{"id":3681,"date":"2020-03-23T15:58:09","date_gmt":"2020-03-23T08:58:09","guid":{"rendered":"http:\/\/new.vientebaogoc.edu.vn\/?post_type=blog_post&p=1175"},"modified":"2024-11-24T07:58:41","modified_gmt":"2024-11-24T00:58:41","slug":"rmat-quy-che-moi-trong-cap-phep-san-pham-y-hoc-tai-tao-o-mi-mot-co-hoi-moi-cho-te-bao-goc-cua-mi","status":"publish","type":"post","link":"https:\/\/sci.edu.vn\/home\/blog\/2020\/03\/23\/rmat-quy-che-moi-trong-cap-phep-san-pham-y-hoc-tai-tao-o-mi-mot-co-hoi-moi-cho-te-bao-goc-cua-mi\/","title":{"rendered":"RMAT: Quy ch\u1ebf m\u1edbi trong c\u1ea5p ph\u00e9p s\u1ea3n ph\u1ea9m y h\u1ecdc t\u00e1i t\u1ea1o \u1edf M\u0129: m\u1ed9t c\u01a1 h\u1ed9i m\u1edbi cho t\u1ebf b\u00e0o g\u1ed1c c\u1ee7a M\u0129"},"content":{"rendered":"\n

L\u0129nh v\u1ef1c y h\u1ecdc t\u00e1i t\u1ea1o bao g\u1ed3m m\u1ed9t lo\u1ea1t c\u00e1c s\u1ea3n ph\u1ea9m s\u00e1ng t\u1ea1o, ti\u00ean ti\u1ebfn bao g\u1ed3m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, c\u00e1c s\u1ea3n ph\u1ea9m k\u1ef9 thu\u1eadt m\u00f4, c\u00e1c t\u1ebf b\u00e0o, m\u00f4 t\u1ebf b\u00e0o v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m k\u1ebft h\u1ee3p c\u00e1c li\u1ec7u ph\u00e1p n\u00e0y. V\u00ed d\u1ee5 nh\u01b0 c\u00e1c li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o bi\u1ebfn \u0111\u1ed5i gen, ch\u1eb3ng h\u1ea1n nh\u01b0 c\u00e1c t\u1ebf b\u00e0o CAR-T v\u00e0 c\u00e1c m\u00f4 c\u1ee7a con ng\u01b0\u1eddi \u0111\u01b0\u1ee3c t\u1ea1o ra t\u1eeb c\u00f4ng ngh\u1ec7 m\u00f4 s\u1eed d\u1ee5ng t\u1ebf b\u00e0o g\u1ed1c. Nh\u1eefng s\u1ea3n ph\u1ea9m n\u00e0y h\u1ee9a h\u1eb9n r\u1ea5t l\u1edbn trong vi\u1ec7c gi\u1ea3i quy\u1ebft c\u00e1c nhu c\u1ea7u y t\u1ebf. V\u00ed d\u1ee5, d\u1eef li\u1ec7u t\u1eeb m\u1ed9t s\u1ed1 nghi\u00ean c\u1ee9u \u0111\u00e3 c\u00f4ng b\u1ed1 kh\u00e1c nhau cho th\u1ea5y ti\u1ec1m n\u0103ng c\u1ee7a c\u00e1c t\u1ebf b\u00e0o CAR-T trong vi\u1ec7c \u0111i\u1ec1u tr\u1ecb m\u1ed9t s\u1ed1 lo\u1ea1i ung th\u01b0 m\u00e1u t\u00e1i ph\u00e1t.<\/strong><\/em><\/strong><\/p>\n\n\n\n

\"\"
\u00d4ng Peter Marks, Gi\u00e1m \u0111\u1ed1c Trung t\u00e2m Nghi\u00ean c\u1ee9u v\u00e0 \u0110\u00e1nh gi\u00e1 Ch\u1ebf ph\u1ea9m Sinh h\u1ecdc t\u1ea1i FDA, Hoa K\u00ec. <\/strong><\/em><\/strong><\/figcaption><\/figure>\n\n\n\n

