Th\u00e1ng 3 n\u0103m 2019, ng\u00e0nh D\u01b0\u1ee3c n\u00f3i ri\u00eang v\u00e0 Y t\u1ebf Trung qu\u1ed1c n\u00f3i chung th\u00eam m\u1ed9t l\u1ea7n n\u1eefa \u0111\u1ee9ng tr\u01b0\u1edbc m\u1ed9t thay \u0111\u1ed5i l\u1edbn.
\nQu\u1ed1c v\u1ee5 vi\u1ec7n Trung qu\u1ed1c v\u1eeba ti\u1ebft l\u1ed9 d\u1ef1 th\u1ea3o c\u1ea3i t\u1ed5 th\u00e0nh ph\u1ea7n ch\u00ednh ph\u1ee7, trong \u0111\u00f3 CFDA \u2013 C\u1ee5c qu\u1ea3n l\u00fd D\u01b0\u1ee3c ph\u1ea9m v\u00e0 th\u1ef1c ph\u1ea9m Trung qu\u1ed1c s\u1ebd s\u00e1t nh\u1eadp v\u1edbi t\u1ed5ng c\u1ee5c gi\u00e1m s\u00e1t ki\u1ec3m d\u1ecbch v\u00e0 ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng, c\u01a1 quan qu\u1ea3n l\u00fd qu\u1ea3ng c\u00e1o, b\u1ea3o v\u1ec7 doanh nghi\u1ec7p v\u00e0 ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 tr\u1edf th\u00e0nh U\u1ef7 ban gi\u00e1m s\u00e1t th\u1ecb tr\u01b0\u1eddng qu\u1ed1c gia – State Administration for Market Supervision. D\u1ef1 th\u1ea3o n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t v\u00e0o \u0111\u1ea7u th\u00e1ng 3.2019 trong phi\u00ean h\u1ecdp c\u1ee7a \u0110\u1ea1i h\u1ed9i \u0111\u1ea1i bi\u1ec3u nh\u00e2n d\u00e2n to\u00e0n qu\u1ed1c t\u1ee9c Qu\u1ed1c h\u1ed9i Trung qu\u1ed1c.<\/p>\n
Tr\u01b0\u1edbc \u0111\u00e2y vi\u1ec7c \u0111\u0103ng k\u00fd thu\u1ed1c v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i th\u00f4ng qua C\u1ee5c Th\u01b0\u01a1ng m\u1ea1i v\u00e0 C\u00f4ng nghi\u1ec7p, C\u1ee5c Ki\u1ec3m d\u1ecbch, ki\u1ec3m tra v\u00e0 Gi\u00e1m s\u00e1t ch\u1ea5t l\u01b0\u1ee3ng ch\u1ecbu tr\u00e1ch nhi\u1ec7m qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng. V\u00e0 s\u1eafp t\u1edbi to\u00e0n b\u1ed9 c\u00e1c c\u01a1 quan n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c s\u00e1p nh\u1eadp.
\nC\u1ee5 th\u1ec3 h\u01a1n, CFDA s\u1ebd b\u1ecf m\u1ea3ng th\u1ef1c ph\u1ea9m v\u00e0 tr\u1edf th\u00e0nh CDA \u2013 C\u1ee5c qu\u1ea3n l\u00fd d\u01b0\u1ee3c Trung qu\u1ed1c. V\u0102n ph\u00f2ng CDA s\u1ebd ch\u1ec9 ho\u1ea1t \u0111\u1ed9ng \u1edf c\u1ea5p t\u1ec9nh. C\u00e1c c\u1ea5p th\u00e0nh ph\u1ed1 s\u1ebd b\u1ecb hu\u1ef7 b\u1ecf.<\/p>\n
Trung qu\u1ed1c l\u00e0 th\u1ecb tr\u01b0\u1eddng d\u01b0\u1ee3c ph\u1ea9m l\u1edbn th\u1ee9 hai th\u1ebf gi\u1edbi, \u0111\u1ea1t 126 t\u1ef7 USD n\u0103m 2017. To\u00e0n Trung qu\u1ed1c c\u00f3 5000 c\u00f4ng ty d\u01b0\u1ee3c ph\u1ea9m v\u00e0 k\u1ef3 v\u1ecdng gi\u1ea3m xu\u1ed1ng 1000 sau n\u0103m 2024.<\/p>\n
