{"id":3876,"date":"2024-09-28T16:31:58","date_gmt":"2024-09-28T09:31:58","guid":{"rendered":"https:\/\/ocm-vn.com\/?p=3876"},"modified":"2025-08-15T15:09:40","modified_gmt":"2025-08-15T08:09:40","slug":"gia-cong-my-pham-luat-hien-dai-hoa-quy-dinh-my-pham-cua-fda-mocra-nhung-thay-doi-quan-trong-ban-can-biet","status":"publish","type":"post","link":"https:\/\/ocm-vn.com\/en\/gia-cong-my-pham-luat-hien-dai-hoa-quy-dinh-my-pham-cua-fda-mocra-nhung-thay-doi-quan-trong-ban-can-biet\/","title":{"rendered":"Lu\u1eadt Hi\u1ec7n \u0111\u1ea1i h\u00f3a quy \u0111\u1ecbnh m\u1ef9 ph\u1ea9m c\u1ee7a FDA (MoCRA): Nh\u1eefng thay \u0111\u1ed5i quan tr\u1ecdng b\u1ea1n c\u1ea7n bi\u1ebft"},"content":{"rendered":"<p style=\"text-align: justify\">Lu\u1eadt Hi\u1ec7n \u0110\u1ea1i H\u00f3a Quy \u0110\u1ecbnh M\u1ef9 Ph\u1ea9m (MoCRA) \u0111\u00e3 \u0111\u01b0\u1ee3c C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) th\u00f4ng qua nh\u1eb1m c\u1eadp nh\u1eadt v\u00e0 c\u1ea3i c\u00e1ch quy \u0111\u1ecbnh trong ng\u00e0nh m\u1ef9 ph\u1ea9m. S\u1ef1 ra \u0111\u1eddi c\u1ee7a MoCRA kh\u00f4ng ch\u1ec9 gi\u00fap n\u00e2ng cao an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a s\u1ea3n ph\u1ea9m m\u00e0 c\u00f2n ph\u1ea3n \u00e1nh cam k\u1ebft c\u1ee7a FDA trong vi\u1ec7c b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi ti\u00eau d\u00f9ng. Trong b\u00e0i vi\u1ebft n\u00e0y, ch\u00fang ta s\u1ebd c\u00f9ng t\u00ecm hi\u1ec3u nh\u1eefng \u0111i\u1ec3m n\u1ed5i b\u1eadt c\u1ee7a MoCRA v\u00e0 nh\u1eefng \u0111i\u1ec1u c\u1ea7n bi\u1ebft \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh n\u00e0y.<\/p>\n<h3><strong>B\u1ed1i c\u1ea3nh v\u1ec1 \u0110\u1ea1o lu\u1eadt Hi\u1ec7n \u0110\u1ea1i H\u00f3a Quy \u0110\u1ecbnh M\u1ef9 Ph\u1ea9m n\u0103m 2022 (MoCRA)<\/strong><\/h3>\n<p style=\"text-align: justify\">\u0110\u1ea1o lu\u1eadt Hi\u1ec7n \u0110\u1ea1i H\u00f3a Quy \u0110\u1ecbnh M\u1ef9 Ph\u1ea9m n\u0103m 2022 (MoCRA) \u0111\u00e1nh d\u1ea5u m\u1ed9t s\u1ef1 thay \u0111\u1ed5i quan tr\u1ecdng trong ng\u00e0nh m\u1ef9 ph\u1ea9m, \u0111\u1ea1i di\u1ec7n cho s\u1ef1 m\u1edf r\u1ed9ng l\u1edbn nh\u1ea5t c\u1ee7a quy\u1ec1n h\u1ea1n quy \u0111\u1ecbnh c\u1ee7a FDA k\u1ec3 t\u1eeb \u0110\u1ea1o lu\u1eadt Th\u1ef1c ph\u1ea9m, D\u01b0\u1ee3c ph\u1ea9m v\u00e0 M\u1ef9 ph\u1ea9m Li\u00ean bang (FD&amp;C) n\u0103m 1938. Lu\u1eadt m\u1edbi n\u00e0y \u0111\u01b0a ra c\u00e1c y\u00eau c\u1ea7u to\u00e0n di\u1ec7n nh\u1eb1m n\u00e2ng