{"id":9270,"date":"2026-03-03T20:42:22","date_gmt":"2026-03-03T20:42:22","guid":{"rendered":"https:\/\/sepro.vn\/?p=9270"},"modified":"2026-03-03T20:42:22","modified_gmt":"2026-03-03T20:42:22","slug":"fda-la-gi-vai-tro-va-quy-dinh-trong-nganh-duoc","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/fda-la-gi-vai-tro-va-quy-dinh-trong-nganh-duoc\/","title":{"rendered":"FDA l\u00e0 g\u00ec? To\u00e0n t\u1eadp v\u1ec1 vai tr\u00f2 v\u00e0 quy \u0111\u1ecbnh trong ng\u00e0nh D\u01b0\u1ee3c"},"content":{"rendered":"

Trong v\u1eadn h\u00e0nh nh\u00e0 m\u00e1y v\u00e0 ho\u1ea1t \u0111\u1ed9ng xu\u1ea5t kh\u1ea9u, c\u00e1c thu\u1eadt ng\u1eef nh\u01b0 <\/span>\u201cFDA Certificate\u201d<\/b>, <\/span>\u201cFDA Registered\u201d<\/b> v\u00e0 <\/span>\u201cFDA Approved\u201d<\/b> th\u01b0\u1eddng xuy\u00ean \u0111\u01b0\u1ee3c \u0111\u1ec1 c\u1eadp. Tuy nhi\u00ean, ba kh\u00e1i ni\u1ec7m n\u00e0y kh\u00f4ng \u0111\u1ed3ng ngh\u0129a v\u1ec1 m\u1eb7t ph\u00e1p l\u00fd. Vi\u1ec7c s\u1eed d\u1ee5ng kh\u00f4ng ch\u00ednh x\u00e1c c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn sai l\u1ec7ch th\u00f4ng tin trong h\u1ed3 s\u01a1, t\u00e0i li\u1ec7u th\u01b0\u01a1ng m\u1ea1i ho\u1eb7c qu\u00e1 tr\u00ecnh gi\u1ea3i tr\u00ecnh v\u1edbi c\u01a1 quan ch\u1ee9c n\u0103ng.<\/span><\/p>\n

B\u00e0i vi\u1ebft n\u00e0y t\u1eadp trung l\u00e0m r\u00f5 b\u1ea3n ch\u1ea5t ph\u00e1p l\u00fd v\u00e0 ph\u1ea1m vi \u00e1p d\u1ee5ng c\u1ee7a t\u1eebng thu\u1eadt ng\u1eef theo quy \u0111\u1ecbnh c\u1ee7a FDA. M\u1ee5c ti\u00eau l\u00e0 cung c\u1ea5p c\u00e1ch hi\u1ec3u v\u00e0 c\u00e1ch di\u1ec5n \u0111\u1ea1t chu\u1ea9n x\u00e1c trong b\u1ed1i c\u1ea3nh s\u1ea3n xu\u1ea5t, xu\u1ea5t kh\u1ea9u v\u00e0 qu\u1ea3n l\u00fd tu\u00e2n th\u1ee7, nh\u1eb1m h\u1ea1n ch\u1ebf r\u1ee7i ro v\u00e0 \u0111\u1ea3m b\u1ea3o t\u00ednh minh b\u1ea1ch trong ho\u1ea1t \u0111\u1ed9ng doanh nghi\u1ec7p.<\/span><\/p>\n

FDA l\u00e0 g\u00ec?<\/b><\/h2>\n
\"what-is-fda\"
FDA l\u00e0 g\u00ec<\/em><\/figcaption><\/figure>\n

FDA l\u00e0 c\u01a1 quan g\u00ec v\u00e0 s\u1ee9 m\u1ec7nh c\u1ed1t l\u00f5i li\u00ean quan \u0111\u1ebfn thu\u1ed1c<\/b><\/h3>\n

FDA l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3, t\u00ean ti\u1ebfng Anh l\u00e0 Food and Drug Administration<\/strong><\/a>. \u0110\u00e2y l\u00e0 c\u01a1 quan qu\u1ea3n l\u00fd c\u1ee7a Hoa K\u1ef3 v\u1edbi s\u1ee9 m\u1ec7nh b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng, trong \u0111\u00f3 c\u00f3 nhi\u1ec7m v\u1ee5 b\u1ea3o \u0111\u1ea3m thu\u1ed1c d\u00f9ng cho ng\u01b0\u1eddi v\u00e0 th\u00fa y \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u v\u1ec1 an to\u00e0n, hi\u1ec7u qu\u1ea3 \u0111\u1ed1i v\u1edbi chu\u1ed7i cung \u1ee9ng.<\/span><\/p>\n