C\u00f3 th\u1ec3 n\u00f3i ch\u00ednh ph\u1ee7 Trung qu\u1ed1c \u0111\u00e3 quy\u1ebft t\u00e2m thay \u0111\u1ed5i l\u1edbn to\u00e0n ng\u00e0nh y t\u1ebf, d\u01b0\u1ee3c ph\u1ea9m \u0111\u1ec3 c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ea7u th\u1ebf gi\u1edbi trong th\u1eddi gian t\u1edbi, c\u00f9ng v\u1edbi vi\u1ec7c gia nh\u1eadp ICH, c\u1ea3i t\u1ed5 l\u1edbn n\u1ed9i b\u1ed9 v\u00e0 c\u00f3 vai tr\u00f2 quan tr\u1ecdng trong k\u1ebf ho\u1ea1ch Made in China 2025 c\u1ee7a T\u1eadp c\u1eadn b\u00ecnh.<\/p>\n
– Ch\u1ea5p nh\u1eadn d\u1eef li\u1ec7u l\u00e2m s\u00e0ng th\u1eed nghi\u1ec7m b\u00ean ngo\u00e0i l\u00e3nh th\u1ed5 Trung qu\u1ed1c, \u0111\u1ec3 qu\u00e1 tr\u00ecnh ph\u00ea duy\u1ec7t thu\u1ed1c m\u1edbi nhanh h\u01a1n.
\n– \u0110\u01a1n gi\u1ea3n ho\u00e1 quy tr\u00ecnh th\u1eed l\u00e2m s\u00e0ng. Sau khi n\u1ed9p \u0111\u01a1n th\u1eed nghi\u1ec7m v\u00e0 CDA v\u00e0 c\u00e1c t\u1ec9nh kh\u00f4ng \u0111\u01b0a ra b\u1ea5t c\u1ee9 v\u1ea5n \u0111\u1ec1 g\u00ec th\u00ec m\u1eb7c nhi\u00ean \u0111\u01b0\u1ee3c coi l\u00e0 ch\u1ea5p thu\u1eadn v\u00e0 c\u00f3 th\u1ec3 ti\u1ebfn h\u00e0nh th\u1eed l\u00e2m s\u00e0ng.
\n– C\u00e1c c\u00f4ng ty c\u00f3 th\u1ec3 ch\u1ecdn c\u00e1c \u0111\u01a1n v\u1ecb th\u1eed nghi\u1ec7m \u1edf giai \u0111o\u1ea1n phase I, k\u1ec3 c\u1ea3 t\u01b0 nh\u00e2n \u0111\u1ec3 th\u00fac \u0111\u1ea9y c\u1ea1nh tranh v\u00e0 \u0111\u1ea7u t\u01b0 t\u1eeb ph\u00eda c\u00e1c c\u00f4ng ty t\u01b0 nh\u00e2n.
\n– Th\u00fac \u0111\u1ea9y ph\u00ea duy\u1ec7t nhanh h\u01a1n cho c\u00e1c thu\u1ed1c v\u00e0 thi\u1ebft b\u1ecb \u0111\u00e1p \u1ee9ng c\u00e1c nhu c\u1ea7u kh\u1ea9n c\u1ea5p ho\u1eb7c b\u1ec7nh hi\u1ebfm g\u1eb7p.
\n– Tri\u1ec3n khai h\u1ec7 th\u1ed1ng MAH – Market Authorisation Holders. Theo h\u1ec7 th\u1ed1ng m\u1edbi, c\u00e1c MAH s\u1ebd ch\u1ecbu tr\u00e1ch nhi\u1ec7m nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng, th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, s\u1ea3n xu\u1ea5t, ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng nguy\u00ean li\u1ec7u th\u00f4, ph\u00e2n ph\u1ed1i v\u00e0 b\u00e1o c\u00e1o c\u00e1c ph\u1ea3n \u1ee9ng c\u00f3 h\u1ea1i c\u1ee7a thu\u1ed1c. MAH s\u1ebd ch\u1ecbu tr\u00e1ch nhi\u1ec7m ho\u00e0n to\u00e0n cho m\u1ecdi tr\u00e1ch nhi\u1ec7m li\u00ean quan \u0111\u1ebfn thu\u1ed1c. MHA c\u00f3 th\u1ec3 l\u00e0 c\u00e1 nh\u00e2n hay t\u1ed5 ch\u1ee9c, gi\u1eef b\u1ea3n quy\u1ec1n marketing thu\u1ed1c, \u0111\u01b0\u1ee3c thu\u00ea c\u00e1c c\u00f4ng ty gia c\u00f4ng s\u1ea3n xu\u1ea5t.