cao an to\u00e0n, minh b\u1ea1ch v\u00e0 tr\u00e1ch nhi\u1ec7m \u0111\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m tr\u00ean th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3. Tu\u00e2n th\u1ee7 MoCRA hi\u1ec7n l\u00e0 \u0111i\u1ec1u b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi c\u1ea3 th\u01b0\u01a1ng hi\u1ec7u trong n\u01b0\u1edbc v\u00e0 qu\u1ed1c t\u1ebf \u0111\u1ec3 duy tr\u00ec quy\u1ec1n ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng v\u00e0 x\u00e2y d\u1ef1ng ni\u1ec1m tin v\u1edbi ng\u01b0\u1eddi ti\u00eau d\u00f9ng.<\/p>\n<p style=\"text-align: justify\">Khi c\u00e1c quy \u0111\u1ecbnh c\u1ee7a MoCRA c\u00f3 hi\u1ec7u l\u1ef1c, nhu c\u1ea7u tu\u00e2n th\u1ee7 nghi\u00eam ng\u1eb7t tr\u1edf n\u00ean quan tr\u1ecdng h\u01a1n bao gi\u1edd h\u1ebft. C\u00e1c c\u00f4ng ty ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n m\u1edbi n\u00e0y kh\u00f4ng ch\u1ec9 \u0111\u1ec3 tr\u00e1nh h\u00ecnh ph\u1ea1t m\u00e0 c\u00f2n \u0111\u1ec3 duy tr\u00ec t\u00ednh c\u1ea1nh tranh trong m\u1ed9t th\u1ecb tr\u01b0\u1eddng \u0111\u00f4ng \u0111\u00fac. D\u00f9 th\u01b0\u01a1ng hi\u1ec7u c\u1ee7a b\u1ea1n c\u00f3 tr\u1ee5 s\u1edf t\u1ea1i Hoa K\u1ef3 hay ho\u1ea1t \u0111\u1ed9ng qu\u1ed1c t\u1ebf, vi\u1ec7c hi\u1ec3u v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u c\u1ee7a MoCRA l\u00e0 r\u1ea5t quan tr\u1ecdng \u0111\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c th\u00e0nh c\u00f4ng d\u00e0i h\u1ea1n.<\/p>\n<h3><strong>Nh\u1eefng thay \u0111\u1ed5i ch\u00ednh \u0111\u01b0\u1ee3c MoCRA gi\u1edbi thi\u1ec7u:<\/strong><\/h3>\n<p style=\"text-align: justify\">\u2b50\ufe0f<strong>\u0110\u0103ng k\u00fd c\u01a1 s\u1edf:<\/strong> T\u1ea5t c\u1ea3 c\u00e1c c\u01a1 s\u1edf tham gia s\u1ea3n xu\u1ea5t s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m ph\u00e2n ph\u1ed1i t\u1ea1i Hoa K\u1ef3, c\u1ea3 trong n\u01b0\u1edbc v\u00e0 qu\u1ed1c t\u1ebf, \u0111\u1ec1u ph\u1ea3i th\u1ef1c hi\u1ec7n \u0111\u0103ng k\u00fd b\u1eaft bu\u1ed9c. FDA c\u00f3 quy\u1ec1n \u0111\u00ecnh ch\u1ec9 \u0111\u0103ng k\u00fd c\u1ee7a m\u1ed9t c\u01a1 s\u1edf n\u1ebfu h\u1ecd x\u00e1c \u0111\u1ecbnh r\u1eb1ng m\u1ed9t s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m do c\u01a1 s\u1edf \u0111\u00f3 s\u1ea3n xu\u1ea5t v\u00e0 ph\u00e2n ph\u1ed1i t\u1ea1i Hoa K\u1ef3 c\u00f3 kh\u1ea3 n\u0103ng g\u00e2y ra h\u1eadu qu\u1ea3 s\u1ee9c kh\u1ecfe nghi\u00eam tr\u1ecdng ho\u1eb7c th\u1eadm