FDA kh\u00f4ng ho\u1ea1t \u0111\u1ed9ng nh\u01b0 m\u1ed9t \u0111\u01a1n v\u1ecb c\u1ea5p ch\u1ee9ng ch\u1ec9 ch\u1ea5t l\u01b0\u1ee3ng n\u1ed9p h\u1ed3 s\u01a1 l\u00e0 xong. H\u1ecd lu\u00f4n s\u1ebd \u0111\u1eb7t ra c\u00e1c y\u00eau c\u1ea7u, xem x\u00e9t k\u1ef9 b\u1eb1ng ch\u1ee9ng v\u00e0 ki\u1ec3m tra \u0111\u1ecbnh k\u1ef3 vi\u1ec7c tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh t\u1ea1i c\u00e1c c\u01a1 s\u1edf nh\u00e0 m\u00e1y.<\/span><\/p>\n

FDA qu\u1ea3n l\u00fd thu\u1ed1c qua nh\u1eefng trung t\u00e2m n\u00e0o<\/b><\/h3>\n

Vi\u1ec7c qu\u1ea3n l\u00fd thu\u1ed1c \u0111\u01b0\u1ee3c m\u1ed9t \u0111\u01a1n v\u1ecb quan tr\u1ecdng c\u1ee7a FDA l\u00e0 Trung t\u00e2m \u0110\u00e1nh gi\u00e1 v\u00e0 Nghi\u00ean c\u1ee9u Thu\u1ed1c, t\u00ean ti\u1ebfng Anh l\u00e0 <\/span>Center for Drug Evaluation and Research<\/b><\/a>, vi\u1ebft t\u1eaft CDER. H\u1ecd c\u0103n c\u1ee9 v\u00e0o khoa h\u1ecdc v\u00e0 c\u00e1c d\u1eef li\u1ec7u \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh \u0111\u1ec3 b\u1ea3o \u0111\u1ea3m thu\u1ed1c c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng, an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3.<\/span><\/p>\n

FDA qu\u1ea3n l\u00fd d\u01b0\u1ee3c ph\u1ea9m theo 3 l\u1edbp c\u00f4ng vi\u1ec7c<\/b><\/h2>\n
\"fda-quan-ly-duoc-pham-theo-3-lop\"
FDA qu\u1ea3n l\u00fd d\u01b0\u1ee3c ph\u1ea9m theo 3 l\u1edbp<\/em><\/figcaption><\/figure>\n

Tr\u01b0\u1edbc khi thu\u1ed1c \u0111\u01b0\u1ee3c b\u00e1n t\u1ea1i M\u1ef9<\/b><\/h3>\n

L\u1edbp th\u1ee9 nh\u1ea5t l\u00e0 giai \u0111o\u1ea1n tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00e9p \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng. \u1ede giai \u0111o\u1ea1n n\u00e0y, y\u1ebfu t\u1ed1 h\u00e0ng \u0111\u1ea7u l\u00e0 vi\u1ec7c ch\u1ee9ng minh thu\u1ed1c th\u1eadt s\u1ef1 c\u00f3 hi\u1ec7u qu\u1ea3, th\u1eadt s\u1ef1 an to\u00e0n v\u00e0 c\u00e1ch s\u1ea3n xu\u1ea5t, ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ea1t y\u00eau c\u1ea7u \u0111\u1ec3 t\u1ea1o ra s\u1ea3n ph\u1ea9m an to\u00e0n cho ng\u01b0\u1eddi d\u00f9ng.<\/span><\/p>\n

\u0110\u1ec3 qua \u0111\u01b0\u1ee3c l\u1edbp c\u00f4ng vi\u1ec7c \u0111\u1ea7u, FDA c\u1ea7n b\u1ea1n ph\u1ea3i cho th\u1ea5y \u0111\u01b0\u1ee3c m\u1ed9t b\u1ee9c tranh t\u1ed5ng qu\u00e1t c\u1ee7a thu\u1ed1c, t\u1eeb d\u1eef li\u1ec7u nghi\u00ean c\u1ee9u \u0111\u1ebfn nh\u00e3n v\u00e0 kh\u1ea3 n\u0103ng s\u1ea3n xu\u1ea5t.\u00a0<\/span><\/p>\n

