Txhawm rau ua raws li "Kev xav ntawm Lub Chaw Haujlwm Saib Xyuas Kev Lag Luam ntawm Lub Xeev ntawm Kev Sib Tham Sib Tham Sib Tham Txog Kev Saib Xyuas Kev Hloov Kho Tshuaj thiab Cov Khoom Siv Khomob los txhawb qhov siab-Kev Txhim Kho Zoo ntawm Kev Lag Luam Pharmaceutical" (Guobanfa 〔2024〕 Tsis yog. 53), txhim kho qhov zoo ntawm cov tshuaj generic txhim kho cov khoom siv tshuaj zoo, cov ntaub ntawv siv tshuaj generic, (CDE), raws li kev xyaum ntawm kev tshuaj ntsuam xyuas kev ua haujlwm, tau teeb tsa qhov kev tsim qauv ntawm "Cov Kev Xav Tau rau Kev Sau Cov Qauv 2 Cov Ntaub Ntawv Tshuaj Hauv Kev Tso Cai Ua Lag Luam Cov Ntawv Thov rau Cov Tshuaj Siv Tshuaj Siv Tshuaj (Cov Khoom Siv Tshuaj Siv Hluav Taws Xob) (Tshooj Sib Tham)" thiab "Kev Xav Tau rau Compiling Module 2 Pharmaceutical Daim Ntawv Thov Kev Lag Luam Hauv Cov Ntawv Tso Cai Siv Tshuaj. (Kev Npaj) (Tshwj Xeeb Version)" (tom qab no hu ua "Compilation Requirements", saib Annexes 1 thiab 2). Raws li kev tshuaj xyuas thiab kev pom zoo los ntawm National Medical Products Administration (NMPA), cov ntaub ntawv tau muab tawm ntawm no, thiab cov kev xav tau ntawm kev ua raws li hauv qab no:
Cov peev txheej ntawm daim ntawv thov ntawm Cov Lus Cog Tseg no suav nrog kev tso cai ua lag luam rau cov tshuaj siv tshuaj (xws li Tshuaj Kho Mob Qib 3, Qib 4, Qib 5.2, thiab cov khoom xyaw tshuaj nquag).
Cov Kev Cai Sau Cov Cai no yuav tsum tau pib siv rau lub Peb Hlis 1, 2026. Ua ntej hnub siv, cov neeg thov siv tshuaj siv tau raug txhawb kom xa cov ntaub ntawv thov raws li Cov Kev Cai Sau Cov Cai no txij li hnub tau tshaj tawm tsab ntawv tshaj tawm no.
Tsis pub dhau 10 hnub tom qab tau txais cov tshuaj siv ntau yam, tus neeg thov yuav tsum xa cov ntaub ntawv tshuaj Module 2 hauv Lo Lus los ntawm "Cov Khoom Siv Tshuaj Summary" ntawm "Applicant Window", thiab ib txhij xa cov lus sib xws rau cov ntaub ntawv thov hauv Lo Lus thiab PDF hom ntawv.
