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资(Zi)讯(Xun)中(Zhong)心(Xin)
《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)出(Chu)台(Tai),(?) 2025年(Nian)1月(Yue)1日(Ri)起(Qi)施(Shi)行(Xing)
- 分(Fen)类(Lei):(?)行(Xing)业(Ye)新(Xin)闻(Wen)
- 作(Zuo)者(Zhe):(?)政(Zheng)策(Ce)
- 来(Lai)源(Yuan):(?)国(Guo)家(Jia)药(Yao)监(Jian)局(Ju)官(Guan)网(Wang)
- 发(Fa)布(Bu)时(Shi)间(Jian):(?)2024-07-30 17:38
- 访(Fang)问(Wen)量(Liang):(?)
【(?)概(Gai)要(Yao)描(Miao)述(Shu)】(?)导(Dao)读(Du):(?)附(Fu)政(Zheng)策(Ce)解(Jie)读(Du)
7月(Yue)10日(Ri),(?)国(Guo)家(Jia)药(Yao)监(Jian)局(Ju)发(Fa)布(Bu)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)((?)以(Yi)下(Xia)简(Jian)称(Cheng)《(?)规(Gui)定(Ding)》(?))(?),(?)自(Zi)2025年(Nian)1月(Yue)1日(Ri)起(Qi)施(Shi)行(Xing)。(?)
《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)出(Chu)台(Tai),(?) 2025年(Nian)1月(Yue)1日(Ri)起(Qi)施(Shi)行(Xing)
【(?)概(Gai)要(Yao)描(Miao)述(Shu)】(?)导(Dao)读(Du):(?)附(Fu)政(Zheng)策(Ce)解(Jie)读(Du)
7月(Yue)10日(Ri),(?)国(Guo)家(Jia)药(Yao)监(Jian)局(Ju)发(Fa)布(Bu)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)((?)以(Yi)下(Xia)简(Jian)称(Cheng)《(?)规(Gui)定(Ding)》(?))(?),(?)自(Zi)2025年(Nian)1月(Yue)1日(Ri)起(Qi)施(Shi)行(Xing)。(?)
- 分(Fen)类(Lei):(?)行(Xing)业(Ye)新(Xin)闻(Wen)
- 作(Zuo)者(Zhe):(?)政(Zheng)策(Ce)
- 来(Lai)源(Yuan):(?)国(Guo)家(Jia)药(Yao)监(Jian)局(Ju)官(Guan)网(Wang)
- 发(Fa)布(Bu)时(Shi)间(Jian):(?)2024-07-30 17:38
- 访(Fang)问(Wen)量(Liang):(?)
7月(Yue)10日(Ri),(?)国(Guo)家(Jia)药(Yao)监(Jian)局(Ju)发(Fa)布(Bu)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)((?)以(Yi)下(Xia)简(Jian)称(Cheng)《(?)规(Gui)定(Ding)》(?))(?),(?)自(Zi)2025年(Nian)1月(Yue)1日(Ri)起(Qi)施(Shi)行(Xing)。(?)
图(Tu)片(Pian)来(Lai)源(Yuan):(?)国(Guo)家(Jia)药(Yao)监(Jian)局(Ju)官(Guan)网(Wang)
药(Yao)品(Pin)标(Biao)准(Zhun)是(Shi)保(Bao)障(Zhang)药(Yao)品(Pin)安(An)全(Quan)有(You)效(Xiao)的(De)重(Zhong)要(Yao)基(Ji)础(Chu)。(?)《(?)规(Gui)定(Ding)》(?)将(Jiang)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)的(De)一(Yi)般(Ban)性(Xing)程(Cheng)序(Xu)与(Yu)中(Zhong)药(Yao)自(Zi)身(Shen)特(Te)殊(Shu)性(Xing)相(Xiang)结(Jie)合(He),(?)对(Dui)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)的(De)共(Gong)性(Xing)问(Wen)题(Ti)、(?)难(Nan)点(Dian)问(Wen)题(Ti),(?)从(Cong)政(Zheng)策(Ce)、(?)技(Ji)术(Shu)层(Ceng)面(Mian)做(Zuo)出(Chu)规(Gui)定(Ding),(?)其(Qi)出(Chu)台(Tai)对(Dui)于(Yu)加(Jia)强(Qiang)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li),(?)建(Jian)立(Li)符(Fu)合(He)中(Zhong)医(Yi)药(Yao)特(Te)点(Dian)的(De)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)体(Ti)系(Xi),(?)推(Tui)动(Dong)中(Zhong)药(Yao)产(Chan)业(Ye)高(Gao)质(Zhi)量(Liang)发(Fa)展(Zhan),(?)促(Cu)进(Jin)中(Zhong)医(Yi)药(Yao)传(Chuan)承(Cheng)创(Chuang)新(Xin)发(Fa)展(Zhan)具(Ju)有(You)重(Zhong)要(Yao)意(Yi)义(Yi)。(?)