FDA c\u00f4ng b\u1ed1 r\u00f5 r\u00e0ng khi \u0111\u0103ng k\u00fd h\u1ed3 s\u01a1 l\u01b0u h\u00e0nh thu\u1ed1c m\u1edbi. B\u1ea1n c\u1ea7n l\u00e0m r\u00f5 3 \u0111i\u1ec1u: an to\u00e0n, hi\u1ec7u qu\u1ea3 v\u00e0 \u0111\u1ea7y \u0111\u1ee7 ch\u1ee9ng nh\u1eadn ch\u01b0a? M\u1ebb thu\u1ed1c c\u00f3 th\u1eadt s\u1ef1 \u0111\u00e3 \u0111\u1ee7 \u1ed5n \u0111\u1ecbnh, \u0111\u1ee7 tinh khi\u1ebft, \u0111\u1ee7 ch\u1ea5t l\u01b0\u1ee3ng cho ng\u01b0\u1eddi d\u00f9ng ch\u01b0a ?<\/span><\/p>\n

Trong s\u1ea3n xu\u1ea5t v\u00e0 h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng<\/b><\/h3>\n

L\u1edbp th\u1ee9 hai l\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng. Nhi\u1ec1u nh\u00e0 m\u00e1y g\u1ecdi chung l\u00e0 tu\u00e2n th\u1ee7 FDA. Tuy nhi\u00ean trong v\u1eadn h\u00e0nh, tr\u1ecdng t\u00e2m th\u01b0\u1eddng n\u1eb1m \u1edf th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t, t\u00ean ti\u1ebfng Anh l\u00e0 current good manufacturing practice, vi\u1ebft t\u1eaft <\/span>cGMP<\/b><\/a>.<\/span><\/p>\n

FDA m\u00f4 t\u1ea3 cGMP l\u00e0 c\u00e1c y\u00eau c\u1ea7u t\u1ed1i thi\u1ec3u v\u1ec1 ph\u01b0\u01a1ng ph\u00e1p, c\u01a1 s\u1edf v\u1eadt ch\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t trong s\u1ea3n xu\u1ea5t, ch\u1ebf bi\u1ebfn v\u00e0 \u0111\u00f3ng g\u00f3i thu\u1ed1c. M\u1ee5c ti\u00eau l\u00e0 b\u1ea3o \u0111\u1ea3m s\u1ea3n ph\u1ea9m an to\u00e0n khi s\u1eed d\u1ee5ng v\u00e0 c\u00f3 th\u00e0nh ph\u1ea7n, h\u00e0m l\u01b0\u1ee3ng \u0111\u00fang nh\u01b0 \u0111\u00e3 c\u00f4ng b\u1ed1.\u00a0<\/span><\/p>\n

Sau khi thu\u1ed1c l\u01b0u h\u00e0nh<\/b><\/h3>\n

L\u1edbp th\u1ee9 ba l\u00e0 sau khi thu\u1ed1c \u0111\u01b0\u1ee3c nh\u1eadp v\u00e0o th\u1ecb tr\u01b0\u1eddng. Qu\u1ea3n tr\u1ecb r\u1ee7i ro kh\u00f4ng d\u1eebng l\u1ea1i \u1edf th\u1eddi \u0111i\u1ec3m \u0111\u01b0\u1ee3c ph\u00e9p l\u01b0u h\u00e0nh. Vi\u1ec7c quan tr\u1ecdng c\u1ea7n th\u1ef1c hi\u1ec7n l\u00fac n\u00e0y l\u00e0 theo d\u00f5i an to\u00e0n, x\u1eed l\u00fd c\u1ea3nh b\u00e1o v\u00e0 qu\u1ea3n l\u00fd v\u00f2ng \u0111\u1eddi s\u1ea3n ph\u1ea9m. Quan s\u00e1t d\u1eef li\u1ec7u th\u1ef1c t\u1ebf \u0111\u1ec3 \u0111i\u1ec1u ch\u1ec9nh v\u00e0 c\u1ea3i ti\u1ebfn s\u1ea3n ph\u1ea9m.\u00a0<\/span><\/p>\n