ch\u00ed t\u1eed vong cho con ng\u01b0\u1eddi. \u0110\u1ed3ng th\u1eddi, FDA c\u0169ng ph\u1ea3i c\u00f3 l\u00fd do h\u1ee3p l\u00fd \u0111\u1ec3 tin r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m kh\u00e1c do c\u01a1 s\u1edf n\u00e0y s\u1ea3n xu\u1ea5t c\u0169ng c\u00f3 th\u1ec3 b\u1ecb \u1ea3nh h\u01b0\u1edfng t\u01b0\u01a1ng t\u1ef1. \u0110i\u1ec1u n\u00e0y c\u00f3 th\u1ec3 x\u1ea3y ra trong tr\u01b0\u1eddng h\u1ee3p c\u00f3 s\u1ef1 c\u1ed1 kh\u00f4ng th\u1ec3 c\u00f4 l\u1eadp cho m\u1ed9t s\u1ea3n ph\u1ea9m ho\u1eb7c khi s\u1ef1 c\u1ed1 \u0111\u00f3 \u0111\u1ee7 ph\u1ed5 bi\u1ebfn \u0111\u1ec3 g\u00e2y lo ng\u1ea1i v\u1ec1 c\u00e1c s\u1ea3n ph\u1ea9m kh\u00e1c \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1ea1i c\u01a1 s\u1edf.<\/p>\n<p style=\"text-align: justify\">\u2b50\ufe0f<strong>Danh s\u00e1ch s\u1ea3n ph\u1ea9m:<\/strong> T\u1ea5t c\u1ea3 c\u00e1c s\u1ea3n ph\u1ea9m \u0111ang \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh \u0111\u1ec1u ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd v\u1edbi FDA, bao g\u1ed3m th\u00f4ng tin chi ti\u1ebft v\u1ec1 th\u00e0nh ph\u1ea7n.<\/p>\n<p style=\"text-align: justify\">\u2b50\ufe0f <strong>Th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t (GMP):<\/strong> Th\u1ef1c thi c\u00e1c ti\u00eau chu\u1ea9n GMP th\u1ed1ng nh\u1ea5t t\u1ea1i t\u1ea5t c\u1ea3 c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t m\u1ef9 ph\u1ea9m.<\/p>\n<p style=\"text-align: justify\">\u2b50\ufe0f <strong>Th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t (GMP):<\/strong> Th\u1ef1c thi c\u00e1c ti\u00eau chu\u1ea9n GMP th\u1ed1ng nh\u1ea5t t\u1ea1i t\u1ea5t c\u1ea3 c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t m\u1ef9 ph\u1ea9m.<\/p>\n<p style=\"text-align: justify\">\u2b50\ufe0f<strong>B\u00e1o c\u00e1o s\u1ef1 c\u1ed1 b\u1ea5t l\u1ee3i:<\/strong> C\u00e1c c\u01a1 s\u1edf c\u00f3 tr\u00e1ch nhi\u1ec7m ph\u1ea3i b\u00e1o c\u00e1o b\u1ea5t k\u1ef3 s\u1ef1 c\u1ed1 nghi\u00eam tr\u1ecdng n\u00e0o \u0111\u1ebfn FDA trong kho\u1ea3ng th\u1eddi gian quy \u0111\u1ecbnh. Ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch c\u0169ng c\u1ea7n cung c\u1ea5p th\u00eam th\u00f4ng tin nh\u1ea5t \u0111\u1ecbnh, ch\u1eb3ng h\u1ea1n nh\u01b0 th\u00f4ng tin y t\u1ebf m\u1edbi, nh\u1eadn \u0111\u01b0\u1ee3c trong v\u00f2ng m\u1ed9t n\u0103m k\u1ec3 t\u1eeb khi b\u00e1o c\u00e1o ban \u0111\u1ea7u. FDA c\u0169ng s\u1ebd c\u00f3 quy\u1ec1n truy c\u1eadp v\u00e0o c\u00e1c b\u00e1o c\u00e1o s\u1ef1 c\u1ed1 b\u1ea5t l\u1ee3i trong qu\u00e1 tr\u00ecnh ki\u1ec3m tra.