{"id":9145,"date":"2026-02-05T08:23:06","date_gmt":"2026-02-05T08:23:06","guid":{"rendered":"https:\/\/sepro.vn\/?p=9145"},"modified":"2026-02-05T08:23:06","modified_gmt":"2026-02-05T08:23:06","slug":"ema-la-gi-vai-tro-quy-trinh-tra-cuu-thuoc-eu","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/ema-la-gi-vai-tro-quy-trinh-tra-cuu-thuoc-eu\/","title":{"rendered":"EMA l\u00e0 g\u00ec? Vai tr\u00f2, quy tr\u00ecnh v\u00e0 c\u00e1ch tra c\u1ee9u thu\u1ed1c t\u1ea1i EU"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">N\u1ebfu b\u1ea1n \u0111ang t\u00ecm m\u1ed9t \u0111\u1ecbnh ngh\u0129a r\u00f5 r\u00e0ng v\u1ec1 <strong><a href=\"https:\/\/sepro.vn\/\/ema-la-gi-vai-tro-quy-trinh-tra-cuu-thuoc-eu\/\">EMA<\/a><\/strong>, mu\u1ed1n hi\u1ec3u EMA tham gia th\u1ebf n\u00e0o trong quy tr\u00ecnh c\u1ea5p ph\u00e9p thu\u1ed1c t\u1ea1i EU v\u00e0 c\u1ea7n c\u00e1c \u0111\u1ecba ch\u1ec9 tra c\u1ee9u ch\u00ednh th\u1ed1ng nh\u01b0 EPAR ,Adrreports v\u00e0 CTIS, b\u00e0i n\u00e0y s\u1ebd gi\u00fap b\u1ea1n n\u1eafm nhanh trong v\u00e0i ph\u00fat.<\/span><\/p>\n<h2><b>T\u1ed5 ch\u1ee9c EMA l\u00e0 g\u00ec? Vai tr\u00f2, quy tr\u00ecnh v\u00e0 c\u00e1ch tra c\u1ee9u th\u00f4ng tin thu\u1ed1c t\u1ea1i EU<\/b><\/h2>\n<figure id=\"attachment_9146\" aria-describedby=\"caption-attachment-9146\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-9146\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-1.png\" alt=\"ema-la-gi\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-1.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-1-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-1-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/2-1-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9146\" class=\"wp-caption-text\"><em>EMA l\u00e0 g\u00ec<\/em><\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">EMA l\u00e0 C\u01a1 quan D\u01b0\u1ee3c ph\u1ea9m Ch\u00e2u \u00c2u, n\u01a1i t\u1eadp trung chuy\u00ean m\u00f4n khoa h\u1ecdc \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 v\u00e0 gi\u00e1m s\u00e1t thu\u1ed1c trong h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd thu\u1ed1c c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u. N\u1ebfu b\u1ea1n c\u1ea7n hi\u1ec3u thu\u1ed1c \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 ra sao tr\u01b0\u1edbc khi l\u01b0u h\u00e0nh, sau khi l\u01b0u h\u00e0nh \u0111\u01b0\u1ee3c theo d\u00f5i th\u1ebf n\u00e0o, ho\u1eb7c mu\u1ed1n tra c\u1ee9u th\u00f4ng tin thu\u1ed1c v\u00e0 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng t\u1ea1i EU, EMA l\u00e0 \u0111i\u1ec3m xu\u1ea5t ph\u00e1t \u0111\u00e1ng tin c\u1eady.<\/span><\/p>\n<h2><b>EMA l\u00e0 g\u00ec, ch\u1ecbu tr\u00e1ch nhi\u1ec7m g\u00ec?<\/b><\/h2>\n<figure id=\"attachment_9148\" aria-describedby=\"caption-attachment-9148\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9148\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-1.png\" alt=\"co-quan-duoc-pham-ema\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-1.