H\u1ed3i x\u01b0a c\u00e1i m\u00f4n quy ch\u1ebf d\u01b0\u1ee3c hay m\u1ea5y b\u1ea1n hay k\u00eau ph\u00e1p d\u01b0\u1ee3c g\u00ec \u0111\u00f3 g\u1ecdi l\u00e0 D\u01b0\u1ee3c ch\u00ednh (kh\u00f4ng bi\u1ebft d\u01b0\u1ee3c ph\u1ee5 l\u00e0 c\u00e1i n\u00e0o).<\/p>\n
H\u1ecdc th\u00ec s\u01a1 s\u00e0i l\u1eafm, ch\u1ee7 y\u1ebfu h\u1ecdc cho bi\u1ebft thu\u1ed1c k\u00ea \u0111\u01a1n, \u0111\u1ed9c, nghi\u1ec7n, l\u1ecbch s\u1eed ng\u00e0nh y d\u01b0\u1ee3c n\u00e0y n\u1ecd th\u00f4i … ch\u1ee9 c\u0169ng kh\u00f4ng bi\u1ebft hay kh\u00f4ng \u0111\u1ec3 \u00fd CPP l\u00e0 c\u00e1i g\u00ec<\/strong>.<\/p>\n Sau \u0111i l\u00e0m Regu th\u00ec \u0111\u1eddi g\u1eafn li\u1ec1n CPP lu\u00f4n m\u00e0 s\u1ed1 sao \u0111\u00f3 t\u1eeb h\u1ed3i l\u00e0m t\u1edbi gi\u1edd ch\u01b0a t\u1eebng c\u00f3 s\u1ebfp Regu n\u00ean c\u1ee9 ph\u1ea3i m\u00e0y m\u00f2 t\u1eebng ch\u00fat.<\/p>\n M\u1edbi \u0111\u1ea7u \u0111\u1ecdc c\u00e1i CPP th\u00ec n\u00f3i thi\u1ec7t l\u00e0 coi ch\u1ed7 n\u00e0o c\u00f3 t\u00ean thu\u1ed1c, ho\u1ea1t ch\u1ea5t v\u00e0 t\u00ean nh\u00e0 s\u1ea3n xu\u1ea5t coi c\u00f3 kh\u1edbp xong l\u00e0 th\u00f4i. Bao nhi\u00eau th\u00f4ng tin tr\u00ean CPP b\u01b0ng i x\u00ec v\u00f4 \u0111\u01a1n \u0111\u0103ng k\u00fd. \u0110\u01a1n gi\u1ea3n m\u00e0, ch\u1ea3 sai khi n\u00e0o. <\/p>\n <\/p>\n <\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" H\u1ed3i x\u01b0a c\u00e1i m\u00f4n quy ch\u1ebf d\u01b0\u1ee3c hay m\u1ea5y b\u1ea1n hay k\u00eau ph\u00e1p d\u01b0\u1ee3c g\u00ec \u0111\u00f3 g\u1ecdi l\u00e0 D\u01b0\u1ee3c ch\u00ednh (kh\u00f4ng bi\u1ebft d\u01b0\u1ee3c ph\u1ee5 l\u00e0 c\u00e1i n\u00e0o). H\u1ecdc th\u00ec s\u01a1 s\u00e0i l\u1eafm, ch\u1ee7 y\u1ebfu h\u1ecdc cho bi\u1ebft thu\u1ed1c k\u00ea \u0111\u01a1n, \u0111\u1ed9c, nghi\u1ec7n, l\u1ecbch s\u1eed ng\u00e0nh y d\u01b0\u1ee3c n\u00e0y n\u1ecd th\u00f4i … ch\u1ee9 c\u0169ng kh\u00f4ng bi\u1ebft […]\n","protected":false},"author":1,"featured_media":5504,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-5502","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-y-te-suc-khoe"],"acf":[],"_links":{"self":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/5502","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/comments?post=5502"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/5502\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/5504"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=5502"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=5502"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=5502"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nSau n\u00e0y c\u00f3 quy \u0111\u1ecbnh l\u00e0 thu\u1ed1c ph\u1ea3i b\u00e1n \u1edf n\u01b0\u1edbc s\u1edf t\u1ea1i (kh\u00f4ng c\u00f3 tham chi\u1ebfu tham n\u1ec7m g\u00ec h\u1ebft), nh\u00e0 m\u00e1y ph\u1ea3i c\u00f3 GMP th\u00ec check th\u00eam c\u00e1i ph\u1ea7n GMP, marketed n\u1eefa th\u00f4i l\u00e0 xong.<\/p>\n
\nXong \u0111\u1ebfn h\u1ed3i l\u00e0m MNC th\u00ec c\u00f3 chuy\u1ec7n. M\u00ecnh y\u00eau c\u1ea7u CPP c\u00e1i h\u1eafn h\u1ecfi CPP 2B \u0111\u01b0\u1ee3c kh\u00f4ng? Cha 2B l\u00e0 g\u00ec ta? C\u00e1i m\u00ecnh l\u1ea7n \u0111\u1ea7u ti\u00ean ch\u0103m ch\u00fa ng\u1ed3i \u0111\u1ecdc t\u1eeb \u0111\u1ea7u \u0111\u1ebfn cu\u1ed1i kh\u00f4ng s\u00f3t ch\u1eef n\u00e0o c\u1ee7a c\u00e1i CPP, \u0111\u1ecdc s\u1ea1ch s\u1ebd lu\u00f4n ph\u1ea7n Notes. \u0110\u1ecdc xong ng\u1ed9 ra nhi\u1ec1u \u0111i\u1ec1u l\u1eafm, th\u1ea5y c\u00e1i CPP n\u00e0y hay gh\u00ea ta.