<\/p>\n<p style=\"text-align: justify\">\u2b50\ufe0f <strong>Ch\u1ee9ng minh an to\u00e0n:<\/strong> B\u1eaft bu\u1ed9c ph\u1ea3i cung c\u1ea5p b\u1eb1ng ch\u1ee9ng v\u1ec1 t\u00ednh an to\u00e0n cho m\u1ecdi s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m \u0111\u01b0\u1ee3c ti\u1ebfp th\u1ecb t\u1ea1i Hoa K\u1ef3.<\/p>\n<p style=\"text-align: justify\">\u2b50\ufe0f <strong>Ki\u1ec3m tra h\u1ed3 s\u01a1:<\/strong> MoCRA s\u1eeda \u0111\u1ed5i \u0110\u1ea1o lu\u1eadt FD&amp;C \u0111\u1ec3 quy \u0111\u1ecbnh r\u1eb1ng c\u00e1c cu\u1ed9c ki\u1ec3m tra c\u1ee7a FDA t\u1ea1i c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t m\u1ef9 ph\u1ea9m s\u1ebd bao g\u1ed3m vi\u1ec7c xem x\u00e9t m\u1ed9t s\u1ed1 h\u1ed3 s\u01a1 v\u00e0 th\u00f4ng tin nh\u1ea5t \u0111\u1ecbnh, ch\u1eb3ng h\u1ea1n nh\u01b0 ch\u1ee9ng minh v\u1ec1 an to\u00e0n v\u00e0 th\u00f4ng tin b\u00e1o c\u00e1o s\u1ef1 c\u1ed1 b\u1ea5t l\u1ee3i, khi \u00e1p d\u1ee5ng ti\u00eau chu\u1ea9n ki\u1ec3m tra h\u1ed3 s\u01a1.<\/p>\n<p style=\"text-align: justify\">\u2b50\ufe0f <strong>Quy\u1ec1n m\u1edf l\u1ec7nh thu h\u1ed3i b\u1eaft bu\u1ed9c:<\/strong> N\u1ebfu FDA x\u00e1c \u0111\u1ecbnh r\u1eb1ng c\u00f3 kh\u1ea3 n\u0103ng h\u1ee3p l\u00fd r\u1eb1ng m\u1ed9t s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m b\u1ecb nhi\u1ec5m \u0111\u1ed9c ho\u1eb7c sai nh\u00e3n v\u00e0 vi\u1ec7c s\u1eed d\u1ee5ng ho\u1eb7c ti\u1ebfp x\u00fac v\u1edbi s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m n\u00e0y s\u1ebd g\u00e2y ra h\u1eadu qu\u1ea3 s\u1ee9c kh\u1ecfe nghi\u00eam tr\u1ecdng ho\u1eb7c t\u1eed vong, FDA c\u00f3 quy\u1ec1n ra l\u1ec7nh thu h\u1ed3i b\u1eaft bu\u1ed9c n\u1ebfu ng\u01b0\u1eddi c\u00f3 tr\u00e1ch nhi\u1ec7m t\u1eeb ch\u1ed1i l\u00e0m \u0111i\u1ec1u n\u00e0y theo \u00fd mu\u1ed1n.<\/p>\n<p style=\"text-align: justify\"><strong>\u2b50\ufe0f<\/strong><strong>Nh\u00e3n d\u00e0nh cho s\u1eed d\u1ee5ng chuy\u00ean nghi\u1ec7p<\/strong>: Y\u00eau c\u1ea7u ghi nh\u00e3n c\u1ee5 th\u1ec3 cho c\u00e1c s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m ch\u1ec9 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng b\u1edfi c\u00e1c chuy\u00ean gia c\u00f3 gi\u1ea5y ph\u00e9p. Nh\u00e3n s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m ph\u1ea3i bao g\u1ed3m th\u00f4ng tin li\u00ean h\u1ec7 nh\u1ea5t \u0111\u1ecbnh \u0111\u1ec3 ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch c\u00f3 th\u1ec3 nh\u1eadn b\u00e1o c\u00e1o v\u1ec1 s\u1ef1 c\u1ed1 b\u1ea5t l\u1ee3i. Th\u00f4ng tin li\u00ean h\u1ec7 n\u00e0y ph\u1ea3i bao g\u1ed3m: \u0111\u1ecba ch\u1ec9 trong n\u01b0\u1edbc, s\u1ed1 \u0111i\u1ec7n tho\u1ea1i ho\u1eb7c th\u00f4ng tin li\u00ean l\u1ea1c \u0111i\u1ec7n t\u1eed, c\u00f3 th\u1ec3 bao g\u1ed3m c\u1ea3 trang web.<\/p>\n<p style=\"text-align: justify\">\u2b50\ufe0f <strong>Quy \u0111\u1ecbnh ghi nh\u00e3n c\u00e1c ch\u1ea5t g\u00e2y d\u1ecb \u1ee9ng trong h\u01b0\u01a1ng li\u1ec7u:<\/strong> FDA s\u1ebd ph\u00e1t tri\u1ec3n c\u00e1c quy \u0111\u1ecbnh \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh c\u00e1c ch\u1ea5t g\u00e2y d\u1ecb \u1ee9ng trong h\u01b0\u01a1ng li\u1ec7u c\u1ea7n ph\u1ea3i \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 tr\u00ean nh\u00e3n s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m, \u0111\u1ed3ng th\u1eddi xem x\u00e9t c\u00e1c y\u00eau c\u1ea7u c\u00f4ng b\u1ed1 ch\u1ea5t g\u00e2y d\u1ecb \u1ee9ng t\u1eeb qu\u1ed1c t\u1ebf, ti\u1ec3u bang v\u00e0 \u0111\u1ecba ph\u01b0\u01a1ng.<\/p>\n<p style=\"text-align: justify\">\u2b50\ufe0f <strong>Quy \u0111\u1ecbnh m\u1edbi v\u1ec1 talc v\u00e0 <\/strong>asbestos<strong>:<\/strong> FDA s\u1ebd ph\u00e1t tri\u1ec3n c\u00e1c quy \u0111\u1ecbnh \u0111\u1ec3 thi\u1ebft l\u1eadp v\u00e0 y\u00eau c\u1ea7u c\u00e1c ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra ti\u00eau chu\u1ea9n nh\u1eb1m ph\u00e1t hi\u1ec7n v\u00e0 x\u00e1c \u0111\u1ecbnh s\u1ef1 hi\u1ec7n di\u1ec7n c\u1ee7a talc v\u00e0 asbestos trong c\u00e1c s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m .<\/p>\n<p style=\"text-align: justify\">\u2b50\ufe0f <strong>B\u00e1o c\u00e1o v\u1ec1 PFAS trong m\u1ef9 ph\u1ea9m:<\/strong> FDA s\u1ebd c\u00f4ng b\u1ed1 m\u1ed9t b\u00e1o c\u00e1o t\u00f3m t\u1eaft \u0111\u00e1nh gi\u00e1 an to\u00e0n c\u1ee7a c\u00e1c ch\u1ea5t per- v\u00e0 polyfluoroalkyl (PFAS) trong c\u00e1c s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m.<\/p>\n<h3><strong>Thu\u1eadt ng\u1eef ch\u00ednh:<\/strong><\/h3>\n<p style=\"text-align: justify\"><strong>\u2728S\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m:<\/strong> L\u00e0 ch\u1ebf ph\u1ea9m g\u1ed3m c\u00e1c th\u00e0nh ph\u1ea7n m\u1ef9 ph\u1ea9m c\u00f3 th\u00e0nh ph\u1ea7n \u0111\u1ecbnh t\u00ednh v\u00e0 \u0111\u1ecbnh l\u01b0\u1ee3ng nh\u1ea5t \u0111\u1ecbnh \u0111\u1ec3 s\u1eed d\u1ee5ng trong s\u1ea3n ph\u1ea9m ho\u00e0n thi\u1ec7n.