\nC\u00e1c tr\u00ecnh d\u01b0\u1ee3c vi\u00ean c\u1ee7a c\u00e1c h\u00e3ng thu\u1ed1c v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf s\u1ebd b\u1ecb c\u1ea5m m\u1ecdi c\u00f4ng vi\u1ec7c li\u00ean quan b\u00e1n hang v\u00e0 ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi CDA.
\n– M\u1ecdi thay \u0111\u1ed5i sau ph\u00ea duy\u1ec7t (PAC) ph\u1ea3i \u0111\u01b0\u1ee3c g\u1eedi tr\u1ef1c tuy\u1ebfn v\u00e0 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 b\u1edfi trung t\u00e2m \u0111\u00e1nh gi\u00e1 thu\u1ed1c CDE c\u1ee7a CFDA thay v\u00ec c\u00e1c t\u1ec9nh nh\u01b0 tr\u01b0\u1edbc kia.
\n– Kh\u00e1i ni\u1ec7m \u201cimported drug\u201d \u0111\u1ec1 c\u1eadp \u0111\u1ebfn c\u00e1c thu\u1ed1c s\u1ea3n xu\u1ea5t ngo\u00e0i Trung qu\u1ed1c nh\u01b0ng \u0111\u01b0\u1ee3c \u0111\u01b0\u1ee3c b\u00e1n t\u1ea1i \u0111\u00e2y v\u00e0 c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c mi\u1ec5n ph\u00ed ki\u1ec3m nghi\u1ec7m.
\n– CFDA s\u1ebd ch\u1ea5m d\u1ee9t vi\u1ec7c c\u1ea5p GMP. Vi\u1ec7c t\u00e1i c\u1ea5p GMP 5 n\u0103m m\u1ed9t l\u1ea7n s\u1ebd ch\u1ea5m d\u1ee9t v\u00e0 thay b\u1eb1ng ki\u1ec3m tra th\u01b0\u1eddng xuy\u00ean d\u1ef1a v\u00e0o m\u1ee9c \u0111\u1ed9 r\u1ee7i ro s\u1ebd \u0111\u01b0\u1ee3c CFDA thi\u1ebft l\u1eadp.<\/p>\n
– 21\/11\/1949: th\u00e0nh l\u1eadp b\u1ed9 y t\u1ebf Trung qu\u1ed1c.
\n– 1954: Kh\u1edfi t\u1ea1o k\u1ebf ho\u1ea1ch RCMS – Ch\u01b0\u01a1ng tr\u00ecnh y t\u1ebf h\u1ee3p t\u00e1c x\u00e3 n\u00f4ng th\u00f4n.
\n– 1978: Th\u00e0nh l\u1eadp c\u1ee5c qu\u1ea3n l\u00fd d\u01b0\u1ee3c ph\u1ea9m \u2013 PA thu\u1ed9c b\u1ed9 y t\u1ebf. C\u01a1 quan n\u00e0y h\u1ea7u nh\u01b0 kh\u00f4ng c\u00f3 vai tr\u00f2 g\u00ec trong ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng thu\u1ed1c v\u00e0 ho\u00e0n to\u00e0n b\u1ecb c\u00e1c nh\u00e0 m\u00e1y qu\u1ed1c doanh kh\u1ed1ng ch\u1ebf.
\n– 1984 Ch\u01b0\u01a1ng tr\u00ecnh y t\u1ebf h\u1ee3p t\u00e1c x\u00e3 n\u00f4ng th\u00f4n s\u1ee5p \u0111\u1ed5 sau \u0111\u1ee3t c\u1ea3i c\u00e1ch n\u00f4ng nghi\u1ec7p b\u1eaft \u0111\u1ea7u n\u0103m 1980.