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-1-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-1-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/3-1-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9148\" class=\"wp-caption-text\"><em>C\u01a1 quan \u0111\u01b0\u1ee3c ph\u1ea9m EMA<\/em><\/figcaption><\/figure>\n<h3><b>EMA l\u00e0 c\u01a1 quan n\u00e0o trong h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd thu\u1ed1c ch\u00e2u \u00c2u<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">EMA l\u00e0 c\u01a1 quan c\u1ee7a EU th\u00fac \u0111\u1ea9y ch\u1ea5t l\u01b0\u1ee3ng \u0111\u00e1nh gi\u00e1 khoa h\u1ecdc v\u00e0 ho\u1ea1t \u0111\u1ed9ng gi\u00e1m s\u00e1t thu\u1ed1c, ph\u1ee5c v\u1ee5 s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng v\u00e0 th\u00fa y trong EU. EMA kh\u00f4ng ho\u1ea1t \u0111\u1ed9ng \u0111\u01a1n l\u1ebb m\u00e0 ph\u1ed1i h\u1ee3p c\u00f9ng m\u1ea1ng l\u01b0\u1edbi c\u01a1 quan qu\u1ea3n l\u00fd thu\u1ed1c c\u1ee7a c\u00e1c qu\u1ed1c gia th\u00e0nh vi\u00ean \u0111\u1ec3 ra khuy\u1ebfn ngh\u1ecb khoa h\u1ecdc v\u00e0 tri\u1ec3n khai gi\u00e1m s\u00e1t an to\u00e0n.<\/span><\/p>\n<h3><b>EMA ch\u1ecbu tr\u00e1ch nhi\u1ec7m g\u00ec<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Tr\u01b0\u1edbc khi m\u1ed9t lo\u1ea1i thu\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh theo c\u01a1 ch\u1ebf c\u1ea5p ph\u00e9p chung cho to\u00e0n Li\u00ean minh ch\u00e2u \u00c2u (centralised procedure, th\u01b0\u1eddng g\u1ecdi l\u00e0 th\u1ee7 t\u1ee5c t\u1eadp trung), C\u01a1 quan D\u01b0\u1ee3c ph\u1ea9m ch\u00e2u \u00c2u (European Medicines Agency, EMA) t\u1ed5 ch\u1ee9c \u0111\u00e1nh gi\u00e1 h\u1ed3 s\u01a1 thu\u1ed1c tr\u00ean g\u00f3c \u0111\u1ed9 khoa h\u1ecdc cho to\u00e0n b\u1ed9 h\u1ed3 s\u01a1 xin c\u1ea5p ph\u00e9p.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Trong ph\u1ea7n n\u00e0y, \u1ee6y ban Thu\u1ed1c d\u00f9ng cho ng\u01b0\u1eddi (Committee for Medicinal Products for Human Use, CHMP) l\u00e0 \u0111\u01a1n v\u1ecb ch\u1ecbu tr\u00e1ch nhi\u1ec7m \u0111\u00e1nh gi\u00e1 ch\u00ednh. CHMP xem x\u00e9t d\u1eef li\u1ec7u v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng, hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n, sau \u0111\u00f3 ban h\u00e0nh \u00fd ki\u1ebfn khoa h\u1ecdc v\u00e0 khuy\u1ebfn ngh\u1ecb ch\u00ednh th\u1ee9c g\u1eedi l\u00ean \u1ee6y ban ch\u00e2u \u00c2u v\u1ec1 vi\u1ec7c c\u00f3 n\u00ean c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh cho to\u00e0n EU hay kh\u00f4ng.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Sau khi thu\u1ed1c \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p v\u00e0 \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng, tr\u1ecdng t\u00e2m chuy\u1ec3n sang gi\u00e1m s\u00e1t an to\u00e0n trong qu\u00e1 tr\u00ecnh s\u1eed d\u1ee5ng th\u1ef1c t\u1ebf. EMA \u0111i\u1ec1u ph\u1ed1i h\u1ec7 th\u1ed1ng c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c c\u1ee7a EU theo khung ph\u00e1p lu\u1eadt chung, \u0111\u1ed3ng th\u1eddi v\u1eadn h\u00e0nh c\u00e1c quy tr\u00ecnh v\u00e0 c\u00f4ng c\u1ee5 \u0111\u1ec3 ph\u00e1t hi\u1ec7n t\u00edn hi\u1ec7u an to\u00e0n, \u0111\u00e1nh gi\u00e1 r\u1ee7i ro v\u00e0 \u0111\u1ec1 xu\u1ea5t bi\u1ec7n ph\u00e1p qu\u1ea3n l\u00fd r\u1ee7i ro.