C\u00e1c thu\u1eadt ng\u1eef d\u1ec5 g\u00e2y hi\u1ec3u sai trong ng\u00e0nh d\u01b0\u1ee3c<\/b><\/h2>\n
\"cac-thuat-ngu-de-gay-hieu-sai-trong-nganh-duoc\"
C\u00e1c thu\u1eadt ng\u1eef d\u1ec5 g\u00e2y hi\u1ec3u sai trong ng\u00e0nh D\u01b0\u1ee3c<\/em><\/figcaption><\/figure>\n

FDA approval l\u00e0 g\u00ec v\u00e0 \u00e1p d\u1ee5ng cho \u0111\u1ed1i t\u01b0\u1ee3ng n\u00e0o<\/b><\/h3>\n

FDA approval th\u01b0\u1eddng l\u00e0 vi\u1ec7c FDA ph\u00ea duy\u1ec7t m\u1ed9t h\u1ed3 s\u01a1 c\u1ee5 th\u1ec3 cho m\u1ed9t s\u1ea3n ph\u1ea9m c\u1ee5 th\u1ec3 trong m\u1ed9t ph\u1ea1m vi ch\u1ec9 \u0111\u1ecbnh c\u1ee5 th\u1ec3. \u0110\u00e2y l\u00e0 k\u1ebft lu\u1eadn d\u1ef1a tr\u00ean d\u1eef li\u1ec7u th\u1ef1c t\u1ebf, kh\u00f4ng ph\u1ea3i ti\u00eau chu\u1ea9n chung \u0111\u1ec3 \u00e1p d\u1ee5ng cho m\u1ecdi s\u1ea3n ph\u1ea9m, m\u1ecdi nh\u00e0 m\u00e1y.<\/span><\/p>\n

\u0110i\u1ec3m d\u1ec5 sai l\u00e0 d\u00f9ng approval nh\u01b0 m\u1ed9t t\u1eeb thay cho ch\u1ea5t l\u01b0\u1ee3ng. Trong nh\u00e0 m\u00e1y, ch\u1ea5t l\u01b0\u1ee3ng n\u1eb1m \u1edf vi\u1ec7c ch\u1ee9ng minh \u0111\u01b0\u1ee3c t\u00ednh hi\u1ec7u qu\u1ea3 v\u00e0 \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n khi v\u1eadn h\u00e0nh v\u00e0 s\u1ea3n xu\u1ea5t. Approval l\u00e0 quy\u1ebft \u0111\u1ecbnh d\u00e0nh cho m\u1ed9t h\u1ed3 s\u01a1 v\u00e0 m\u1ed9t ph\u1ea1m vi.<\/span><\/p>\n

FDA registration l\u00e0 g\u00ec trong d\u01b0\u1ee3c<\/b><\/h3>\n

Registration trong d\u01b0\u1ee3c th\u01b0\u1eddng li\u00ean quan \u0111\u1ebfn \u0111\u0103ng k\u00fd c\u01a1 s\u1edf v\u00e0 ngh\u0129a v\u1ee5 khai b\u00e1o theo quy \u0111\u1ecbnh. M\u1ee5c ti\u00eau l\u00e0 gi\u00fap c\u01a1 quan qu\u1ea3n l\u00fd bi\u1ebft c\u01a1 s\u1edf n\u00e0o tham gia s\u1ea3n xu\u1ea5t ho\u1eb7c c\u00e1c ho\u1ea1t \u0111\u1ed9ng li\u00ean quan, t\u1eeb \u0111\u00f3 l\u00e0m b\u01b0\u1edbc n\u1ec1n cho c\u00f4ng t\u00e1c th\u1ea9m \u0111\u1ecbnh. Quy \u0111\u1ecbnh v\u1ec1 \u0111\u0103ng k\u00fd c\u01a1 s\u1edf v\u00e0 khai b\u00e1o danh m\u1ee5c thu\u1ed1c n\u1eb1m trong Title 21 c\u1ee7a B\u1ed9 Quy \u0111\u1ecbnh Li\u00ean bang Hoa K\u1ef3, th\u01b0\u1eddng g\u1ecdi t\u1eaft l\u00e0 21 CFR.<\/span><\/p>\n