\n– N\u0103m 1997, ch\u00ednh ph\u1ee7 Trung Qu\u1ed1c \u0111\u01b0a ra quy\u1ebft \u0111\u1ecbnh c\u1ea3i c\u00e1ch ph\u00e1t tri\u1ec3n c\u00e1c v\u1ea5n \u0111\u1ec1 v\u1ec7 sinh d\u1ecbch t\u1ec5. Ch\u00ednh s\u00e1ch c\u1ea3i c\u00e1ch ph\u00e1t tri\u1ec3n c\u1ee7a n\u01b0\u1edbc n\u00e0y \u0111\u00e3 n\u00eau r\u00f5: “Th\u1ef1c hi\u1ec7n Y \u2013 D\u01b0\u1ee3c ph\u00e2n ly \u0111\u1ec3 h\u1ea1ch to\u00e1n, chia ra qu\u1ea3n l\u00fd”.
\n– 1998: th\u00e0nh l\u1eadp C\u1ee5c qu\u1ea3n l\u00fd D\u01b0\u1ee3c nh\u00e0 n\u01b0\u1edbc Trung qu\u1ed1c \u2013 SDA tr\u1ef1c thu\u1ed9c Qu\u1ed1c v\u1ee5 vi\u1ec7n.
\n– 1998: Th\u00e0nh l\u1eadp CDC \u2013 trung t\u00e2m ph\u00f2ng ch\u1ed1ng v\u00e0 ki\u1ec3m so\u00e1t b\u1ec7nh t\u1eadt Trung qu\u1ed1c tr\u1ef1c thu\u1ed9c b\u1ed9 y t\u1ebf.
\n– 2002: kh\u1edfi t\u1ea1o Ch\u01b0\u01a1ng tr\u00ecnh y t\u1ebf h\u1ee3p t\u00e1c x\u00e3 n\u00f4ng th\u00f4n m\u1edbi \u2013 NRCMS. \u0110\u1ec9nh cao c\u00f3 h\u01a1n 90% d\u00e2n s\u1ed1 \u0111\u00e3 tham gia NRDMS.
\n– 2016: NRCMS s\u00e1t nh\u1eadp v\u1edbi URBMS – Ch\u01b0\u01a1ng tr\u00ecnh y t\u1ebf c\u01a1 b\u1ea3n cho c\u01b0 d\u00e2n \u0111\u00f4 th\u1ecb th\u00e0nh m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh chung.
\n– 2003: SDA \u0111\u01b0\u1ee3c th\u00eam v\u00e0o c\u00e1c ch\u1ee9c n\u0103ng v\u1ec1 qu\u1ea3n l\u00fd th\u1ef1c ph\u1ea9m, m\u1ef9 ph\u1ea9m, s\u1ea3n ph\u1ea9m dinh d\u01b0\u1ee1ng v\u00e0 tr\u1edf th\u00e0nh SFDA.
\n– 7\/2007: c\u1ee5c tr\u01b0\u1edfng c\u1ee5c Qu\u1ea3n l\u00fd d\u01b0\u1ee3c SFDA Tr\u1ecbnh Ti\u00eau Du b\u1ecb x\u1eed t\u1eed sau b\u00ea b\u1ed1i c\u1ea5p ph\u00e9p thu\u1ed1c gi\u1ea3.
\n– 2007: C\u1ee5c qu\u1ea3n l\u00fd d\u01b0\u1ee3c b\u1ecb b\u1ed9 y t\u1ebf th\u00e2u t\u00f3m.
\n– 3\/2008: th\u00e0nh l\u1eadp B\u1ed9 An sinh x\u00e3 h\u1ed9i v\u00e0 Nh\u00e2n l\u1ef1c.
\n– 2009: L\u1ea7n \u0111\u1ea7u ban h\u00e0nh danh m\u1ee5c thu\u1ed1c thi\u1ebft y\u1ebfu \u2013 EDL g\u1ed3m 307 lo\u1ea1i thu\u1ed1c \u0111\u01b0\u1ee3c \u0111\u00e0m ph\u00e1n gi\u1eefa nh\u00e0 n\u01b0\u1edbc v\u00e0 c\u00e1c c\u00f4ng ty \u0111\u1ec3 b\u00e1n \u0111\u1ed9c quy\u1ec1n, v\u1edbi gi\u00e1 th\u1ea5p nh\u1ea5t t\u1ea1i c\u00e1c c\u01a1 s\u1edf y t\u1ebf. Trong khi \u0111\u00f3 c\u00e1c c\u00f4ng ty d\u01b0\u1ee3c \u0111\u1ec1u \u0111\u00e1nh g\u00eda ch\u01b0\u01a1ng tr\u00ecnh thu\u1ed1c thi\u1ebft y\u1ebfu \u0111\u00e3 t\u00e1c \u0111\u1ed9ng ti\u00eau c\u1ef1c t\u1edbi ho\u1ea1t \u0111\u1ed9ng kinh doanh c\u1ee7a h\u1ecd.