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u1ede giai \u0111o\u1ea1n n\u00e0y, \u1ee6y ban \u0110\u00e1nh gi\u00e1 r\u1ee7i ro v\u1ec1 C\u1ea3nh gi\u00e1c d\u01b0\u1ee3c (Pharmacovigilance Risk Assessment Committee, PRAC) ph\u1ee5 tr\u00e1ch ph\u1ea7n \u0111\u00e1nh gi\u00e1 an to\u00e0n: th\u1ea9m \u0111\u1ecbnh t\u00edn hi\u1ec7u an to\u00e0n, xem x\u00e9t d\u1eef li\u1ec7u v\u00e0 \u0111\u01b0a ra khuy\u1ebfn ngh\u1ecb nh\u01b0 c\u1eadp nh\u1eadt c\u1ea3nh b\u00e1o, \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin s\u1ea3n ph\u1ea9m, b\u1ed5 sung y\u00eau c\u1ea7u theo d\u00f5i, ho\u1eb7c c\u00e1c bi\u1ec7n ph\u00e1p qu\u1ea3n l\u00fd r\u1ee7i ro ph\u00f9 h\u1ee3p.<\/span><\/p>\n<h3><b>Vai tr\u00f2 c\u1ee7a EMA kh\u00e1c g\u00ec so v\u1edbi c\u01a1 quan c\u1ea5p ph\u00e9p<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">C\u01a1 quan D\u01b0\u1ee3c ph\u1ea9m ch\u00e2u \u00c2u (European Medicines Agency, EMA) ch\u1ecbu tr\u00e1ch nhi\u1ec7m \u0111\u00e1nh gi\u00e1 h\u1ed3 s\u01a1 thu\u1ed1c tr\u00ean g\u00f3c \u0111\u1ed9 khoa h\u1ecdc, t\u1ee9c l\u00e0 xem x\u00e9t v\u00e0 k\u1ebft lu\u1eadn d\u1ef1a tr\u00ean d\u1eef li\u1ec7u v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng, hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a thu\u1ed1c trong th\u1ee7 t\u1ee5c. Quy\u1ebft \u0111\u1ecbnh c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh \u1edf c\u1ea5p Li\u00ean minh ch\u00e2u \u00c2u thu\u1ed9c th\u1ea9m quy\u1ec1n c\u1ee7a \u1ee6y ban ch\u00e2u \u00c2u (European Commission). Khi \u1ee6y ban ch\u00e2u \u00c2u c\u1ea5p ph\u00e9p, gi\u1ea5y ph\u00e9p c\u00f3 hi\u1ec7u l\u1ef1c tr\u00ean to\u00e0n EU v\u00e0 \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn t\u1ea1i c\u00e1c n\u01b0\u1edbc thu\u1ed9c Khu v\u1ef1c Kinh t\u1ebf ch\u00e2u \u00c2u (European Economic Area, EEA) theo quy \u0111\u1ecbnh li\u00ean quan.<\/span><\/p>\n<h3><b>C\u00e1c ngu\u1ed3n th\u00f4ng tin ch\u00ednh th\u1ed1ng c\u1ee7a EMA n\u00ean bi\u1ebft<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Ba ngu\u1ed3n ch\u00ednh th\u1ed1ng d\u1ec5 d\u00f9ng nh\u1ea5t, ph\u1ee5c v\u1ee5 tra c\u1ee9u thu\u1ed1c, an to\u00e0n thu\u1ed1c v\u00e0 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Trang Medicines v\u00e0 EPAR \u0111\u1ec3 tra thu\u1ed1c, xem h\u1ed3 s\u01a1 \u0111\u00e1nh gi\u00e1 c\u00f4ng khai v\u00e0 t\u00e0i li\u1ec7u s\u1ea3n ph\u1ea9m<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Adrreports.eu \u0111\u1ec3 tra b\u00e1o c\u00e1o ph\u1ea3n \u1ee9ng c\u00f3 h\u1ea1i nghi ng\u1edd trong EEA<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CTIS public website \u0111\u1ec3 tra th\u00f4ng tin th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng t\u1ea1i EU v\u00e0 EEA<\/span><\/li>\n<\/ul>\n<p><strong><em>Tham kh\u1ea3o th\u00eam