Nh\u1eadn th\u1ee9c t\u1ea7m quan tr\u1ecdng c\u1ee7a l\u0129nh v\u1ef1c n\u00e0y, Qu\u1ed1c h\u1ed9i M\u0129 \u0111\u00e3 \u0111\u01b0a ra m\u1ed9t s\u1ed1 \u0111i\u1ec1u kho\u1ea3n li\u00ean quan \u0111\u1ebfn y h\u1ecdc t\u00e1i t\u1ea1o trong \u0110\u1ea1o lu\u1eadt Ch\u1eefa tr\u1ecb Th\u1ebf k\u1ef7 21 (21st Century Cures Act), \u0111\u01b0\u1ee3c k\u00fd k\u1ebft v\u00e0o ng\u00e0y 13 th\u00e1ng 12 n\u0103m 2016. Tr\u00ean c\u01a1 s\u1edf c\u00e1c ch\u01b0\u01a1ng tr\u00ecnh kh\u1ea9n c\u1ea5p hi\u1ec7n c\u00f3 c\u1ee7a FDA d\u00e0nh cho c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c t\u00e1i t\u1ea1o, m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh m\u1edbi nh\u1eb1m gi\u00fap th\u00fac \u0111\u1ea9y s\u1ef1 ph\u00e1t tri\u1ec3n v\u00e0 s\u1ef1 ch\u1ea5p thu\u1eadn c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m y h\u1ecdc t\u00e1i t\u1ea1o l\u00e0: Ch\u1ec9 \u0111\u1ecbnh li\u1ec7u ph\u00e1p ti\u00ean ti\u1ebfn Y h\u1ecdc t\u00e1i t\u1ea1o (Regenerative Medicine Advanced Therapy (RMAT) Designation – RMAT).

C\u00e1c c\u00f4ng ty s\u1ea3n xu\u1ea5t c\u00e1c li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, s\u1ea3n ph\u1ea9m m\u00f4 t\u1ebf b\u00e0o tr\u1ecb li\u1ec7u, s\u1ea3n ph\u1ea9m m\u00f4 t\u1ebf b\u00e0o v\u00e0 s\u1ea3n ph\u1ea9m m\u00f4 c\u1ee7a con ng\u01b0\u1eddi, v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m k\u1ebft h\u1ee3p nh\u1ea5t \u0111\u1ecbnh c\u00f3 th\u1ec3 \u0111\u0103ng k\u00ed Ch\u1ec9 \u0111\u1ecbnh RMAT cho s\u1ea3n ph\u1ea9m c\u1ee7a h\u1ecd n\u1ebfu thu\u1ed1c \u0111\u01b0\u1ee3c d\u00f9ng \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb c\u00e1c b\u1ec7nh ho\u1eb7c c\u00e1c \u0111i\u1ec1u ki\u1ec7n nguy hi\u1ec3m ho\u1eb7c \u0111e d\u1ecda \u0111\u1ebfn m\u1ea1ng s\u1ed1ng v\u00e0 n\u1ebfu c\u00f3 s\u01a1 b\u1ed9 b\u1eb1ng ch\u1ee9ng l\u00e2m s\u00e0ng ch\u1ec9 ra r\u1eb1ng thu\u1ed1c \u0111\u00f3 c\u00f3 kh\u1ea3 n\u0103ng \u0111\u00e1p \u1ee9ng c\u00e1c nhu c\u1ea7u y t\u1ebf m\u00e0 ch\u01b0a \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng cho b\u1ec7nh ho\u1eb7c t\u00ecnh tr\u1ea1ng \u0111\u00f3 b\u1edfi c\u00e1c ph\u01b0\u01a1ng ph\u00e1p hi\u1ec7n t\u1ea1i.<\/p>\n\n\n\n

C\u00e1c c\u00f4ng ty s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh RMAT c\u00f3 th\u1ec3 h\u1ed9i \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n cho c\u00e1c t\u01b0\u01a1ng t\u00e1c v\u1edbi FDA. Ngo\u00e0i ra, h\u1ecd c\u00f3 th\u1ec3 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u1ec3 \u0111\u01b0\u1ee3c xem x\u00e9t \u01b0u ti\u00ean v\u00e0 nhanh ch\u00f3ng ph\u00ea duy\u1ec7t.<\/p>\n\n\n\n


Sau khi \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn, khi th\u00edch h\u1ee3p, FDA c\u00f3 th\u1ec3 cho ph\u00e9p th\u1ef1c hi\u1ec7n c\u00e1c y\u00eau c\u1ea7u sau khi ph\u00ea duy\u1ec7t theo s\u1ef1 ch\u1ea5p thu\u1eadn nhanh ch\u00f3ng th\u00f4ng qua vi\u1ec7c n\u1ed9p b\u1eb1ng ch\u1ee9ng l\u00e2m s\u00e0ng, nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng, \u0111\u0103ng k\u00fd b\u1ec7nh nh\u00e2n, ho\u1eb7c c\u00e1c ngu\u1ed3n b\u1eb1ng ch\u1ee9ng th\u1ef1c t\u1ebf kh\u00e1c nh\u01b0 h\u1ed3 s\u01a1 s\u1ee9c kho\u1ebb; th\u00f4ng qua vi\u1ec7c thu th\u1eadp c\u00e1c t\u1eadp d\u1eef li\u1ec7u x\u00e1c nh\u1eadn l\u1edbn h\u01a1n; Ho\u1eb7c th\u00f4ng qua gi\u00e1m s\u00e1t sau khi ch\u1ea5p thu\u1eadn c\u1ee7a t\u1ea5t c\u1ea3 c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng li\u1ec7u ph\u00e1p tr\u01b0\u1edbc khi ph\u00ea duy\u1ec7t.