\n– 2013: C\u1ee5c qu\u1ea3n l\u00fd d\u01b0\u1ee3c \u0111\u1ed9c l\u1eadp kh\u1ecfi b\u1ed9 y t\u1ebf v\u00e0 \u0111\u01b0\u1ee3c gi\u00e1m s\u00e1t tr\u1ef1c ti\u1ebfp b\u1edfi Qu\u1ed1c v\u1ee5 vi\u1ec7n t\u1ee9c Ch\u00ednh ph\u1ee7 Trung qu\u1ed1c \u2013 CFDA.
\n– 3\/2013: B\u1ed9 Y t\u1ebf c\u00f9ng \u1ee6y ban D\u00e2n s\u1ed1 v\u00e0 K\u1ebf ho\u1ea1ch h\u00f3a gia \u0111\u00ecnh \u0111\u00e3 s\u00e1p nh\u1eadp l\u1ea1i th\u00e0nh \u1ee6y ban K\u1ebf ho\u1ea1ch h\u00f3a Gia \u0111\u00ecnh v\u00e0 Y t\u1ebf qu\u1ed1c gia.
\n– 2016: thi\u1ebft l\u1eadp ch\u01b0\u01a1ng tr\u00ecnh \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng thu\u1ed1c generic \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1n ngo\u00e0i th\u1ecb tr\u01b0\u1eddng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o t\u01b0\u01a1ng \u0111\u01b0\u01a1ng \u0111i\u1ec1u tr\u1ecb.
\n– 2016: Tri\u1ec3n khai th\u00ed \u0111i\u1ec3m MHA. NG\u01b0\u1eddi gi\u1eef b\u1ea3n quy\u1ec1n marketing thu\u1ed1c c\u00f3 th\u1ec3 l\u00e0 c\u00e1 nh\u00e2n hay t\u1ed5 ch\u1ee9c, \u0111\u01b0\u1ee3c thu\u00ea c\u00e1c nh\u00e0 m\u00e1y gia c\u00f4ng h\u00e0ng.
\n– 2017: Y\u00eau c\u1ea7u c\u00e1c thu\u1ed1c generic m\u1edbi ph\u1ea3i \u0111\u1ea1t t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc.
\n– 6\/2017: CFDA gia nh\u1eadp ICH. D\u1ef1 \u0111o\u00e1n sau 4 n\u0103m, s\u1ed1 c\u00f4ng ty d\u01b0\u1ee3c ph\u1ea9m gi\u1ea3m d\u01b0\u1edbi 1000.
\n– 9\/2017: H\u00ecnh th\u00e0nh b\u1ea3n nh\u00e1p Orange book.
\n– 3\/2018: Gi\u1ea3i th\u1ec3 \u1ee6y ban K\u1ebf ho\u1ea1ch h\u00f3a Gia \u0111\u00ecnh v\u00e0 Y t\u1ebf qu\u1ed1c gia v\u00e0 th\u00e0nh l\u1eadp U\u1ef7 ban y t\u1ebf qu\u1ed1c gia NHC.
\n– 29\/8\/2018: TR\u00ean trang web ch\u00ednh th\u1ee9c c\u1ee7a CFDA \u0111\u00e3 th\u00f4ng b\u00e1o t\u00ean ti\u1ebfng Anh c\u1ee7a CFDA \u0111\u1ed5i th\u00e0nh \u201cNational Medical Products Administration \u201cNMPA\u201d v\u00ec th\u1ebf c\u00e1c \u0111\u01a1n \u0111\u0103ng k\u00fd visa m\u1edbi trong th\u00e1ng 9 c\u00f3 th\u1ec3 d\u00f9ng form v\u00e0 t\u00ean m\u1edbi.<\/p>\n
D\u01b0\u1ee3c s\u0129 B\u00ecnh \u0110\u1ecbnh. H\u00e0 N\u1ed9i 27\/2\/19.<\/p>\n
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