t\u1ea1i:<\/em><\/strong><\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.ema.europa.eu\/en\/medicines<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/what-we-publish-medicines-when\/european-public-assessment-reports-background-context\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.ema.europa.eu\/en\/medicines\/what-we-publish-medicines-when\/european-public-assessment-reports-background-context<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.adrreports.eu\/en\/index.html\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.adrreports.eu\/en\/index.html<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/clinical-trials-human-medicines\/clinical-trials-information-system\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/clinical-trials-human-medicines\/clinical-trials-information-system<\/span><\/a><\/p>\n<h2><b>EMA l\u00e0m g\u00ec trong v\u00f2ng \u0111\u1eddi thu\u1ed1c<\/b><\/h2>\n<figure id=\"attachment_9152\" aria-describedby=\"caption-attachment-9152\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9152\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-1.png\" alt=\"ema-lam-gi-trong-vong-doi-thuoc\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-1.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-1-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-1-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/5-1-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9152\" class=\"wp-caption-text\"><em>EMA l\u00e0m g\u00ec trong v\u00f2ng \u0111\u1eddi thu\u1ed1c<\/em><\/figcaption><\/figure>\n<h3><b>Giai \u0111o\u1ea1n nghi\u00ean c\u1ee9u v\u00e0 ph\u00e1t tri\u1ec3n<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Trong giai \u0111o\u1ea1n tr\u01b0\u1edbc n\u1ed9p h\u1ed3 s\u01a1 c\u1ea5p ph\u00e9p, EMA c\u00f3 c\u00e1c n\u1ed9i dung h\u01b0\u1edbng d\u1eabn v\u00e0 \u0111\u1ecbnh h\u01b0\u1edbng ti\u1ec1n th\u1ea9m \u0111\u1ecbnh gi\u00fap doanh nghi\u1ec7p chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1 ph\u00f9 h\u1ee3p k\u1ef3 v\u1ecdng c\u1ee7a EU, \u0111\u1eb7c bi\u1ec7t v\u1edbi c\u00e1c ch\u1ee7 \u0111\u1ec1 th\u01b0\u1eddng ph\u00e1t sinh trong giai \u0111o\u1ea1n n\u1ed9p h\u1ed3 s\u01a1.<\/span><\/p>\n<h3><b>Quy tr\u00ecnh \u0111\u00e1nh gi\u00e1 thu\u1ed1c c\u1ee7a EMA<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">V\u1edbi thu\u1ed1c d\u00f9ng cho ng\u01b0\u1eddi trong th\u1ee7 t\u1ee5c, CHMP l\u00e0 \u1ee7y ban \u0111\u00e1nh gi\u00e1 h\u1ed3 s\u01a1 v\u00e0 \u0111\u01b0a ra khuy\u1ebfn ngh\u1ecb c\u1ea5p ph\u00e9p hay kh\u00f4ng c\u1ea5p ph\u00e9p. Quy tr\u00ecnh \u0111\u00e1nh gi\u00e1 theo timeline c\u00f3 c\u00e1c m\u1ed1c l\u00e0m r\u00f5 c\u00e2u h\u1ecfi, ph\u1ea3n h\u1ed3i b\u1ed5 sung d\u1eef li\u1ec7u v\u00e0 k\u1ebft lu\u1eadn l\u1ee3i \u00edch nguy c\u01a1.