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[热点] Materials Today Chemistry审稿周期 影66 2026-01-17 刚刚
[注册申报] [已完结]求助民族药物申报的问题 (2/289) yiuli1984 2014-08-20 2014-08-20 20:39:58 by fbifbeaifb
[注册申报] [已完结]请教中药六类新药报产的13#资料的撰写 (0/215) ld0371 2014-08-20 2014-08-20 11:17:31 by ld0371
[注册申报] CDE8月19日承办总结一览 (14/1228) weakup 2014-08-20 2014-08-20 09:24:28 by xuxiuling
[注册申报] [已完结]求助说明书 (4/574) xionghuan 2014-08-12 2014-08-19 17:26:54 by quitear
[注册申报] [已完结]已知FEI number(FDA Establishment Registration number),如何查找相关信息? (0/5854) beenomics 2014-08-19 2014-08-19 15:09:19 by beenomics
[注册申报] [已完结]想做一种尿素C13的诊断试剂,但是中检所没有标准品,只有普通尿素的,该怎么办呢? (2/707) yinss 2014-08-18 2014-08-18 10:57:36 by yinss
[注册申报] [已完结]求药事管理学,药学专业英语 课件 (2/1012) dha88 2014-08-01 2014-08-17 14:34:31 by J1205
[注册申报] 2014年8月13日CDE受理药品总结 (8/1297) weakup 2014-08-14 2014-08-14 13:53:09 by markyu2012
[注册申报] 单剂量与多剂量的问题 (5/2875) wcwno1 2014-08-06 2014-08-14 08:30:29 by wcwno1
[注册申报] [已完结]为什么生物仿制药比化学仿制药难报批? (9/1877) zhengaq 2014-08-10 2014-08-13 11:06:28 by senw
[注册申报] 2014年8月12日CDE受理药品总结 (14/1512) weakup 2014-08-13 2014-08-13 10:49:44 by mzhyan
[注册申报] 置信区间探讨 (6/2058) 静默wang 2014-08-08 2014-08-11 21:41:25 by 静默wang
[注册申报] [已完结]关于药物晶型的研究 (6/1976) nanbu7989 2012-11-30 2014-08-11 11:51:59 by 打开你的心扉
[注册申报] CDE2014年8月7日受理总结 (6/2918) weakup 2014-08-09 2014-08-10 08:44:55 by 凌宇雷池
[注册申报] [已完结]生物制品注册申报资料 (7/1656) yiluhuakai 2014-07-23 2014-08-08 10:51:36 by yuepeng7
[注册申报] CDE-2014年8月5日受理药品总结 (评阅+2) (12/1293) weakup 2014-08-07 2014-08-07 12:49:51 by zdp840130
[注册申报] [已完结]请教进口注册申报标准问题-可以直接用国外药典标准申报吗 (9/1878) Abbytan 2014-08-01 2014-08-07 09:16:36 by Abbytan
[注册申报] 如何提前与审评中心的人员取得沟通? (9/1284) zxb1980083 2014-08-06 2014-08-07 06:33:48 by l-c-l
[注册申报] [已完结]3.1类化药的药品名称来源 (7/1456) huifang.ma 2014-08-01 2014-08-04 16:13:23 by xiongluimm
[注册申报] 【讨论】地氯雷他定片 (7/1175) ccmaodou 2010-06-11 2014-08-02 04:20:15 by liukarl
[注册申报] [已完结]请问几个药理毒理综述撰写的问题 (2/480) 孙小毛 2014-07-31 2014-08-01 15:03:58 by mikeail
[注册申报] [已完结]Approval Application of Pharmaceuticals" (PFSB Notification No. 0331015) (1/889) 翡凡8316 2014-07-29 2014-07-30 10:48:47 by lkghlkdgh