Drug listing v\u00e0 NDC l\u00e0 g\u00ec<\/b><\/h3>\n

Drug listing l\u00e0 khai b\u00e1o danh m\u1ee5c s\u1ea3n ph\u1ea9m thu\u1ed1c theo y\u00eau c\u1ea7u. NDC l\u00e0 m\u00e3 \u0111\u1ecbnh danh qu\u1ed1c gia cho thu\u1ed1c, vi\u1ebft \u0111\u1ea7y \u0111\u1ee7 l\u00e0 National Drug Code, th\u01b0\u1eddng g\u1ecdi t\u1eaft NDC. Ng\u01b0\u1eddi m\u1edbi hay hi\u1ec3u nh\u1ea7m r\u1eb1ng c\u00f3 NDC l\u00e0 \u0111\u00e3 \u0111\u01b0\u1ee3c FDA ph\u00ea duy\u1ec7t.<\/span><\/p>\n

FDA n\u00eau r\u00f5 tr\u00ean trang <\/span>NDC Directory<\/b><\/a> r\u1eb1ng vi\u1ec7c c\u00f3 m\u1eb7t trong danh m\u1ee5c NDC kh\u00f4ng c\u00f3 ngh\u0129a FDA \u0111\u00e3 ki\u1ec3m ch\u1ee9ng th\u00f4ng tin hay s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c FDA ph\u00ea duy\u1ec7t. Th\u1eadm ch\u00ed, m\u1ecdi c\u00f4ng b\u1ed1 tr\u01b0\u1edbc khi c\u00f3 s\u1ef1 x\u00e1c nh\u1eadn c\u1ee7a FDA v\u1ec1 vi\u1ec7c ki\u1ec3m ch\u1ee9ng th\u00f4ng tin, s\u1ea3n ph\u1ea9m l\u00e0 vi ph\u1ea1m lu\u1eadt li\u00ean bang.<\/span><\/p>\n

V\u00ec sao \u0111\u0103ng k\u00fd c\u01a1 s\u1edf ho\u1eb7c c\u00f3 NDC kh\u00f4ng c\u00f3 ngh\u0129a FDA ph\u00ea duy\u1ec7t<\/b><\/h3>\n

B\u1ea1n h\u00e3y hi\u1ec3u m\u1ed9t c\u00e1ch \u0111\u01a1n gi\u1ea3n vi\u1ec7c \u0111\u0103ng k\u00fd v\u00e0 m\u00e3 \u0111\u1ecbnh danh ch\u1ec9 l\u00e0 ph\u1ea7n khai b\u00e1o \u0111\u1ec3 c\u01a1 quan qu\u1ea3n l\u00fd bi\u1ebft c\u01a1 s\u1edf v\u00e0 s\u1ea3n ph\u1ea9m n\u00e0o \u0111ang tham gia th\u1ecb tr\u01b0\u1eddng. Ph\u00ea duy\u1ec7t l\u00e0 quy\u1ebft \u0111\u1ecbnh ri\u00eang cho t\u1eebng h\u1ed3 s\u01a1 s\u1ea3n ph\u1ea9m, d\u1ef1a tr\u00ean vi\u1ec7c xem x\u00e9t c\u00e1c h\u1ed3 s\u01a1 x\u00e1c minh \u0111\u1ebfn t\u1eeb nh\u00e0 m\u00e1y.<\/span><\/p>\n

V\u00ec v\u1eady, khi b\u1ea1n th\u1ea5y qu\u1ea3ng b\u00e1 ki\u1ec3u FDA registered, h\u00e3y h\u1ecfi r\u00f5 h\u1ecd \u0111\u0103ng k\u00fd n\u1ed9i dung g\u00ec. \u0110\u0103ng k\u00fd c\u01a1 s\u1edf hay khai b\u00e1o danh m\u1ee5c s\u1ea3n ph\u1ea9m. Sau \u0111\u00f3 ki\u1ec3m tra xem th\u00f4ng tin \u0111\u00f3 c\u00f3 n\u00f3i g\u00ec v\u1ec1 vi\u1ec7c s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t hay kh\u00f4ng \u0111\u1ec3 tr\u00e1nh nh\u1eefng nh\u1ea7m l\u1eabn kh\u00f4ng \u0111\u00e1ng c\u00f3.<\/span><\/p>\n