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">N\u1ebfu b\u1ea1n c\u1ea7n gi\u1ea3i th\u00edch r\u00f5 EMA \u0111\u00e1nh gi\u00e1 nh\u1eefng g\u00ec, c\u00f3 th\u1ec3 hi\u1ec3u theo 3 m\u1ee5c nh\u01b0 sau:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ch\u1ea5t l\u01b0\u1ee3ng: thu\u1ed1c c\u00f3 \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t \u1ed5n \u0111\u1ecbnh, ki\u1ec3m so\u00e1t t\u1ea1p ch\u1ea5t, ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng ph\u00f9 h\u1ee3p hay kh\u00f4ng<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">An to\u00e0n: nguy c\u01a1 v\u00e0 t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n \u0111\u00e3 \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3, qu\u1ea3n l\u00fd r\u1ee7i ro nh\u01b0 th\u1ebf n\u00e0o<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Hi\u1ec7u qu\u1ea3: b\u1eb1ng ch\u1ee9ng l\u00e2m s\u00e0ng c\u00f3 \u0111\u1ee7 \u0111\u1ec3 ch\u1ee9ng minh l\u1ee3i \u00edch cho ch\u1ec9 \u0111\u1ecbnh d\u1ef1 ki\u1ebfn hay kh\u00f4ng<\/span><\/li>\n<\/ul>\n<h3><b>Quy tr\u00ecnh c\u1ea5p ph\u00e9p thu\u1ed1c t\u1ea1i EU<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Doanh nghi\u1ec7p n\u1ed9p h\u1ed3 s\u01a1 tr\u1ef1c ti\u1ebfp cho EMA th\u1ef1c hi\u1ec7n ki\u1ec3m tra t\u00ednh h\u1ee3p l\u1ec7 v\u00e0 \u0111\u00e1nh gi\u00e1 khoa h\u1ecdc. Sau khi CHMP ra \u00fd ki\u1ebfn khoa h\u1ecdc, \u1ee6y ban Ch\u00e2u \u00c2u l\u00e0 b\u00ean ra quy\u1ebft \u0111\u1ecbnh c\u1ea5p ph\u00e9p cu\u1ed1i c\u00f9ng.<\/span><\/p>\n<h3><b>T\u00e0i li\u1ec7u c\u00f4ng khai sau khi \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">N\u1ebfu thu\u1ed1c \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn, EMA c\u00f4ng b\u1ed1 <strong><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/what-we-publish-medicines-when\/european-public-assessment-reports-background-context\" target=\"_blank\" rel=\"noopener\">EPAR<\/a><\/strong>. \u0110\u00e2y kh\u00f4ng ch\u1ec9 l\u00e0 m\u1ed9t t\u1ec7p \u0111\u01a1n l\u1ebb m\u00e0 l\u00e0 b\u1ed9 th\u00f4ng tin g\u1ed3m nhi\u1ec1u th\u00e0nh ph\u1ea7n t\u00e0i li\u1ec7u, gi\u00fap ng\u01b0\u1eddi \u0111\u1ecdc hi\u1ec3u c\u01a1 s\u1edf \u0111\u00e1nh gi\u00e1 v\u00e0 c\u00e1c quy\u1ebft \u0111\u1ecbnh ch\u00ednh v\u1ec1 l\u1ee3i \u00edch nguy c\u01a1, \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng v\u00e0 c\u1ea3nh b\u00e1o.<\/span><\/p>\n<h2><b>EMA theo d\u00f5i thu\u1ed1c nh\u01b0 th\u1ebf n\u00e0o sau khi c\u1ea5p ph\u00e9p<\/b><\/h2>\n<figure id=\"attachment_9150\" aria-describedby=\"caption-attachment-9150\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9150\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-1.png\" alt=\"ema-theo-doi-thuoc-nhu-the-nao-khi-cap-phep\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-1.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-1-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-1-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/02\/4-1-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9150\" class=\"wp-caption-text\"><em>EMA theo d\u00f5i thu\u1ed1c nh\u01b0 th\u1ebf n\u00e0o khi c\u1ea5p ph\u00e9p<\/em><\/figcaption><\/figure>\n<h3><b>Pharmacovigilance l\u00e0 g\u00ec trong b\u1ed1i c\u1ea3nh EU<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Pharmacovigilance l\u00e0 h\u1ec7 th\u1ed1ng ph\u00e1t hi\u1ec7n, \u0111\u00e1nh gi\u00e1, hi\u1ec3u v\u00e0 ph\u00f2ng ng\u1eeba t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n ho\u1eb7c v\u1ea5n \u0111\u1ec1 li\u00ean quan \u0111\u1ebfn thu\u1ed1c. EMA \u0111i\u1ec1u ph\u1ed1i c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c \u1edf c\u1ea5p EU v\u00e0 v\u1eadn h\u00e0nh c\u00e1c d\u1ecbch v\u1ee5, quy tr\u00ecnh theo lu\u1eadt EU.