<\/p>\n<p style=\"text-align: justify\"><strong>\u2728C\u01a1 s\u1edf:<\/strong> L\u00e0 b\u1ea5t k\u1ef3 c\u01a1 s\u1edf n\u00e0o (bao g\u1ed3m c\u1ea3 c\u01a1 s\u1edf c\u1ee7a nh\u00e0 nh\u1eadp kh\u1ea9u) s\u1ea3n xu\u1ea5t ho\u1eb7c ch\u1ebf bi\u1ebfn s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m ph\u00e2n ph\u1ed1i t\u1ea1i Hoa K\u1ef3.<\/p>\n<p style=\"text-align: justify\"><strong>\u2728C\u00e1c tr\u01b0\u1eddng h\u1ee3p lo\u1ea1i tr\u1eeb:<\/strong> Bao g\u1ed3m m\u1ed9t s\u1ed1 ti\u1ec7m l\u00e0m \u0111\u1eb9p v\u00e0 salon, m\u1ed9t s\u1ed1 nh\u00e0 b\u00e1n l\u1ebb, b\u1ec7nh vi\u1ec7n, c\u01a1 quan y t\u1ebf c\u00f4ng c\u1ed9ng, h\u1ed9i ch\u1ee3 th\u01b0\u01a1ng m\u1ea1i, m\u1ed9t s\u1ed1 c\u01a1 s\u1edf nghi\u00ean c\u1ee9u v\u00e0 th\u1eed nghi\u1ec7m, v\u00e0 c\u00e1c c\u01a1 s\u1edf ch\u1ec9 th\u1ef1c hi\u1ec7n m\u1ed9t ho\u1eb7c m\u1ed9t s\u1ed1 c\u00f4ng vi\u1ec7c sau \u0111\u00e2y li\u00ean quan \u0111\u1ebfn s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m: ghi nh\u00e3n, thay nh\u00e3n, \u0111\u00f3ng g\u00f3i, \u0111\u00f3ng g\u00f3i l\u1ea1i, l\u01b0u gi\u1eef v\u00e0 ph\u00e2n ph\u1ed1i.<\/p>\n<p style=\"text-align: justify\"><strong>\u2728Ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch:<\/strong> L\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t, \u0111\u00f3ng g\u00f3i ho\u1eb7c ph\u00e2n ph\u1ed1i s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m, t\u00ean c\u1ee7a ng\u01b0\u1eddi n\u00e0y xu\u1ea5t hi\u1ec7n tr\u00ean nh\u00e3n c\u1ee7a s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m.<\/p>\n<p style=\"text-align: justify\"><strong>\u2728S\u1ef1 c\u1ed1 b\u1ea5t l\u1ee3i:<\/strong> L\u00e0 b\u1ea5t k\u1ef3 s\u1ef1 ki\u1ec7n li\u00ean quan \u0111\u1ebfn s\u1ee9c kh\u1ecfe n\u00e0o li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m m\u00e0 c\u00f3 t\u00ednh ch\u1ea5t ti\u00eau c\u1ef1c.<\/p>\n<p style=\"text-align: justify\"><strong>\u2728S\u1ef1 c\u1ed1 b\u1ea5t l\u1ee3i nghi\u00eam tr\u1ecdng:<\/strong> L\u00e0 s\u1ef1 c\u1ed1 b\u1ea5t l\u1ee3i c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn:<\/p>\n<ul style=\"text-align: justify\">\n<li><em>T\u1eed vong;<\/em><\/li>\n<li><em>Tr\u1ea3i nghi\u1ec7m \u0111e d\u1ecda \u0111\u1ebfn t\u00ednh m\u1ea1ng;<\/em><\/li>\n<li><em>Nh\u1eadp vi\u1ec7n \u0111i\u1ec1u tr\u1ecb;<\/em><\/li>\n<li><em>M\u1ed9t