Quy tr\u00ecnh qu\u1ea3n l\u00fd thu\u1ed1c c\u1ee7a FDA \u1edf b\u01b0\u1edbc \u0111\u1ea7u nh\u01b0ng \u0111\u00fang b\u1ea3n ch\u1ea5t<\/b><\/h2>\n
\"quy-trinh-quan-ly-thuoc-cua-fda-o-buoc-dau\"
Quy tr\u00ecnh qu\u1ea3n l\u00fd thu\u1ed1c c\u1ee7a FDA \u1edf b\u01b0\u1edbc \u0111\u1ea7u<\/em><\/figcaption><\/figure>\n

Giai \u0111o\u1ea1n nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng v\u00e0 chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1<\/b><\/h3>\n

Gia \u0111o\u1ea1n \u0111\u1ea7u, b\u1ea1n ch\u1ec9 c\u1ea7n n\u1eafm v\u1eefng c\u00e1c nguy\u00ean t\u1eafc. Giai \u0111o\u1ea1n ti\u1ec1n l\u00e2m s\u00e0ng t\u1eadp trung v\u00e0o d\u1eef li\u1ec7u h\u1ed7 tr\u1ee3 m\u1ee9c an to\u00e0n h\u1ee3p l\u00fd cho b\u01b0\u1edbc th\u1eed nghi\u1ec7m tr\u00ean ng\u01b0\u1eddi v\u00e0 c\u01a1 s\u1edf khoa h\u1ecdc \u0111\u1ec3 ti\u1ebfp t\u1ee5c ph\u00e1t tri\u1ec3n.<\/span><\/p>\n

IND v\u00e0 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng<\/b><\/h3>\n

IND l\u00e0 h\u1ed3 s\u01a1 xin ph\u00e9p thu\u1ed1c th\u1eed nghi\u1ec7m, vi\u1ebft \u0111\u1ea7y \u0111\u1ee7 l\u00e0 Investigational New Drug. FDA m\u00f4 t\u1ea3 IND l\u00e0 ph\u01b0\u01a1ng ti\u1ec7n \u0111\u1ec3 nh\u00e0 t\u00e0i tr\u1ee3 xin mi\u1ec5n tr\u1eeb y\u00eau c\u1ea7u ph\u1ea3i c\u00f3 h\u1ed3 s\u01a1 l\u01b0u h\u00e0nh tr\u01b0\u1edbc khi v\u1eadn chuy\u1ec3n v\u00e0 ph\u00e2n ph\u1ed1i thu\u1ed1c qua c\u00e1c bang nh\u1eb1m ph\u1ee5c v\u1ee5 th\u1eed nghi\u1ec7m.<\/span><\/p>\n

\u0110i\u1ec3m v\u1eadn h\u00e0nh c\u1ea7n hi\u1ec3u l\u00e0 IND kh\u00f4ng ph\u1ea3i ph\u00ea duy\u1ec7t b\u00e1n thu\u1ed1c. IND l\u00e0 c\u01a1 ch\u1ebf cho ph\u00e9p b\u01b0\u1edbc v\u00e0o th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng trong khu\u00f4n kh\u1ed5 qu\u1ea3n l\u00fd r\u1ee7i ro nghi\u00ean c\u1ee9u.<\/span><\/p>\n

NDA l\u00e0 g\u00ec v\u00e0 FDA \u0111\u00e1nh gi\u00e1 nh\u1eefng g\u00ec<\/b><\/h3>\n

NDA <\/b><\/a>l\u00e0 h\u1ed3 s\u01a1 xin ph\u00e9p \u0111\u01b0a m\u1ed9t thu\u1ed1c m\u1edbi ra th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3, t\u00ean \u0111\u1ea7y \u0111\u1ee7 l\u00e0 New Drug Application. FDA d\u00f9ng h\u1ed3 s\u01a1 n\u00e0y \u0111\u1ec3 xem thu\u1ed1c c\u00f3 an to\u00e0n v\u00e0 c\u00f3 hi\u1ec7u qu\u1ea3 hay kh\u00f4ng, \u0111\u1ed3ng th\u1eddi ki\u1ec3m tra nh\u00e0 s\u1ea3n xu\u1ea5t c\u00f3 quy tr\u00ecnh s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ee7 ch\u1eb7t \u0111\u1ec3 gi\u1eef \u1ed5n \u0111\u1ecbnh ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m hay kh\u00f4ng.<\/span><\/p>\n