[注册申报] 找不到毒理资料 (7/769) xiaowanzi9 2014-07-25 2014-07-28 20:20:00 by xiaowanzi9
[注册申报] [已完结][关贴]撰写说明书的困境... (3/610) liangzhu99 2014-07-25 2014-07-25 12:56:07 by 星海慧儿
[注册申报] [已完结]请教一下各位虫友 这种药应该按几类药申报啊? (7/1392) mengdragon 2014-07-15 2014-07-25 10:20:37 by langerdorff
[注册申报] 国家局动态,上传认证中心的电子资料,可以简化呢 (2/360) liwenyue1978 2014-07-24 2014-07-24 15:34:53 by kbxfksi
[注册申报] [已完结][关贴]请问当自身对照为0.1%时,调节检测灵敏度,使主成分色谱峰高约为满量程的多少算合适 (4/1286) 冷雨孤风 2014-07-23 2014-07-24 15:23:32 by kbxfksi
[注册申报] [已完结]请教SFDA中“已发批件”解读,到底是已获批件还是退审?上哪查?    ( 1 2 3 ) (24/5585) tuqingbo 2014-07-19 2014-07-24 14:36:45 by mengdragon
[注册申报] [已完结]印度Dr. Reddy's Laboratories生产“多潘立酮”原料药供货商的联系方式。 (2/978) webmaster669 2014-07-21 2014-07-22 09:18:41 by werohthtw
[注册申报] [已完结]药品命名 (5/789) zs198654 2014-07-18 2014-07-22 07:31:58 by fxzxp
[注册申报] 谁知道有没有专门写药理毒理资料的机构啊 (3/453) wangxuyan 2014-04-24 2014-07-19 20:14:44 by wuzhongyuan21
[注册申报] [已完结]关于药品的补充申请 (8/2470) mengdragon 2012-07-11 2014-07-19 07:23:16 by roweahioh
[注册申报] 想请教一下,安瓿瓶上的色环是什么意思? (6/3525) jinger8017 2014-07-15 2014-07-18 13:24:24 by njutcm_shen
[注册申报] [已完结]溶剂峰问题 (9/1194) yellowmaple 2013-04-12 2014-07-16 05:56:26 by 莱仕德
[注册申报] 只做一步游离精制,申报4类原料药有没有问题?    ( 1 2 ) (11/1625) 酔欲陶然 2014-07-11 2014-07-15 14:54:44 by tony.shcn
[注册申报] [已完结]求助下面三个化合物的合成路线 (3/690) yazhou 2014-07-12 2014-07-14 10:08:36 by roweahioh
[注册申报] [已完结]单成分注射剂CTD资料处方筛选怎么写,原料+注射水仿制药 (2/1151) anshicai 2014-07-12 2014-07-14 10:04:00 by roweahioh
[注册申报] [已完结]中文CTD有没有字体格式要求?    ( 1 2 ) (DRDEPI+1)(12/3726) huangq816 2011-06-10 2014-07-14 07:29:35 by luyuehan
[注册申报] [已完结]药物稳定性研究是参照旧版药典,新的标准出来后需要重新来一遍吗?    ( 1 2 ) (19/1944) lanjing87802 2014-07-10 2014-07-13 04:53:48 by summers1985
[注册申报] [已完结]制剂申报时可以同时报两家原料药供应商吗? (5/2656) 光棍花园 2014-06-10 2014-07-12 11:17:09 by roweahioh
[注册申报] 薄膜包衣片中药注册申报需要做溶出度实验考察吗?    ( 1 2 ) (10/1553) 03yx2 2014-07-09 2014-07-11 15:53:44 by 星海慧儿
[注册申报] [已完结]请问3+6类原料药是否按3类申报 (7/2183) dennylvny 2014-07-10 2014-07-11 10:04:26 by roweahioh