Trung t\u00e2m Nghi\u00ean c\u1ee9u v\u00e0 \u0110\u00e1nh gi\u00e1 sinh h\u1ecdc c\u1ee7a FDA cam k\u1ebft gi\u00fap \u0111\u1ee1 c\u00e1c li\u1ec7u ph\u00e1p ti\u00ean ti\u1ebfn v\u1ec1 y h\u1ecdc t\u00e1i t\u1ea1o \u0111\u01b0\u1ee3c ch\u1ee9ng minh l\u00e0 an to\u00e0n v\u00e0 c\u00f3 hi\u1ec7u qu\u1ea3 c\u00e0ng s\u1edbm c\u00e0ng t\u1ed1t, \u0111\u1eb7c bi\u1ec7t \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n b\u1ecb b\u1ec7nh ho\u1eb7c \u0111i\u1ec1u ki\u1ec7n \u0111e d\u1ecda \u0111\u1ebfn m\u1ea1ng s\u1ed1ng ho\u1eb7c \u0111i\u1ec1u ki\u1ec7n thi\u1ebfu c\u00e1c l\u1ef1a ch\u1ecdn \u0111i\u1ec1u tr\u1ecb kh\u00e1c.
 <\/p>\n\n\n\n

\u0110i\u1ec1u c\u1ea7n l\u01b0u \u00fd r\u1eb1ng RMAT kh\u00f4ng t\u01b0\u01a1ng \u0111\u01b0\u01a1ng FDA. N\u00f3 l\u00e0 m\u1ed9t b\u01b0\u1edbc ti\u1ebfn m\u1edbi trong qu\u1ea3n l\u00ed \u0111\u1ec3 c\u00e1c s\u1ea3n ph\u1ea9m y h\u1ecdc t\u00e1i t\u1ea1o v\u00e0 t\u1ebf b\u00e0o g\u1ed1c c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn \u0111\u01b0a va\u00e0o \u1ee9ng d\u1ee5ng.<\/p>\n\n\n\n

Sau v\u00e0i th\u00e1ng RMAT c\u00f3 hi\u1ec7u l\u1ef1c, \u0111\u00e3 c\u00f3 \u00edt nh\u1ea5t 03 s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c RMAT c\u1ea5p ph\u00e9p \u0111\u1ec3 s\u1eed d\u1ee5ng bao g\u1ed3m:<\/p>\n\n\n\n

  • Humancyte<\/li>
  • Enzyvant<\/li>
  • jCyte<\/li><\/ul>\n\n\n\n

    (Ph\u1ea1m V\u0169)<\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

    L\u0129nh v\u1ef1c y h\u1ecdc t\u00e1i t\u1ea1o bao g\u1ed3m m\u1ed9t lo\u1ea1t c\u00e1c s\u1ea3n ph\u1ea9m s\u00e1ng t\u1ea1o, ti\u00ean ti\u1ebfn bao g\u1ed3m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, c\u00e1c s\u1ea3n ph\u1ea9m k\u1ef9 thu\u1eadt m\u00f4, c\u00e1c t\u1ebf b\u00e0o, m\u00f4 t\u1ebf b\u00e0o v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m k\u1ebft h\u1ee3p c\u00e1c li\u1ec7u ph\u00e1p n\u00e0y. V\u00ed d\u1ee5 nh\u01b0 c\u00e1c li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o bi\u1ebfn \u0111\u1ed5i […]<\/p>\n","protected":false},"author":293,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"advanced_seo_description":"","jetpack_seo_html_title":"","jetpack_seo_noindex":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[161],"tags":[],"class_list":["post-3681","post","type-post","status-publish","format-standard","hentry","category-ban-tin"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts\/3681","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/users\/293"}],"replies":[{"embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/comments?post=3681"}],"version-history":[{"count":1,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts\/3681\/revisions"}],"predecessor-version":[{"id":4474,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/posts\/3681\/revisions\/4474"}],"wp:attachment":[{"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/media?parent=3681"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/categories?post=3681"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sci.edu.vn\/home\/wp-json\/wp\/v2\/tags?post=3681"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}