khuy\u1ebft t\u1eadt ho\u1eb7c s\u1ef1 t\u00e0n t\u1eadt \u0111\u00e1ng k\u1ec3 ho\u1eb7c k\u00e9o d\u00e0i;<\/em><\/li>\n<li><em>D\u1ecb t\u1eadt b\u1ea9m sinh ho\u1eb7c khuy\u1ebft t\u1eadt sinh ra;<\/em><\/li>\n<li><em>Nhi\u1ec5m tr\u00f9ng; ho\u1eb7c<\/em><\/li>\n<li><em>Bi\u1ebfn d\u1ea1ng \u0111\u00e1ng k\u1ec3 (bao g\u1ed3m c\u00e1c tri\u1ec7u ch\u1ee9ng nh\u01b0 ph\u00e1t ban nghi\u00eam tr\u1ecdng v\u00e0 k\u00e9o d\u00e0i, b\u1ecfng \u0111\u1ed9 hai ho\u1eb7c ba, m\u1ea5t t\u00f3c \u0111\u00e1ng k\u1ec3, ho\u1eb7c s\u1ef1 thay \u0111\u1ed5i h\u00ecnh d\u00e1ng k\u00e9o d\u00e0i ho\u1eb7c \u0111\u00e1ng k\u1ec3), kh\u00f4ng ph\u1ea3i theo \u00fd \u0111\u1ecbnh trong c\u00e1c \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng th\u00f4ng th\u01b0\u1eddng; ho\u1eb7c<\/em><\/li>\n<\/ul>\n<p style=\"text-align: justify\"><em>(B) Y\u00eau c\u1ea7u, d\u1ef1a tr\u00ean ph\u00e1n \u0111o\u00e1n y t\u1ebf h\u1ee3p l\u00fd, can thi\u1ec7p y t\u1ebf ho\u1eb7c ph\u1eabu thu\u1eadt \u0111\u1ec3 ng\u0103n ch\u1eb7n m\u1ed9t k\u1ebft qu\u1ea3 nh\u01b0 \u0111\u00e3 n\u00eau \u1edf (A) tr\u00ean.<\/em><\/p>\n<h6 style=\"text-align: justify\"><em>Source:<a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/<\/a><\/em><\/h6>\n<h3 style=\"text-align: justify\"><strong>Conclusion<\/strong><\/h3>\n<p style=\"text-align: justify\">Nh\u1eefng thay \u0111\u1ed5i trong quy \u0111\u1ecbnh n\u00e0y kh\u00f4ng ch\u1ec9 \u0111\u1eb7t ra th\u00e1ch th\u1ee9c m\u00e0 c\u00f2n m\u1edf ra c\u01a1 h\u1ed9i cho c\u00e1c th\u01b0\u01a1ng hi\u1ec7u m\u1ef9 ph\u1ea9m, \u0111\u1eb7c bi\u1ec7t l\u00e0 nh\u1eefng th\u01b0\u01a1ng hi\u1ec7u b\u00ean ngo\u00e0i Hoa K\u1ef3 mu\u1ed1n gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng n\u00e0y. T\u1ea1i OCM Vi\u1ec7t Nam, ch\u00fang t\u00f4i t\u1ef1 h\u00e0o l\u00e0 \u0111\u1ed1i t\u00e1c tin c\u1eady, gi\u00fap kh\u00e1ch h\u00e0ng v\u01b0\u1ee3t qua nh\u1eefng thay \u0111\u1ed5i quy \u0111\u1ecbnh m\u1ed9t c\u00e1ch t\u1ef1 tin.<\/p>\n<p style=\"text-align: justify\">L\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t OEM\/ODM m\u1ef9 ph\u1ea9m chuy\u00ean nghi\u1ec7p, OCM Vi\u1ec7t Nam cung c\u1ea5p c\u00e1c d\u1ecbch v\u1ee5 to\u00e0n di\u1ec7n, t\u1eeb ph\u00e1t tri\u1ec3n s\u1ea3n ph\u1ea9m, c\u00f4ng th\u1ee9c, th\u1eed nghi\u1ec7m, \u0111\u1ebfn \u0111\u00f3ng g\u00f3i, ghi nh\u00e3n v\u00e0 \u0111\u1ea3m b\u1ea3o tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh. \u0110\u1ed9i