[注册申报] [已完结]化药3+6的注册申报及现场核查 (8/2869) cuigang7979 2013-07-27 2014-07-11 05:16:17 by kdl0721
[注册申报] [已完结]原料药资质 (2/601) chennwu 2014-07-10 2014-07-10 17:25:10 by voyager88
[注册申报] [已完结]药品注册材料补正后怎么在药监局网站提交 (6/1399) lanjing87802 2014-07-09 2014-07-10 11:13:43 by lanjing87802
[注册申报] [已完结]关于申报新饲料添加剂的问题 (1/703) 975316031 2014-07-07 2014-07-08 09:30:31 by weothw
[注册申报] [已完结]求助2012年国内申报的所有1类新药(化药) (5/1291) nangehenha 2013-11-03 2014-07-08 08:42:42 by rippless
[注册申报] 2014.5.13CFDA--药物安全药理学研究技术指导原则等8项技术指导原则 (1/552) lwjxz 2014-07-06 2014-07-07 09:58:54 by orehoge
[注册申报] [已完结]求:他克莫司及其制剂的USP33标准 (8/2284) lizzieyw77 2012-01-31 2014-07-05 18:21:16 by ggxt11
[注册申报] [已完结]辅料注册申报问题,求助~ (1/611) 卖萌的小馒头 2014-04-17 2014-07-05 12:15:53 by lcy507283137
[注册申报] [已完结]方法学验证哪个项目先做?    ( 1 2 ) (10/3484) fangkan0411 2013-10-22 2014-07-05 06:47:24 by gwmgyp
[注册申报] [已完结]国外上市药国内未上市改适应症改剂型算几类药    ( 1 2 ) (12/2029) pepfsl 2014-07-03 2014-07-04 11:32:29 by lk590
[注册申报] [已完结]哪位大侠可以解释一下这些分类的中文意思吗 (1/307) ychuanwei 2014-07-03 2014-07-03 23:12:17 by wangyc3
[注册申报] [已完结]一次性预装注射笔和注射液申报 (3/781) JXY_19851019 2014-07-02 2014-07-03 10:05:35 by JXY_19851019
[注册申报] [已完结]求购进口标准的途径或者方法 (4/621) venus2008 2014-07-01 2014-07-02 15:06:11 by 卢小山
[注册申报] [已完结]Ingenol mebutate (1/446) sz280115710 2014-07-01 2014-07-02 14:13:14 by roweahioh
[注册申报] CDE哈尔滨培训录音(原料部分)    ( 1 2 ) (15/2601) ltxin2009 2014-06-25 2014-07-02 08:34:05 by totoyoyo1997
[注册申报] [已完结]辅料变更如何重新申报? (3/833) folger 2014-06-26 2014-06-30 09:34:25 by qwoiyhroiw
[注册申报] [已完结][关贴]求药审中心哈尔滨培训课件 (1/386) gwmgyp 2014-06-28 2014-06-28 09:13:19 by gwmgyp
[注册申报] [已完结]新药注册中查新报告的疑问? (5/1102) haichang 2014-06-23 2014-06-26 10:32:04 by qwoiyhroiw
[注册申报] 【求助】谁了解韩国的注册法规? (4/1125) ghcmcc03 2010-06-28 2014-06-24 06:56:43 by eroitoei
[注册申报] 同一厂家相同剂型和给药途径的药物为什么有两个不同的申请号?    ( 1 2 ) (10/2488) 爱水如蓝117 2014-06-18 2014-06-23 09:51:32 by 爱水如蓝117
[注册申报] 【求助】新药申报,到什么阶段需要上会?什么叫三合一?    ( 1 2 ) (10/4471) guava1982 2010-11-19 2014-06-22 21:41:06 by 1舒心
[注册申报] [已完结]林可酰胺类抗生素能在普通车间进行生产吗? (2/772) zhuzhuwan 2014-06-19 2014-06-21 21:26:10 by News