《(?)规(Gui)定(Ding)》(?)包(Bao)括(Kuo)总(Zong)则(Ze)、(?)基(Ji)本(Ben)要(Yao)求(Qiu)、(?)中(Zhong)药(Yao)材(Cai)标(Biao)准(Zhun)、(?)中(Zhong)药(Yao)饮(Yin)片(Pian)标(Biao)准(Zhun)、(?)中(Zhong)药(Yao)配(Pei)方(Fang)颗(Ke)粒(Li)标(Biao)准(Zhun)与(Yu)中(Zhong)药(Yao)提(Ti)取(Qu)物(Wu)标(Biao)准(Zhun)、(?)中(Zhong)成(Cheng)药(Yao)标(Biao)准(Zhun)、(?)中(Zhong)药(Yao)标(Biao)准(Zhun)修(Xiu)订(Ding)、(?)程(Cheng)序(Xu)与(Yu)实(Shi)施(Shi)、(?)附(Fu)则(Ze)等(Deng)9章(Zhang)62条(Tiao),(?)适(Shi)用(Yong)于(Yu)中(Zhong)药(Yao)材(Cai)、(?)中(Zhong)药(Yao)饮(Yin)片(Pian)、(?)中(Zhong)药(Yao)配(Pei)方(Fang)颗(Ke)粒(Li)、(?)中(Zhong)药(Yao)提(Ti)取(Qu)物(Wu)、(?)中(Zhong)成(Cheng)药(Yao)等(Deng)的(De)国(Guo)家(Jia)药(Yao)品(Pin)标(Biao)准(Zhun)、(?)药(Yao)品(Pin)注(Zhu)册(Ce)标(Biao)准(Zhun)和(He)省(Sheng)级(Ji)中(Zhong)药(Yao)标(Biao)准(Zhun)的(De)管(Guan)理(Li)。(?)
《(?)规(Gui)定(Ding)》(?)明(Ming)确(Que)了(Liao)中(Zhong)药(Yao)标(Biao)准(Zhun)工(Gong)作(Zuo)的(De)主(Zhu)要(Yao)原(Yuan)则(Ze),(?)强(Qiang)调(Diao)坚(Jian)持(Chi)传(Chuan)承(Cheng)与(Yu)创(Chuang)新(Xin)并(Bing)重(Zhong),(?)遵(Zun)循(Xun)中(Zhong)医(Yi)药(Yao)理(Li)论(Lun),尊(Zun)重(Zhong)传(Chuan)统(Tong)经(Jing)验(Yan),体(Ti)现(Xian)中(Zhong)药(Yao)特(Te)点(Dian),鼓(Gu)励(Li)新(Xin)技(Ji)术(Shu)和(He)新(Xin)方(Fang)法(Fa)在(Zai)中(Zhong)药(Yao)标(Biao)准(Zhun)中(Zhong)应(Ying)用(Yong),(?)支(Zhi)持(Chi)采(Cai)用(Yong)大(Da)数(Shu)据(Ju)、(?)人(Ren)工(Gong)智(Zhi)能(Neng)等(Deng)先(Xian)进(Jin)技(Ji)术(Shu),(?)持(Chi)续(Xu)提(Ti)高(Gao)中(Zhong)药(Yao)质(Zhi)量(Liang)可(Ke)控(Kong)性(Xing)。(?)《(?)规(Gui)定(Ding)》(?)指(Zhi)出(Chu),(?)中(Zhong)药(Yao)材(Cai)、(?)中(Zhong)药(Yao)饮(Yin)片(Pian)、(?)中(Zhong)药(Yao)配(Pei)方(Fang)颗(Ke)粒(Li)、(?)中(Zhong)药(Yao)提(Ti)取(Qu)物(Wu)、(?)中(Zhong)成(Cheng)药(Yao)等(Deng)的(De)药(Yao)品(Pin)标(Biao)准(Zhun)在(Zai)质(Zhi)量(Liang)控(Kong)制(Zhi)理(Li)念(Nian)、(?)技(Ji)术(Shu)要(Yao)求(Qiu)、(?)生(Sheng)产(Chan)质(Zhi)量(Liang)管(Guan)理(Li)等(Deng)方(Fang)面(Mian)应(Ying)当(Dang)保(Bao)持(Chi)协(Xie)调(Diao),(?)注(Zhu)重(Zhong)彼(Bi)此(Ci)之(Zhi)间(Jian)内(Nei)在(Zai)质(Zhi)量(Liang)的(De)关(Guan)联(Lian)性(Xing)。(?)《(?)规(Gui)定(Ding)》(?)表(Biao)示(Shi),(?)鼓(Gu)励(Li)和(He)支(Zhi)持(Chi)企(Qi)业(Ye)、(?)社(She)会(Hui)第(Di)三(San)方(Fang)积(Ji)极(Ji)参(Can)与(Yu)中(Zhong)药(Yao)标(Biao)准(Zhun)的(De)研(Yan)究(Jiu)和(He)提(Ti)高(Gao)。(?)
《(?)规(Gui)定(Ding)》(?)提(Ti)出(Chu)了(Liao)标(Biao)准(Zhun)研(Yan)究(Jiu)用(Yong)样(Yang)品(Pin)、(?)检(Jian)测(Ce)指(Zhi)标(Biao)及(Ji)检(Jian)测(Ce)成(Cheng)份(Fen)含(Han)量(Liang)限(Xian)度(Du)确(Que)定(Ding)、(?)标(Biao)准(Zhun)物(Wu)质(Zhi)以(Yi)及(Ji)国(Guo)家(Jia)标(Biao)准(Zhun)与(Yu)注(Zhu)册(Ce)标(Biao)准(Zhun)、(?)省(Sheng)级(Ji)标(Biao)准(Zhun)的(De)协(Xie)调(Diao)等(Deng)方(Fang)面(Mian)的(De)基(Ji)本(Ben)要(Yao)求(Qiu),(?)其(Qi)中(Zhong)明(Ming)确(Que)提(Ti)出(Chu)可(Ke)优(You)先(Xian)制(Zhi)定(Ding)中(Zhong)药(Yao)国(Guo)家(Jia)药(Yao)品(Pin)标(Biao)准(Zhun)的(De)三(San)种(Zhong)具(Ju)体(Ti)情(Qing)形(Xing),(?)即(Ji):(?)体(Ti)现(Xian)中(Zhong)医(Yi)药(Yao)特(Te)色(Se)和(He)优(You)势(Shi)的(De)品(Pin)种(Zhong);(?)《(?)国(Guo)家(Jia)基(Ji)本(Ben)医(Yi)疗(Liao)保(Bao)险(Xian)、(?)工(Gong)伤(Shang)保(Bao)险(Xian)和(He)生(Sheng)育(Yu)保(Bao)险(Xian)药(Yao)品(Pin)目(Mu)录(Lu)》(?)或(Huo)者(Zhe)《(?)国(Guo)家(Jia)基(Ji)本(Ben)药(Yao)物(Wu)目(Mu)录(Lu)》(?)收(Shou)载(Zai)的(De)品(Pin)种(Zhong);(?)其(Qi)他(Ta)需(Xu)要(Yao)优(You)先(Xian)制(Zhi)定(Ding)国(Guo)家(Jia)药(Yao)品(Pin)标(Biao)准(Zhun)的(De)品(Pin)种(Zhong)。(?)