<\/span><\/p>\n<h3><b>Gi\u00e1m s\u00e1t sau l\u01b0u h\u00e0nh v\u00e0 qu\u1ea3n l\u00fd r\u1ee7i ro<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Sau khi thu\u1ed1c c\u00f3 gi\u1ea5y ph\u00e9p, h\u1ec7 th\u1ed1ng ti\u1ebfp t\u1ee5c theo d\u00f5i d\u1eef li\u1ec7u th\u1ef1c t\u1ebf, \u0111\u00e1nh gi\u00e1 c\u00e2n b\u1eb1ng l\u1ee3i \u00edch nguy c\u01a1 v\u00e0 c\u1eadp nh\u1eadt bi\u1ec7n ph\u00e1p gi\u1ea3m thi\u1ec3u r\u1ee7i ro khi c\u1ea7n. C\u00e1c n\u1ed9i dung n\u00e0y \u0111\u01b0\u1ee3c t\u1ed5 ch\u1ee9c theo khung c\u00f4ng vi\u1ec7c c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c v\u00e0 c\u00e1c quy tr\u00ecnh li\u00ean quan \u0111\u1ebfn EudraVigilance.<\/span><\/p>\n<h3><b>T\u00edn hi\u1ec7u an to\u00e0n thu\u1ed1c l\u00e0 g\u00ec v\u00e0 x\u1eed l\u00fd ra sao<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">T\u00edn hi\u1ec7u an to\u00e0n l\u00e0 d\u1ea5u hi\u1ec7u g\u1ee3i \u00fd m\u1ed9t m\u1ed1i nguy m\u1edbi ho\u1eb7c thay \u0111\u1ed5i b\u1ea3n ch\u1ea5t c\u1ee7a nguy \u0111\u00e3 bi\u1ebft, xu\u1ea5t ph\u00e1t t\u1eeb d\u1eef li\u1ec7u b\u00e1o c\u00e1o ho\u1eb7c d\u1eef li\u1ec7u kh\u00e1c. EMA duy tr\u00ec h\u01b0\u1edbng d\u1eabn v\u00e0 quy tr\u00ecnh \u0111\u1ec3 qu\u1ea3n l\u00fd t\u00edn hi\u1ec7u trong h\u1ec7 th\u1ed1ng c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c c\u1ee7a EU.<\/span><\/p>\n<h3><b>C\u00e1ch tra c\u1ee9u ph\u1ea3n \u1ee9ng c\u00f3 h\u1ea1i c\u1ee7a thu\u1ed1c<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Adrreports.eu l\u00e0 c\u1ed5ng d\u1eef li\u1ec7u c\u00f4ng khai cho ph\u00e9p xem b\u00e1o c\u00e1o ph\u1ea3n \u1ee9ng c\u00f3 h\u1ea1i nghi ng\u1edd c\u1ee7a thu\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p trong EEA. B\u1ea1n c\u00f3 th\u1ec3 tra theo t\u00ean thu\u1ed1c ho\u1eb7c theo ho\u1ea1t ch\u1ea5t, t\u00f9y lo\u1ea1i thu\u1ed1c v\u00e0 ph\u1ea1m vi c\u1ea5p ph\u00e9p.<\/span><\/p>\n<h2><b>Khi n\u00e0o b\u1ea1n c\u1ea7n quan t\u00e2m EMA<\/b><\/h2>\n<h3><b>Khi c\u1ea7n tra c\u1ee9u thu\u1ed1c tr\u00ean EMA<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">Khi b\u1ea1n c\u1ea7n th\u00f4ng tin chu\u1ea9n v\u1ec1 thu\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p theo th\u1ee7 t\u1ee5c t\u1eadp trung, h\u00e3y tra trong m\u1ee5c Medicines c\u1ee7a EMA \u0111\u1ec3 xem t\u00ecnh tr\u1ea1ng c\u1ea5p ph\u00e9p, t\u00e0i li\u1ec7u s\u1ea3n ph\u1ea9m v\u00e0 EPAR.<\/span><\/p>\n<h3><b>Khi l\u00e0m \u0111\u0103ng k\u00fd thu\u1ed1c ho\u1eb7c \u0111\u00e1nh gi\u00e1 c\u01a1 h\u1ed9i v\u00e0o th\u1ecb tr\u01b0\u1eddng EU<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">N\u1ebfu b\u1ea1n l\u00e0m RA, BD ho\u1eb7c chi\u1ebfn l\u01b0\u1ee3c th\u1ecb tr\u01b0\u1eddng, EMA gi\u00fap b\u1ea1n hi\u1ec3u \u0111\u01b0\u1eddng \u0111i c\u1ee7a h\u1ed3 s\u01a1 theo th\u1ee7 t\u1ee5c t\u1eadp trung v\u00e0 nh\u1eefng g\u00ec \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 sau c\u1ea5p ph\u00e9p. V\u1edbi b\u1ee9c tranh t\u1ed5ng quan, b\u1ea1n c\u00f3 th\u1ec3 \u0111\u1ecbnh v\u1ecb d\u1eef li\u1ec7u c\u1ea7n chu\u1ea9n b\u1ecb v\u00e0 c\u00e1ch \u0111\u1ed1i chi\u1ebfu th\u00f4ng tin c\u00f4ng khai.