\nCho n\u00ean, l\u00e0m Regu, \u00edt nh\u1ea5t m\u1ed9t l\u1ea7n trong \u0111\u1eddi h\u00e3y \u0111\u1ecdc h\u1ebft t\u1eebng ch\u1eef c\u1ee7a m\u1ed9t c\u00e1i CPP.
\nNh\u01b0ng \u0111\u1ecdc h\u1ebft c\u0169ng kh\u00f4ng c\u00f3 ngh\u0129a l\u00e0 bi\u1ebft h\u1ebft, c\u00f2n l\u1eafm c\u00e1i v\u1ea5n \u0111\u1ec1 m\u00e0 \u0111\u1ee5ng r\u1ed3i m\u1edbi bi\u1ebft.
\nGi\u1ed1ng nh\u01b0 Asean variation guidelines, m\u00ecnh ngh\u0129 l\u00e0 c\u1ee7a Asean r\u1ed3i th\u00ec l\u00e0 n\u01b0\u1edbc n\u00e0o c\u0169ng x\u00e0i ch\u1ee9, nh\u01b0ng c\u00e1i Quy ch\u1ebf thay \u0111\u1ed5i c\u1ee7a VN n\u00f3 kh\u00e1c ch\u00fat ch\u00fat \u0111\u00f3.
\nCPP c\u0169ng v\u1eady, WHO th\u00ec hu ch\u1ee9 m\u1ed7i n\u01b0\u1edbc n\u00f3 bi\u1ebfn t\u1ea5u t\u00ed.
\nTh\u00ed d\u1ee5 Ph\u00e1p, thay v\u00ec t\u00ean nh\u00e0 SX, h\u1ecd l\u1ea1i \u0111\u1ec3 t\u00ean c\u00f4ng ty ch\u1ecbu tr\u00e1ch nhi\u1ec7m xu\u1ea5t x\u01b0\u1edfng l\u00f4 t\u1ea1i Ph\u00e1p, c\u00f2n nh\u00e0 s\u1ea3n xu\u1ea5t l\u00e0 ai, M\u1ef9 \u00dac g\u00ec c\u0169ng kh\u00f4ng c\u00f3 t\u00ean v\u00e0 v\u1eady th\u00ec ai s\u1ea3n xu\u1ea5t, ai \u0111\u00f3ng g\u00f3i c\u0169ng kh\u00f4ng c\u00f3 lu\u00f4n. Ngo\u00e0i ra n\u00f3 c\u00f2n \u0111\u00ednh k\u00e8m m\u1ed9t x\u1ea5p th\u00f4ng tin c\u1ea3 s\u01a1 y\u1ebfu l\u00fd l\u1ecbch v\u00e0 s\u1ea3n ph\u1ea9m b\u1eb1ng … ti\u1ebfng Ph\u00e1p, thi\u1ec7t l\u00e0 kh\u00f4ng c\u00f3 th\u00ec t\u1ed1t h\u01a1n.