按(An)照(Zhao)中(Zhong)药(Yao)材(Cai)、(?)中(Zhong)药(Yao)饮(Yin)片(Pian)、(?)中(Zhong)药(Yao)配(Pei)方(Fang)颗(Ke)粒(Li)与(Yu)中(Zhong)药(Yao)提(Ti)取(Qu)物(Wu)、(?)中(Zhong)成(Cheng)药(Yao)的(De)产(Chan)品(Pin)属(Shu)性(Xing)分(Fen)类(Lei),(?)《(?)规(Gui)定(Ding)》(?)设(She)立(Li)专(Zhuan)门(Men)章(Zhang)节(Jie),(?)分(Fen)别(Bie)明(Ming)确(Que)标(Biao)准(Zhun)研(Yan)究(Jiu)和(He)制(Zhi)定(Ding)所(Suo)关(Guan)注(Zhu)的(De)重(Zhong)点(Dian),(?)阐(Chan)述(Shu)标(Biao)准(Zhun)管(Guan)理(Li)具(Ju)体(Ti)要(Yao)求(Qiu),(?)对(Dui)中(Zhong)药(Yao)材(Cai)基(Ji)原(Yuan)管(Guan)理(Li)、(?)进(Jin)口(Kou)药(Yao)材(Cai)标(Biao)准(Zhun)、(?)饮(Yin)片(Pian)通(Tong)用(Yong)名(Ming)称(Cheng)命(Ming)名(Ming)、(?)中(Zhong)成(Cheng)药(Yao)【(?)制(Zhi)法(Fa)】(?)项(Xiang)的(De)定(Ding)位(Wei)等(Deng)问(Wen)题(Ti)进(Jin)行(Xing)说(Shuo)明(Ming)。(?)
《(?)规(Gui)定(Ding)》(?)对(Dui)中(Zhong)药(Yao)标(Biao)准(Zhun)修(Xiu)订(Ding)、(?)标(Biao)准(Zhun)形(Xing)成(Cheng)机(Ji)制(Zhi)、(?)标(Biao)准(Zhun)实(Shi)施(Shi)过(Guo)渡(Du)期(Qi)管(Guan)理(Li)、(?)标(Biao)准(Zhun)实(Shi)施(Shi)情(Qing)况(Kuang)和(He)适(Shi)用(Yong)性(Xing)评(Ping)估(Gu)等(Deng)进(Jin)行(Xing)制(Zhi)度(Du)设(She)计(Ji)。(?)
值(Zhi)得(De)注(Zhu)意(Yi)的(De)是(Shi),(?)为(Wei)了(Liao)进(Jin)一(Yi)步(Bu)优(You)化(Hua)中(Zhong)药(Yao)标(Biao)准(Zhun)形(Xing)成(Cheng)机(Ji)制(Zhi),(?)《(?)规(Gui)定(Ding)》(?)引(Yin)入(Ru)竞(Jing)争(Zheng)机(Ji)制(Zhi)、(?)深(Shen)化(Hua)公(Gong)开(Kai)机(Ji)制(Zhi)、(?)强(Qiang)化(Hua)鼓(Gu)励(Li)机(Ji)制(Zhi)。(?)《(?)规(Gui)定(Ding)》(?)明(Ming)确(Que),(?)中(Zhong)药(Yao)国(Guo)家(Jia)药(Yao)品(Pin)标(Biao)准(Zhun)或(Huo)者(Zhe)省(Sheng)级(Ji)中(Zhong)药(Yao)标(Biao)准(Zhun)的(De)制(Zhi)定(Ding)修(Xiu)订(Ding),(?)一(Yi)般(Ban)按(An)照(Zhao)标(Biao)准(Zhun)研(Yan)究(Jiu)课(Ke)题(Ti)方(Fang)式(Shi)组(Zu)织(Zhi)开(Kai)展(Zhan),(?)公(Gong)开(Kai)征(Zheng)集(Ji)课(Ke)题(Ti)承(Cheng)担(Dan)单(Dan)位(Wei),(?)择(Ze)优(You)选(Xuan)择(Ze)确(Que)定(Ding)承(Cheng)担(Dan)单(Dan)位(Wei),(?)并(Bing)予(Yu)以(Yi)公(Gong)示(Shi)。(?)对(Dui)未(Wei)列(Lie)入(Ru)标(Biao)准(Zhun)研(Yan)究(Jiu)课(Ke)题(Ti)目(Mu)录(Lu)的(De)品(Pin)种(Zhong),(?)有(You)关(Guan)企(Qi)业(Ye)或(Huo)者(Zhe)机(Ji)构(Gou)、(?)团(Tuan)体(Ti)可(Ke)按(An)相(Xiang)关(Guan)技(Ji)术(Shu)要(Yao)求(Qiu)开(Kai)展(Zhan)研(Yan)究(Jiu)后(Hou),(?)直(Zhi)接(Jie)提(Ti)出(Chu)制(Zhi)定(Ding)或(Huo)者(Zhe)修(Xiu)订(Ding)建(Jian)议(Yi),(?)按(An)照(Zhao)相(Xiang)应(Ying)的(De)程(Cheng)序(Xu)审(Shen)核(He)和(He)颁(Ban)布(Bu)实(Shi)施(Shi)。(?)