N\u1ebfu b\u1ea1n m\u1edbi t\u00ecm hi\u1ec3u, h\u00e3y nh\u1edb 4 nh\u00f3m n\u1ed9i dung ch\u00ednh FDA s\u1ebd xem:<\/span><\/p>\n

    \n
  1. An to\u00e0n\u00a0<\/span><\/li>\n
  2. Hi\u1ec7u qu\u1ea3\u00a0<\/span><\/li>\n
  3. Nh\u00e3n v\u00e0 h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng\u00a0<\/span><\/li>\n
  4. S\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng<\/span><\/li>\n<\/ol>\n

    Thu\u1ed1c generic v\u00e0 c\u00e1c con \u0111\u01b0\u1eddng h\u1ed3 s\u01a1 ph\u1ed5 bi\u1ebfn<\/b><\/h3>\n

    Thu\u1ed1c generic, th\u01b0\u1eddng \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 thu\u1ed1c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng ho\u1eb7c thu\u1ed1c sao ch\u00e9p, th\u01b0\u1eddng n\u1ed9p h\u1ed3 s\u01a1 theo d\u1ea1ng <\/span>ANDA<\/b><\/a>, t\u00ean \u0111\u1ea7y \u0111\u1ee7 l\u00e0 Abbreviated New Drug Application. FDA g\u1ecdi \u0111\u00e2y l\u00e0 h\u1ed3 s\u01a1 r\u00fat g\u1ecdn v\u00ec nh\u00e0 m\u00e1y th\u01b0\u1eddng kh\u00f4ng ph\u1ea3i n\u1ed9p l\u1ea1i to\u00e0n b\u1ed9 d\u1eef li\u1ec7u ti\u1ec1n l\u00e2m s\u00e0ng v\u00e0 l\u00e2m s\u00e0ng \u0111\u1ec3 ch\u1ee9ng minh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 nh\u01b0 thu\u1ed1c m\u1edbi. Thay v\u00e0o \u0111\u00f3, tr\u1ecdng t\u00e2m l\u00e0 ch\u1ee9ng minh thu\u1ed1c c\u00f3 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng \u0111\u01b0\u01a1ng so v\u1edbi thu\u1ed1c \u0111\u01b0\u1ee3c tham chi\u1ebfu kh\u00f4ng.<\/span><\/p>\n

    Ti\u00eau chu\u1ea9n FDA trong d\u01b0\u1ee3c ph\u1ea9m n\u00ean hi\u1ec3u nh\u01b0 th\u1ebf n\u00e0o<\/b><\/h2>\n

    cGMP l\u00e0 tr\u1ecdng t\u00e2m khi n\u00f3i v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng d\u01b0\u1ee3c<\/b><\/h3>\n

    Khi ng\u01b0\u1eddi ta h\u1ecfi ti\u00eau chu\u1ea9n FDA l\u00e0 g\u00ec, trong nh\u00e0 m\u00e1y d\u01b0\u1ee3c c\u00e2u tr\u1ea3 l\u1eddi v\u1eadn h\u00e0nh th\u01b0\u1eddng xoay quanh <\/span>cGMP<\/b><\/a>. Vi\u1ec7c tu\u00e2n th\u1ee7 lu\u00f4n n\u1eb1m \u1edf h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng, h\u1ed3 s\u01a1 th\u1ef1c thi v\u00e0 d\u1eef li\u1ec7u \u0111\u01b0\u1ee3c x\u00e1c th\u1ef1c.<\/span><\/p>\n

    21 CFR l\u00e0 g\u00ec v\u00e0 doanh nghi\u1ec7p c\u1ea7n \u0111\u1ecdc ph\u1ea7n n\u00e0o tr\u01b0\u1edbc<\/b><\/h3>\n

    21 CFR l\u00e0 Title 21 trong B\u1ed9 Quy \u0111\u1ecbnh Li\u00ean bang Hoa K\u1ef3, n\u01a1i ch\u1ee9a nhi\u1ec1u quy \u0111\u1ecbnh li\u00ean quan \u0111\u1ebfn thu\u1ed1c. V\u1edbi ng\u01b0\u1eddi m\u1edbi trong nh\u00e0 m\u00e1y, n\u00ean \u0111\u1ecdc theo nhu c\u1ea7u c\u00f4ng vi\u1ec7c.<\/span><\/p>\n