FDA pamankhwala azitsamba achilengedwe, kuphatikiza mankhwala achi China.Kusintha kwakukulu kwa ndondomeko ya boma la America pa mankhwala azitsamba kwapangitsa kuti mankhwala azitsamba alowe mumsika waku America.
Kuphatikiza pa Veregen, yomwe yavomerezedwa kale, pafupifupi 60 mpaka 70 botanicals ali paipi mpaka pano.