同(Tong)时(Shi),(?)《(?)规(Gui)定(Ding)》(?)构(Gou)建(Jian)中(Zhong)药(Yao)标(Biao)准(Zhun)快(Kuai)速(Su)修(Xiu)订(Ding)机(Ji)制(Zhi),(?)指(Zhi)出(Chu)涉(She)及(Ji)药(Yao)品(Pin)安(An)全(Quan)或(Huo)者(Zhe)公(Gong)共(Gong)卫(Wei)生(Sheng)等(Deng)重(Zhong)大(Da)突(Tu)发(Fa)事(Shi)件(Jian)以(Yi)及(Ji)用(Yong)于(Yu)重(Zhong)大(Da)疾(Ji)病(Bing)、(?)新(Xin)发(Fa)突(Tu)发(Fa)传(Chuan)染(Ran)病(Bing)、(?)罕(Han)见(Jian)病(Bing)防(Fang)治(Zhi)、(?)儿(?)童(Tong)用(Yong)药(Yao)等(Deng)情(Qing)形(Xing)的(De)中(Zhong)药(Yao)国(Guo)家(Jia)药(Yao)品(Pin)标(Biao)准(Zhun),(?)应(Ying)当(Dang)按(An)照(Zhao)国(Guo)家(Jia)药(Yao)品(Pin)标(Biao)准(Zhun)快(Kuai)速(Su)制(Zhi)定(Ding)和(He)修(Xiu)订(Ding)程(Cheng)序(Xu)办(Ban)理(Li)。(?)
《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)政(Zheng)策(Ce)解(Jie)读(Du)
一(Yi)、(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)制(Zhi)定(Ding)的(De)目(Mu)的(De)和(He)意(Yi)义(Yi)是(Shi)什(Shi)么(Me)?(?)
药(Yao)品(Pin)标(Biao)准(Zhun)是(Shi)保(Bao)障(Zhang)药(Yao)品(Pin)安(An)全(Quan)有(You)效(Xiao)的(De)重(Zhong)要(Yao)基(Ji)础(Chu),(?)是(Shi)药(Yao)品(Pin)监(Jian)管(Guan)工(Gong)作(Zuo)的(De)准(Zhun)绳(Sheng),(?)也(Ye)是(Shi)一(Yi)个(Ge)国(Guo)家(Jia)医(Yi)药(Yao)产(Chan)业(Ye)发(Fa)展(Zhan)和(He)监(Jian)管(Guan)水(Shui)平(Ping)的(De)重(Zhong)要(Yao)体(Ti)现(Xian),(?)在(Zai)药(Yao)品(Pin)监(Jian)管(Guan)体(Ti)系(Xi)和(He)监(Jian)管(Guan)能(Neng)力(Li)现(Xian)代(Dai)化(Hua)建(Jian)设(She)中(Zhong)发(Fa)挥(Hui)着(Zhuo)基(Ji)础(Chu)性(Xing)、(?)引(Yin)领(Ling)性(Xing)作(Zuo)用(Yong)。(?)2023年(Nian)7月(Yue),(?)国(Guo)家(Jia)局(Ju)发(Fa)布(Bu)了(Liao)《(?)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)办(Ban)法(Fa)》(?),(?)第(Di)一(Yi)次(Ci)全(Quan)面(Mian)系(Xi)统(Tong)地(Di)制(Zhi)定(Ding)了(Liao)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)的(De)制(Zhi)度(Du)和(He)要(Yao)求(Qiu),(?)对(Dui)规(Gui)范(Fan)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)工(Gong)作(Zuo),(?)必(Bi)将(Jiang)发(Fa)挥(Hui)重(Zhong)要(Yao)的(De)作(Zuo)用(Yong)。(?)