\n\u00d4ng USFDA th\u00ec c\u00f3 m\u1ed7i m\u1ed9t trang (m\u1ea5y c\u00e1i kh\u00e1c cho v\u00f4 ph\u1ee5 l\u1ee5c), m\u00e0 \u0111\u1eb7c bi\u1ec7t \u1edf c\u00e1c n\u01b0\u1edbc th\u00ec \u0111\u1ecba ch\u1ec9 c\u00f3 nhi\u1ec1u c\u00e1ch vi\u1ebft, t\u00ean c\u00f4ng ty th\u00ec vi\u1ebft nguy\u00ean vi\u1ebft t\u1eaft n\u00e0y n\u1ecd n\u00ean kh\u00f4ng c\u1ea9n th\u1eadn l\u00e0 kh\u00e1c nhau th\u00ec ch\u1ebft v\u1edbi c\u00e1c b\u00e1c.
\nCPP nh\u1eadt th\u00ec th\u00f4i l\u00e0 \u00e1c m\u1ed9ng nh\u1ea5t trong tr\u01b0\u1eddng h\u1ee3p c\u00f3 nhi\u1ec1u nh\u00e0 s\u1ea3n xu\u1ea5t tham gia, kh\u00f4ng c\u00e1ch g\u00ec m\u00e0 th\u00eam v\u00f4 \u0111\u01b0\u1ee3c v\u00ec c\u00e1i form n\u00f3 c\u1ee9ng ng\u1eafc, th\u00eam nh\u00e0 n\u00e0y th\u00ec thi\u1ebfu nh\u00e0 kia. Regu Japan n\u00f3i sao? \u00c0, c\u0169ng bi\u1ebft l\u00e0 v\u1eady kh\u00f4ng \u0111\u00fang nh\u01b0ng kh\u00f4ng c\u00f3 c\u00e1ch thuy\u1ebft ph\u1ee5c c\u00e1c b\u00e1c c\u1ee7a h\u1ecd.
\nCPP c\u1ee7a ch\u00e2u \u00c2u – EMA n\u00f3i chung l\u00e0 \u1ed5n, ch\u1ec9 c\u00f3 \u0111i\u1ec1u n\u00f3 s\u1ebd ghi t\u00ean cty xu\u1ea5t x\u01b0\u1edfng l\u00f4 t\u1ea1i EU – b\u1eaft bu\u1ed9c – m\u00e0 n\u1ebfu xu\u1ea5t x\u01b0\u1edfng cho VN l\u00e0 m\u1ed9t c\u00f4ng ty kh\u00e1c l\u00e0 c\u00e1c b\u00e1c m\u00ecnh l\u1ea1i v\u1eb7n.
\nC\u00f2n nhi\u1ec1u v\u1ea5n \u0111\u1ec1 n\u1eefa nh\u01b0 l\u00e0 c\u00f4ng \u0111o\u1ea1n \u0111\u00f3 kh\u00f4ng x\u1ea3y ra \u1edf n\u01b0\u1edbc c\u1ea5p CPP th\u00ec h\u1ecd kh\u00f4ng cho NSX \u0111\u00f3 v\u00e0o CPP \u0111\u00f3 \u0111\u01b0\u1ee3c. Th\u00ed d\u1ee5 sx \u1edf M\u1ef9, \u0111\u00f3ng g\u00f3i n\u01b0\u1edbc kh\u00e1c, CPP M\u1ef9 kh\u00f4ng c\u00f3 cty \u0111\u00f3ng g\u00f3i v\u00ec c\u00e1i b\u00e1n \u1edf M\u1ef9 \u0111\u00f3ng g\u00f3i \u1edf M\u1ef9. \u00c0, th\u00ec l\u1ea5y CPP n\u01b0\u1edbc \u0111\u00f3ng g\u00f3i. \u00c0, \u0111\u00f3ng g\u00f3i gia c\u00f4ng, kh\u00f4ng b\u00e1n \u1edf n\u01b0\u1edbc \u0111\u00f3ng g\u00f3i n\u00ean kh\u00f4ng \u0111\u0103ng k\u00fd thu\u1ed1c, kh\u00f4ng c\u00f3 CPP.
\nKinh kh\u1ee7ng nh\u1ea5t l\u00e0 ch\u00fang ta b\u00ea nh\u1eefng th\u00f4ng tin tr\u00ean CPP cho v\u00e0o \u0111\u01a1n \u0111\u0103ng k\u00fd l\u00e0 NSX t\u1ea5t c\u1ea3 c\u00e1c c\u00f4ng \u0111o\u1ea1n nh\u01b0ng th\u1eadt ra ch\u1ec9 c\u00f3 m\u1ed7i vi\u1ec7c final release. Kinh kh\u1ee7ng sao th\u00ec c\u00e1c b\u1ea1n bi\u1ebft r\u1ed3i \u0111\u00f3. S\u1ea3n xu\u1ea5t kh\u00f4ng \u0111\u00fang v\u1edbi h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd – l\u00ean th\u1edbt.