<\/span><\/p>\n<h3><b>Khi l\u00e0m th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng t\u1ea1i EU<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">N\u1ebfu b\u1ea1n l\u00e0m nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng, CTIS l\u00e0 h\u1ec7 th\u1ed1ng n\u1ed9p h\u1ed3 s\u01a1, ph\u00ea duy\u1ec7t v\u00e0 gi\u00e1m s\u00e1t th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng t\u1ea1i EU v\u00e0 EEA theo Clinical Trials Regulation. \u0110\u1ed3ng th\u1eddi c\u00f3 public website \u0111\u1ec3 b\u1ea5t k\u1ef3 ai c\u0169ng c\u00f3 th\u1ec3 t\u00ecm ki\u1ebfm th\u00f4ng tin th\u1eed nghi\u1ec7m.<\/span><\/p>\n<h3><b>Khi theo d\u00f5i an to\u00e0n thu\u1ed1c sau l\u01b0u h\u00e0nh<\/b><\/h3>\n<p><span style=\"font-weight: 400;\">N\u1ebfu b\u1ea1n l\u00e0m d\u01b0\u1ee3c l\u00e2m s\u00e0ng, c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c, ho\u1eb7c theo d\u00f5i th\u00f4ng tin thu\u1ed1c, adrreports.eu v\u00e0 c\u00e1c trang c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c c\u1ee7a EMA l\u00e0 n\u01a1i \u0111\u1ec3 n\u1eafm d\u1eef li\u1ec7u b\u00e1o c\u00e1o ADR v\u00e0 c\u1eadp nh\u1eadt c\u00e1c n\u1ed9i dung li\u00ean quan gi\u00e1m s\u00e1t an to\u00e0n.<\/span><\/p>\n<h2><b>FAQ tham kh\u1ea3o v\u1ec1 EMA<\/b><\/h2>\n<h3><strong>EMA c\u00f3 ph\u1ea3i l\u00e0 c\u01a1 quan c\u1ea5p ph\u00e9p thu\u1ed1c \u1edf ch\u00e2u \u00c2u kh\u00f4ng ?<\/strong><\/h3>\n<p><span style=\"font-weight: 400;\">EMA \u0111\u00e1nh gi\u00e1 khoa h\u1ecdc v\u00e0 ra \u00fd ki\u1ebfn trong th\u1ee7 t\u1ee5c t\u1eadp trung; quy\u1ebft \u0111\u1ecbnh c\u1ea5p ph\u00e9p \u1edf c\u1ea5p EU do \u1ee6y ban Ch\u00e2u \u00c2u ban h\u00e0nh.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/p>\n<h3><strong>EPAR l\u00e0 g\u00ec v\u00e0 \u0111\u1ecdc \u0111\u1ec3 l\u00e0m g\u00ec ?<\/strong><\/h3>\n<p><span style=\"font-weight: 400;\">EPAR l\u00e0 b\u1ed9 th\u00f4ng tin \u0111\u00e1nh gi\u00e1 c\u00f4ng khai, gi\u00fap hi\u1ec3u c\u01a1 s\u1edf \u0111\u00e1nh gi\u00e1 v\u00e0 c\u00e1c t\u00e0i li\u1ec7u li\u00ean quan sau khi thu\u1ed1c \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn.<\/span><\/p>\n<h3><strong>Adrreports.eu c\u00f3 ph\u1ea3i l\u00e0 n\u01a1i x\u00e1c nh\u1eadn ch\u1eafc ch\u1eafn thu\u1ed1c g\u00e2y ra t\u00e1c d\u1ee5ng ph\u1ee5 kh\u00f4ng ?<\/strong><\/h3>\n<p><span style=\"font-weight: 400;\">Adrreports.eu hi\u1ec3n th\u1ecb b\u00e1o c\u00e1o ph\u1ea3n \u1ee9ng c\u00f3 h\u1ea1i nghi ng\u1edd; d\u1eef li\u1ec7u n\u00e0y ph\u1ee5c v\u1ee5 gi\u00e1m s\u00e1t v\u00e0 ph\u00e1t hi\u1ec7n t\u00edn hi\u1ec7u, kh\u00f4ng t\u1ef1 \u0111\u1ed9ng ch\u1ee9ng minh quan h\u1ec7 nh\u00e2n qu\u1ea3.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/p>\n<h3><strong>CTIS d\u00f9ng \u0111\u1ec3 l\u00e0m g\u00ec ?