新(Xin)时(Shi)代(Dai)发(Fa)展(Zhan)中(Zhong)医(Yi)药(Yao),(?)尤(You)其(Qi)是(Shi)在(Zai)如(Ru)何(He)做(Zuo)好(Hao)守(Shou)正(Zheng)创(Chuang)新(Xin),(?)如(Ru)何(He)推(Tui)动(Dong)中(Zhong)药(Yao)产(Chan)业(Ye)高(Gao)质(Zhi)量(Liang)发(Fa)展(Zhan)等(Deng)方(Fang)面(Mian)需(Xu)要(Yao)有(You)新(Xin)思(Si)路(Lu)、(?)新(Xin)举(Ju)措(Cuo)。(?)在(Zai)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)过(Guo)程(Cheng)中(Zhong),(?)需(Xu)要(Yao)将(Jiang)“最(Zui)严(Yan)谨(Jin)的(De)标(Biao)准(Zhun)”要(Yao)求(Qiu)贯(Guan)穿(Chuan)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)全(Quan)链(Lian)条(Tiao),(?)同(Tong)时(Shi)做(Zuo)好(Hao)传(Chuan)承(Cheng)精(Jing)华(Hua),(?)守(Shou)正(Zheng)创(Chuang)新(Xin),(?)建(Jian)立(Li)符(Fu)合(He)中(Zhong)医(Yi)药(Yao)特(Te)点(Dian)的(De)标(Biao)准(Zhun)管(Guan)理(Li)体(Ti)系(Xi),(?)成(Cheng)为(Wei)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)的(De)重(Zhong)要(Yao)课(Ke)题(Ti)。(?)国(Guo)家(Jia)药(Yao)监(Jian)局(Ju)党(Dang)组(Zu)高(Gao)度(Du)重(Zhong)视(Shi)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)工(Gong)作(Zuo),(?)在(Zai)《(?)国(Guo)家(Jia)药(Yao)监(Jian)局(Ju)关(Guan)于(Yu)印(Yin)发(Fa)进(Jin)一(Yi)步(Bu)加(Jia)强(Qiang)中(Zhong)药(Yao)科(Ke)学(Xue)监(Jian)管(Guan)促(Cu)进(Jin)中(Zhong)药(Yao)传(Chuan)承(Cheng)创(Chuang)新(Xin)发(Fa)展(Zhan)若(Ruo)干(Gan)措(Cuo)施(Shi)的(De)通(Tong)知(Zhi)》(?)中(Zhong),(?)对(Dui)“研(Yan)究(Jiu)制(Zhi)定(Ding)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)”提(Ti)出(Chu)明(Ming)确(Que)要(Yao)求(Qiu)。(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)的(De)制(Zhi)定(Ding)和(He)发(Fa)布(Bu),(?)对(Dui)于(Yu)加(Jia)强(Qiang)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li),(?)建(Jian)立(Li)和(He)完(Wan)善(Shan)符(Fu)合(He)中(Zhong)医(Yi)药(Yao)特(Te)点(Dian)的(De)标(Biao)准(Zhun)体(Ti)系(Xi),(?)促(Cu)进(Jin)中(Zhong)医(Yi)药(Yao)传(Chuan)承(Cheng)创(Chuang)新(Xin)发(Fa)展(Zhan),(?)具(Ju)有(You)重(Zhong)要(Yao)意(Yi)义(Yi)。(?)
二(?)、(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)与(Yu)《(?)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)办(Ban)法(Fa)》(?)是(Shi)什(Shi)么(Me)关(Guan)系(Xi)?(?)
对(Dui)于(Yu)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)而(?)言(Yan),(?)《(?)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)办(Ban)法(Fa)》(?)与(Yu)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)是(Shi)“一(Yi)般(Ban)”与(Yu)“特(Te)殊(Shu)”的(De)关(Guan)系(Xi)。(?)《(?)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)办(Ban)法(Fa)》(?)明(Ming)确(Que)了(Liao)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)工(Gong)作(Zuo)的(De)基(Ji)本(Ben)要(Yao)求(Qiu),(?)对(Dui)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)的(De)基(Ji)本(Ben)制(Zhi)度(Du)、(?)工(Gong)作(Zuo)程(Cheng)序(Xu)以(Yi)及(Ji)各(Ge)方(Fang)职(Zhi)责(Ze)作(Zuo)出(Chu)了(Liao)明(Ming)确(Que)规(Gui)定(Ding)。(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)基(Ji)于(Yu)中(Zhong)药(Yao)的(De)自(Zi)身(Shen)特(Te)点(Dian),(?)将(Jiang)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)的(De)一(Yi)般(Ban)性(Xing)程(Cheng)序(Xu)与(Yu)中(Zhong)药(Yao)自(Zi)身(Shen)特(Te)殊(Shu)性(Xing)相(Xiang)结(Jie)合(He)。(?)在(Zai)《(?)药(Yao)品(Pin)标(Biao)准(Zhun)管(Guan)理(Li)办(Ban)法(Fa)》(?)通(Tong)用(Yong)性(Xing)规(Gui)定(Ding)的(De)基(Ji)础(Chu)上(Shang),(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)按(An)照(Zhao)中(Zhong)药(Yao)材(Cai)、(?)中(Zhong)药(Yao)饮(Yin)片(Pian)、(?)中(Zhong)药(Yao)提(Ti)取(Qu)物(Wu)与(Yu)配(Pei)方(Fang)颗(Ke)粒(Li)、(?)中(Zhong)成(Cheng)药(Yao)等(Deng)中(Zhong)药(Yao)产(Chan)品(Pin)属(Shu)性(Xing)分(Fen)类(Lei),(?)进(Jin)一(Yi)步(Bu)对(Dui)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)的(De)各(Ge)项(Xiang)要(Yao)求(Qiu)进(Jin)行(Xing)细(Xi)化(Hua)和(He)明(Ming)确(Que),(?)彰(Zhang)显(Xian)中(Zhong)药(Yao)的(De)特(Te)殊(Shu)性(Xing)。(?)
三(San)、(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)如(Ru)何(He)推(Tui)进(Jin)符(Fu)合(He)中(Zhong)医(Yi)药(Yao)特(Te)点(Dian)的(De)标(Biao)准(Zhun)体(Ti)系(Xi)的(De)构(Gou)建(Jian)?(?)