\nCho n\u00ean, khi l\u00e0m h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd, ph\u1ea3i l\u00e0m c\u00e1i check list cho CPP, ch\u00fa th\u00edch k\u1ef9 t\u1eebng y\u00eau c\u1ea7u theo QUY \u0110\u1ecaNH CPP c\u1ee7a VN. Ghi th\u1eadt k\u1ef9 l\u00e0 T\u00ean NSX, \u0111\u1ecba ch\u1ec9 th\u00ec g\u1ed3m nh\u1eefng nh\u00e0 n\u00e0o, GMP th\u1ebf n\u00e0o, n\u1ebfu c\u00f3 NSX kh\u00f4ng n\u1eb1m trong n\u01b0\u1edbc \u0111\u00f3 tham gia m\u1ed9t c\u00f4ng \u0111o\u1ea1n n\u00e0o \u0111\u00f3 th\u00ec ph\u1ea3i cung c\u1ea5p GMP…, h\u1ee3p ph\u00e1p ho\u00e1 th\u1ebf n\u00e0o, c\u00f4ng th\u1ee9c c\u1ea3 ho\u1ea1t ch\u1ea5t v\u00e0 t\u00e1 d\u01b0\u1ee3c, quy c\u00e1ch \u0111\u00f3ng g\u00f3i… \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o c\u00e1i CPP g\u1eedi v\u1ec1 n\u00f3 \u0111\u1ee7 v\u00e0 \u0111\u00fang (he he m\u00e0 c\u00f3 khi v\u1eabn sai \u0111\u1ea5y)
\nNgo\u00e0i ra, \u0111\u1ec3 tr\u00e1nh c\u00e1c sai s\u00f3t, ch\u00fang ta n\u00ean l\u00e0m c\u00e1i x\u00e1c nh\u1eadn v\u1edbi c\u00e1c b\u1ea1n \u1ea5y v\u1ec1 nh\u1eefng th\u00f4ng tin m\u00e0 ch\u00fang ta s\u1ebd cho v\u00e0o \u0111\u01a1n \u0111\u0103ng k\u00fd, \u0111\u1ec3 tr\u00e1nh sai s\u00f3t v\u00e0 c\u00f3 \u0111\u1ed3ng thu\u1eadn c\u0169ng nh\u01b0 bi\u1ebft tr\u01b0\u1edbc nh\u1eefng kh\u00f3 kh\u0103n hay nh\u1eefng c\u00e1i kh\u00f4ng l\u00e0m \u0111\u01b0\u1ee3c do quy \u0111\u1ecbnh kh\u00e1c nhau \u1edf m\u1ed7i n\u01b0\u1edbc m\u00e0 c\u00f3 c\u00e1ch gi\u1ea3i quy\u1ebft, gi\u1ea3i tr\u00ecnh. Sai g\u00ec ch\u1ee9 sai NSX th\u00ec ch\u1ec9 c\u00f3… b\u1ecf.
\nN\u00f3i chung, CPP y\u00eau nh\u1ea5t v\u1eabn l\u00e0 CPP EMA, g\u00ec c\u0169ng c\u00f3, lu\u00f4n c\u1ea3 SmPC v\u00e0 mu\u1ed1n th\u00eam \u0111\u1ee7 th\u00f4ng tin s\u1ea3n xu\u1ea5t, \u0111\u00f3ng g\u00f3i, xu\u1ea5t x\u01b0\u1edfng g\u00ec cho VN c\u0169ng c\u00f3 th\u1ec3 l\u00e0m \u0111\u01b0\u1ee3c h\u1ebft.
\nL\u00e0m Regu thu\u1ed1c n\u01b0\u1edbc ngo\u00e0i, quan tr\u1ecdng l\u00e0 \u0111\u1eebng t\u1ef1 t\u01b0\u1edfng t\u01b0\u1edfng quy \u0111inh n\u01b0\u1edbc m\u00ecnh gi\u1ed1ng n\u01b0\u1edbc ng\u01b0\u1eddi ta, c\u00f3 \u0111i\u1ec1u ki\u1ec7n th\u00ec n\u00ean h\u1ecfi \u0111\u1ec3 tr\u00e1nh hi\u1ec3u nh\u1ea7m v\u00e0 c\u0169ng nh\u01b0 c\u00f3 c\u01a1 h\u1ed9i h\u1ecdc h\u1ecfi th\u00eam.<\/p>\n