<\/strong><\/h3>\n<p><span style=\"font-weight: 400;\">CTIS l\u00e0 n\u1ec1n t\u1ea3ng h\u1ed7 tr\u1ee3 n\u1ed9p, \u0111\u00e1nh gi\u00e1 v\u00e0 gi\u00e1m s\u00e1t th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng t\u1ea1i EU v\u00e0 EEA; c\u00f3 public website \u0111\u1ec3 tra c\u1ee9u th\u00f4ng tin.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">T\u00f4i mu\u1ed1n tra thu\u1ed1c \u0111\u00e3 \u0111\u01b0\u1ee3c EU c\u1ea5p ph\u00e9p theo th\u1ee7 t\u1ee5c t\u1eadp trung th\u00ec b\u1eaft \u0111\u1ea7u \u1edf \u0111\u00e2u ?<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">B\u1eaft \u0111\u1ea7u \u1edf m\u1ee5c Medicines c\u1ee7a EMA v\u00e0 m\u1edf EPAR c\u1ee7a thu\u1ed1c \u0111\u1ec3 xem th\u00f4ng tin s\u1ea3n ph\u1ea9m v\u00e0 t\u00e0i li\u1ec7u c\u00f4ng khai.\u00a0<\/span><\/p>\n<h2><b>K\u1ebft lu\u1eadn<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">EMA l\u00e0 trung t\u00e2m \u0111\u00e1nh gi\u00e1 khoa h\u1ecdc v\u00e0 gi\u00e1m s\u00e1t thu\u1ed1c c\u1ee7a EU, \u0111\u00f3ng vai tr\u00f2 then ch\u1ed1t trong c\u1ea3 tr\u01b0\u1edbc c\u1ea5p ph\u00e9p v\u00e0 sau c\u1ea5p ph\u00e9p. N\u1ebfu b\u1ea1n c\u1ea7n tra thu\u1ed1c, \u0111\u1ecdc c\u01a1 s\u1edf \u0111\u00e1nh gi\u00e1, theo d\u00f5i an to\u00e0n thu\u1ed1c ho\u1eb7c tra c\u1ee9u th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng t\u1ea1i EU, <a href=\"https:\/\/sepro.vn\/\"><strong>Sepro<\/strong> <\/a>khuy\u00ean b\u1ea1n h\u00e3y b\u1eaft \u0111\u1ea7u t\u1eeb Medicines v\u00e0 EPAR, adrreports.eu v\u00e0 CTIS.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>N\u1ebfu b\u1ea1n \u0111ang t\u00ecm m\u1ed9t \u0111\u1ecbnh ngh\u0129a r\u00f5 r\u00e0ng v\u1ec1 EMA, mu\u1ed1n hi\u1ec3u EMA tham gia th\u1ebf n\u00e0o trong quy tr\u00ecnh c\u1ea5p ph\u00e9p thu\u1ed1c t\u1ea1i EU v\u00e0 c\u1ea7n c\u00e1c \u0111\u1ecba ch\u1ec9 tra c\u1ee9u ch\u00ednh th\u1ed1ng nh\u01b0 EPAR ,Adrreports v\u00e0 CTIS, b\u00e0i n\u00e0y s\u1ebd gi\u00fap b\u1ea1n n\u1eafm nhanh trong v\u00e0i ph\u00fat. T\u1ed5 ch\u1ee9c EMA l\u00e0 g\u00ec? &hellip; <a href=\"https:\/\/sepro.vn\/vi\/ema-la-gi-vai-tro-quy-trinh-tra-cuu-thuoc-eu\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">EMA l\u00e0 g\u00ec? Vai tr\u00f2, quy tr\u00ecnh v\u00e0 c\u00e1ch tra c\u1ee9u thu\u1ed1c t\u1ea1i EU<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":9154,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[],"class_list":["post-9145","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"_links":{"self":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9145","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=9145"}],"version-history":[{"count":4,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9145\/revisions"}],"predecessor-version":[{"id":9159,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9145\/revisions\/9159"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9154"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9145"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9145"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9145"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}