中(Zhong)药(Yao)是(Shi)在(Zai)中(Zhong)医(Yi)药(Yao)理(Li)论(Lun)指(Zhi)导(Dao)下(Xia)使(Shi)用(Yong)的(De)药(Yao)品(Pin),(?)中(Zhong)药(Yao)标(Biao)准(Zhun)的(De)研(Yan)究(Jiu)、(?)制(Zhi)定(Ding)和(He)管(Guan)理(Li)必(Bi)须(Xu)充(Chong)分(Fen)考(Kao)虑(Lu)到(Dao)中(Zhong)药(Yao)的(De)自(Zi)身(Shen)特(Te)点(Dian)。(?)在(Zai)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)起(Qi)草(Cao)过(Guo)程(Cheng)中(Zhong),(?)将(Jiang)遵(Zun)循(Xun)中(Zhong)医(Yi)药(Yao)理(Li)论(Lun)、(?)尊(Zun)重(Zhong)中(Zhong)医(Yi)药(Yao)传(Chuan)统(Tong),(?)体(Ti)现(Xian)中(Zhong)药(Yao)特(Te)色(Se)作(Zuo)为(Wei)必(Bi)须(Xu)把(Ba)握(Wo)的(De)根(Gen)本(Ben)原(Yuan)则(Ze)。(?)一(Yi)是(Shi)强(Qiang)调(Diao)中(Zhong)药(Yao)材(Cai)标(Biao)准(Zhun)的(De)研(Yan)究(Jiu)和(He)制(Zhi)定(Ding),(?)应(Ying)注(Zhu)重(Zhong)对(Dui)传(Chuan)统(Tong)质(Zhi)量(Liang)评(Ping)价(Jia)方(Fang)法(Fa)进(Jin)行(Xing)研(Yan)究(Jiu)和(He)传(Chuan)承(Cheng),(?)鼓(Gu)励(Li)对(Dui)道(Dao)地(Di)药(Yao)材(Cai)的(De)品(Pin)质(Zhi)特(Te)征(Zheng)进(Jin)行(Xing)系(Xi)统(Tong)评(Ping)价(Jia)和(He)研(Yan)究(Jiu)。(?)二(?)是(Shi)强(Qiang)调(Diao)中(Zhong)药(Yao)饮(Yin)片(Pian)标(Biao)准(Zhun)的(De)研(Yan)究(Jiu)和(He)制(Zhi)定(Ding),(?)应(Ying)当(Dang)注(Zhu)重(Zhong)传(Chuan)统(Tong)炮(Pao)制(Zhi)经(Jing)验(Yan)的(De)研(Yan)究(Jiu)和(He)传(Chuan)承(Cheng),(?)重(Zhong)点(Dian)关(Guan)注(Zhu)炮(Pao)制(Zhi)过(Guo)程(Cheng)及(Ji)炮(Pao)制(Zhi)终(Zhong)点(Dian)的(De)判(Pan)定(Ding),(?)对(Dui)具(Ju)有(You)“减(Jian)毒(Du)增(Zeng)效(Xiao)”以(Yi)及(Ji)“生(Sheng)熟(Shu)异(Yi)治(Zhi)”特(Te)点(Dian)的(De)中(Zhong)药(Yao)饮(Yin)片(Pian),(?)应(Ying)当(Dang)建(Jian)立(Li)针(Zhen)对(Dui)性(Xing)质(Zhi)量(Liang)控(Kong)制(Zhi)方(Fang)法(Fa),(?)科(Ke)学(Xue)合(He)理(Li)设(She)置(Zhi)质(Zhi)量(Liang)控(Kong)制(Zhi)项(Xiang)目(Mu)。(?)三(San)是(Shi)强(Qiang)调(Diao)中(Zhong)成(Cheng)药(Yao)标(Biao)准(Zhun)的(De)研(Yan)究(Jiu)和(He)制(Zhi)定(Ding),(?)应(Ying)当(Dang)根(Gen)据(Ju)功(Gong)能(Neng)主(Zhu)治(Zhi)、(?)“君(Jun)臣(Chen)佐(Zuo)使(Shi)”等(Deng)组(Zu)方(Fang)规(Gui)律(Lu)及(Ji)临(Lin)床(Chuang)使(Shi)用(Yong)情(Qing)况(Kuang),(?)科(Ke)学(Xue)合(He)理(Li)设(She)置(Zhi)质(Zhi)量(Liang)控(Kong)制(Zhi)项(Xiang)目(Mu)。(?)四(Si)是(Shi)强(Qiang)调(Diao)中(Zhong)药(Yao)配(Pei)方(Fang)颗(Ke)粒(Li)标(Biao)准(Zhun)的(De)研(Yan)究(Jiu)和(He)制(Zhi)定(Ding),(?)应(Ying)当(Dang)重(Zhong)点(Dian)关(Guan)注(Zhu)中(Zhong)药(Yao)配(Pei)方(Fang)颗(Ke)粒(Li)与(Yu)传(Chuan)统(Tong)汤(Tang)剂(Ji)基(Ji)本(Ben)质(Zhi)量(Liang)属(Shu)性(Xing)的(De)一(Yi)致(Zhi)性(Xing)。(?)
四(Si)、(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)在(Zai)优(You)化(Hua)中(Zhong)药(Yao)标(Biao)准(Zhun)形(Xing)成(Cheng)机(Ji)制(Zhi)方(Fang)面(Mian)采(Cai)取(Qu)了(Liao)哪(Na)些(Xie)措(Cuo)施(Shi)?(?)