ng\u0169 chuy\u00ean gia c\u1ee7a ch\u00fang t\u00f4i lu\u00f4n s\u1eb5n s\u00e0ng h\u1ed7 tr\u1ee3 b\u1ea1n \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u c\u1ee7a th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3, \u0111\u1ed3ng th\u1eddi cam k\u1ebft mang \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng d\u1ecbch v\u1ee5 v\u00e0 gi\u00e1 tr\u1ecb t\u1ed1t nh\u1ea5t.<\/p>\n<p style=\"text-align: justify\">N\u1ebfu b\u1ea1n \u0111ang t\u00ecm ki\u1ebfm m\u1ed9t \u0111\u1ed1i t\u00e1c gia c\u00f4ng m\u1ef9 ph\u1ea9m \u0111\u00e1ng tin c\u1eady \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh v\u00e0 \u0111\u1ed5i m\u1edbi s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m, h\u00e3y li\u00ean h\u1ec7 v\u1edbi OCM ngay h\u00f4m nay. Ch\u00fang t\u00f4i r\u1ea5t mong \u0111\u01b0\u1ee3c th\u1ea3o lu\u1eadn v\u1ec1 c\u00e1ch th\u1ee9c gi\u00fap b\u1ea1n \u0111\u1ea1t \u0111\u01b0\u1ee3c nh\u1eefng m\u1ee5c ti\u00eau c\u1ee7a m\u00ecnh.<\/p>","protected":false},"excerpt":{"rendered":"<p>Lu\u1eadt Hi\u1ec7n \u0110\u1ea1i H\u00f3a Quy \u0110\u1ecbnh M\u1ef9 Ph\u1ea9m (MoCRA) \u0111\u00e3 \u0111\u01b0\u1ee3c C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) th\u00f4ng qua nh\u1eb1m c\u1eadp nh\u1eadt v\u00e0 c\u1ea3i c\u00e1ch quy \u0111\u1ecbnh trong ng\u00e0nh m\u1ef9 ph\u1ea9m. S\u1ef1 ra \u0111\u1eddi c\u1ee7a MoCRA kh\u00f4ng ch\u1ec9 gi\u00fap n\u00e2ng cao an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a s\u1ea3n ph\u1ea9m m\u00e0 [&hellip;]<\/p>","protected":false},"author":3,"featured_media":3874,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[70,69],"tags":[],"_links":{"self":[{"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/posts\/3876"}],"collection":[{"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/comments?post=3876"}],"version-history":[{"count":10,"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/posts\/3876\/revisions"}],"predecessor-version":[{"id":3888,"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/posts\/3876\/revisions\/3888"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/media\/3874"}],"wp:attachment":[{"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/media?parent=3876"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/categories?post=3876"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ocm-vn.com\/en\/wp-json\/wp\/v2\/tags?post=3876"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}