中(Zhong)药(Yao)标(Biao)准(Zhun)形(Xing)成(Cheng)机(Ji)制(Zhi)在(Zai)很(Hen)大(Da)程(Cheng)度(Du)上(Shang)影(Ying)响(Xiang)着(Zhuo)中(Zhong)药(Yao)标(Biao)准(Zhun)工(Gong)作(Zuo)的(De)质(Zhi)量(Liang)和(He)效(Xiao)率(Lu)。(?)为(Wei)进(Jin)一(Yi)步(Bu)优(You)化(Hua)中(Zhong)药(Yao)标(Biao)准(Zhun)形(Xing)成(Cheng)机(Ji)制(Zhi),(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)积(Ji)极(Ji)探(Tan)索(Suo)中(Zhong)药(Yao)标(Biao)准(Zhun)监(Jian)管(Guan)新(Xin)举(Ju)措(Cuo),(?)引(Yin)入(Ru)新(Xin)的(De)工(Gong)作(Zuo)机(Ji)制(Zhi)。(?)一(Yi)是(Shi)引(Yin)入(Ru)竞(Jing)争(Zheng)机(Ji)制(Zhi),(?)对(Dui)中(Zhong)药(Yao)国(Guo)家(Jia)标(Biao)准(Zhun)制(Zhi)修(Xiu)订(Ding)实(Shi)施(Shi)课(Ke)题(Ti)管(Guan)理(Li),(?)各(Ge)相(Xiang)关(Guan)单(Dan)位(Wei)可(Ke)公(Gong)开(Kai)申(Shen)报(Bao),(?)择(Ze)优(You)确(Que)定(Ding)标(Biao)准(Zhun)课(Ke)题(Ti)承(Cheng)担(Dan)单(Dan)位(Wei)。(?)二(?)是(Shi)全(Quan)面(Mian)深(Shen)化(Hua)公(Gong)开(Kai)机(Ji)制(Zhi),(?)强(Qiang)调(Diao)标(Biao)准(Zhun)提(Ti)高(Gao)课(Ke)题(Ti)立(Li)项(Xiang)信(Xin)息(Xi)、(?)起(Qi)草(Cao)单(Dan)位(Wei)、(?)样(Yang)品(Pin)信(Xin)息(Xi)、(?)研(Yan)究(Jiu)草(Cao)案(An)甚(Shen)至(Zhi)审(Shen)核(He)专(Zhuan)家(Jia)及(Ji)审(Shen)核(He)意(Yi)见(Jian)的(De)对(Dui)外(Wai)公(Gong)开(Kai),(?)确(Que)保(Bao)标(Biao)准(Zhun)工(Gong)作(Zuo)公(Gong)开(Kai)、(?)公(Gong)平(Ping)、(?)公(Gong)正(Zheng)。(?)三(San)是(Shi)进(Jin)一(Yi)步(Bu)强(Qiang)化(Hua)鼓(Gu)励(Li)机(Ji)制(Zhi)。(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)严(Yan)格(Ge)落(Luo)实(Shi)《(?)关(Guan)于(Yu)进(Jin)一(Yi)步(Bu)加(Jia)强(Qiang)中(Zhong)药(Yao)科(Ke)学(Xue)监(Jian)管(Guan)促(Cu)进(Jin)中(Zhong)药(Yao)传(Chuan)承(Cheng)创(Chuang)新(Xin)发(Fa)展(Zhan)的(De)若(Ruo)干(Gan)措(Cuo)施(Shi)》(?)的(De)有(You)关(Guan)要(Yao)求(Qiu),(?)将(Jiang)企(Qi)业(Ye)和(He)社(She)会(Hui)第(Di)三(San)方(Fang)直(Zhi)接(Jie)申(Shen)请(Qing)修(Xiu)订(Ding)中(Zhong)药(Yao)国(Guo)家(Jia)标(Biao)准(Zhun)纳(Na)入(Ru)药(Yao)品(Pin)标(Biao)准(Zhun)形(Xing)成(Cheng)机(Ji)制(Zhi)。(?)四(Si)是(Shi)构(Gou)建(Jian)中(Zhong)药(Yao)标(Biao)准(Zhun)快(Kuai)速(Su)修(Xiu)订(Ding)机(Ji)制(Zhi),(?)要(Yao)求(Qiu)制(Zhi)定(Ding)相(Xiang)关(Guan)配(Pei)套(Tao)文(Wen)件(Jian),(?)加(Jia)快(Kuai)相(Xiang)关(Guan)品(Pin)种(Zhong)的(De)中(Zhong)药(Yao)标(Biao)准(Zhun)修(Xiu)订(Ding)工(Gong)作(Zuo)。(?)
五(Wu)、(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)在(Zai)推(Tui)进(Jin)中(Zhong)药(Yao)标(Biao)准(Zhun)协(Xie)调(Diao)管(Guan)理(Li)工(Gong)作(Zuo)方(Fang)面(Mian)采(Cai)取(Qu)了(Liao)哪(Na)些(Xie)措(Cuo)施(Shi)?(?)
中(Zhong)药(Yao)标(Biao)准(Zhun)涉(She)及(Ji)部(Bu)门(Men)较(Jiao)多(Duo),(?)情(Qing)况(Kuang)较(Jiao)为(Wei)复(Fu)杂(Za)。(?)《(?)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)专(Zhuan)门(Men)规(Gui)定(Ding)》(?)重(Zhong)点(Dian)对(Dui)中(Zhong)药(Yao)标(Biao)准(Zhun)管(Guan)理(Li)过(Guo)程(Cheng)中(Zhong)可(Ke)能(Neng)涉(She)及(Ji)的(De)协(Xie)调(Diao)问(Wen)题(Ti)进(Jin)行(Xing)了(Liao)明(Ming)确(Que)。(?)一(Yi)是(Shi)加(Jia)强(Qiang)省(Sheng)级(Ji)中(Zhong)药(Yao)标(Biao)准(Zhun)、(?)中(Zhong)药(Yao)注(Zhu)册(Ce)标(Biao)准(Zhun)和(He)中(Zhong)药(Yao)国(Guo)家(Jia)标(Biao)准(Zhun)的(De)协(Xie)调(Diao),(?)明(Ming)确(Que)需(Xu)制(Zhi)定(Ding)中(Zhong)药(Yao)国(Guo)家(Jia)标(Biao)准(Zhun)和(He)核(He)发(Fa)中(Zhong)药(Yao)注(Zhu)册(Ce)标(Biao)准(Zhun)的(De)情(Qing)形(Xing)。(?)提(Ti)出(Chu)建(Jian)立(Li)中(Zhong)药(Yao)注(Zhu)册(Ce)标(Biao)准(Zhun)、(?)省(Sheng)级(Ji)中(Zhong)药(Yao)标(Biao)准(Zhun)转(Zhuan)化(Hua)中(Zhong)药(Yao)国(Guo)家(Jia)标(Biao)准(Zhun)的(De)工(Gong)作(Zuo)机(Ji)制(Zhi),(?)加(Jia)强(Qiang)各(Ge)类(Lei)标(Biao)准(Zhun)的(De)融(Rong)合(He)与(Yu)转(Zhuan)化(Hua)。(?)二(?)是(Shi)明(Ming)确(Que)中(Zhong)成(Cheng)药(Yao)国(Guo)家(Jia)标(Biao)准(Zhun)修(Xiu)订(Ding)涉(She)及(Ji)上(Shang)市(Shi)后(Hou)变(Bian)更(Geng)管(Guan)理(Li)的(De)衔(Xian)接(Jie)事(Shi)项(Xiang)。(?)对(Dui)中(Zhong)成(Cheng)药(Yao)国(Guo)家(Jia)标(Biao)准(Zhun)中(Zhong)涉(She)及(Ji)的(De)重(Zhong)大(Da)变(Bian)更(Geng)和(He)中(Zhong)等(Deng)变(Bian)更(Geng)的(De),(?)应(Ying)按(An)照(Zhao)上(Shang)市(Shi)后(Hou)变(Bian)更(Geng)管(Guan)理(Li)相(Xiang)应(Ying)规(Gui)定(Ding)获(Huo)得(De)批(Pi)准(Zhun)或(Huo)备(Bei)案(An)后(Hou),(?)可(Ke)对(Dui)标(Biao)准(Zhun)中(Zhong)相(Xiang)关(Guan)内(Nei)容(Rong)进(Jin)行(Xing)修(Xiu)订(Ding);(?)涉(She)及(Ji)微(Wei)小(Xiao)变(Bian)更(Geng)的(De),(?)可(Ke)对(Dui)标(Biao)准(Zhun)相(Xiang)关(Guan)内(Nei)容(Rong)进(Jin)行(Xing)修(Xiu)订(Ding)后(Hou),(?)由(You)药(Yao)品(Pin)生(Sheng)产(Chan)企(Qi)业(Ye)按(An)上(Shang)市(Shi)后(Hou)变(Bian)更(Geng)管(Guan)理(Li)相(Xiang)应(Ying)要(Yao)求(Qiu)进(Jin)行(Xing)年(Nian)报(Bao)即(Ji)可(Ke)。(?)三(San)是(Shi)进(Jin)一(Yi)步(Bu)理(Li)顺(Shun)中(Zhong)药(Yao)通(Tong)用(Yong)名(Ming)称(Cheng)管(Guan)理(Li)机(Ji)制(Zhi)。(?)明(Ming)确(Que)仅(Jin)有(You)注(Zhu)册(Ce)标(Biao)准(Zhun)的(De)中(Zhong)药(Yao)通(Tong)用(Yong)名(Ming)称(Cheng)修(Xiu)订(Ding)的(De)程(Cheng)序(Xu),(?)参(Can)照(Zhao)《(?)药(Yao)品(Pin)注(Zhu)册(Ce)管(Guan)理(Li)办(Ban)法(Fa)》(?)通(Tong)用(Yong)名(Ming)称(Cheng)核(He)准(Zhun)有(You)关(Guan)程(Cheng)序(Xu),(?)由(You)药(Yao)品(Pin)生(Sheng)产(Chan)企(Qi)业(Ye)按(An)照(Zhao)补(Bu)充(Chong)申(Shen)请(Qing)要(Yao)求(Qiu)进(Jin)行(Xing)申(Shen)报(Bao),(?)由(You)药(Yao)品(Pin)审(Shen)评(Ping)中(Zhong)心(Xin)通(Tong)知(Zhi)药(Yao)典(Dian)委(Wei)员(Yuan)会(Hui)核(He)准(Zhun)通(Tong)用(Yong)名(Ming)称(Cheng)并(Bing)提(Ti)供(Gong)相(Xiang)关(Guan)资(Zi)料(Liao),(?)药(Yao)典(Dian)委(Wei)员(Yuan)会(Hui)核(He)准(Zhun)后(Hou)反(Fan)馈(Kui)药(Yao)品(Pin)审(Shen)评(Ping)中(Zhong)心(Xin)。(?)
附(Fu)件(Jian):(?)
责(Ze)任(Ren)编(Bian)辑(Ji):(?)豌(Wan)豆(Dou)射(She)手(Shou)
声(Sheng)明(Ming):(?)本(Ben)文(Wen)系(Xi)药(Yao)智(Zhi)网(Wang)转(Zhuan)载(Zai)内(Nei)容(Rong),(?)图(Tu)片(Pian)、(?)文(Wen)字(Zi)版(Ban)权(Quan)归(Gui)原(Yuan)作(Zuo)者(Zhe)所(Suo)有(You),(?)转(Zhuan)载(Zai)目(Mu)的(De)在(Zai)于(Yu)传(Chuan)递(Di)更(Geng)多(Duo)信(Xin)息(Xi),(?)并(Bing)不(Bu)代(Dai)表(Biao)本(Ben)平(Ping)台(Tai)观(Guan)点(Dian)。(?)如(Ru)涉(She)及(Ji)作(Zuo)品(Pin)内(Nei)容(Rong)、(?)版(Ban)权(Quan)和(He)其(Qi)它(Ta)问(Wen)题(Ti),(?)请(Qing)在(Zai)本(Ben)平(Ping)台(Tai)留(Liu)言(Yan),(?)我(Wo)们(Men)将(Jiang)在(Zai)第(Di)一(Yi)时(Shi)间(Jian)处(Chu)理(Li)。(?)
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