[注册申报] [已完结]六类注射剂申报如何免临床选择生物等效性,特殊剂型也一样吗 (5/2106) anshicai 2014-06-19 2014-06-21 09:53:51 by gwmgyp
[注册申报] 依达拉奉 双鹤 3.1类申报    ( 1 2 ) (11/3019) einorain 2011-05-03 2014-06-21 08:47:52 by lijinzhi
[注册申报] [已完结]求助药品注册方面问题    ( 1 2 ) (10/1858) zzq1301402 2011-12-05 2014-06-18 19:07:22 by blue_sky2014
[注册申报] 有做中药新药研发的吗?中药复方制剂很不被看好吗?被批准的概率大吗?    ( 1 2 ) (14/2732) sunli0314 2014-06-13 2014-06-18 10:22:35 by 暄其1712
[注册申报] [已完结]增加药品的规格,需要和原研产品进行比较吗? (5/1402) emaoxue 2014-04-09 2014-06-18 10:05:29 by gwmgyp
[注册申报] [已完结]中成药复方制剂申报 (0/994) jimih 2014-06-17 2014-06-17 16:00:06 by jimih
[注册申报] [已完结]化药1.6类报临床,申报材料可以用CTD格式吗? (6/1657) jxnccsq 2014-06-10 2014-06-15 19:04:34 by jxnccsq
[注册申报] [已完结]放宽药品储存条件,变更申请包含的内容 (6/1391) Lensly 2014-06-11 2014-06-13 09:53:52 by eroitoei
[注册申报] [已完结]第三类医疗器械临床前药理毒理研究具体都做哪些项目 (2/1039) huige863 2013-06-20 2014-06-13 07:39:34 by eroitoei
[注册申报] [已完结]怎么向国家局补寄资料 (9/1317) GARENTTXX 2014-06-09 2014-06-12 12:16:58 by GARENTTXX
[注册申报] [已完结]请教,这个药如何避开专利?    ( 1 2 ) (12/2638) 252828 2013-10-19 2014-06-11 12:38:52 by f1yfish
[注册申报] 关于CTD格式撰写注册3类药品申报资料的探讨    ( 1 2 ) (12/3521) shhtzyc 2014-05-30 2014-06-11 09:22:55 by shhtzyc
[注册申报] [已完结]求助-盐酸文拉法辛缓释胶囊说明书 (9/1193) qlq10 2014-05-23 2014-06-10 16:29:12 by ffffzmj
[注册申报] [已完结]EMA中塞来昔布的审评报告 (2/1085) liupan 2014-06-09 2014-06-10 12:02:11 by fengzi913
[注册申报] 增加适应症提申请的话,应属于新药申请吗?    ( 1 2 ) (12/2827) 许多多爱自己 2014-06-04 2014-06-09 15:53:13 by 许多多爱自己
[注册申报] 注射剂灌装量和规格申报规格问题    ( 1 2 3 4 ) (30/3526) zhaojia6629 2014-06-05 2014-06-09 09:14:03 by 无双国士
[注册申报] [已完结]在线急求-两个国外进口商,如何确定哪个是原研药厂家 (9/1967) 许多多爱自己 2014-04-12 2014-06-07 16:50:47 by liliaceaeren
[注册申报] [已完结]中药5类新药,现申报生产批文需变更提取工艺,想保留原临床批文 (6/1369) 老宋好好 2014-05-13 2014-06-07 11:35:09 by szq215216
[注册申报] [已完结]注册申报求助! (6/1219) kuanga111 2011-07-25 2014-06-07 08:03:43 by qinfangqing
[注册申报] 原料药研发技术要求及申报资料常见问题分析 (评阅-3) (5/1640) panzc2010 2014-06-06 2014-06-06 21:22:15 by lyy220409
[注册申报] [已完结]关于现场考核 (5/957) piracetam 2014-06-04 2014-06-05 20:00:10 by dhzcpu
[注册申报] [已完结]请问豪森的奥氮平片批的是几类? (3/803) awen2004 2014-05-30 2014-06-03 11:47:57 by LuciferZero
[注册申报] 如何衡量国内研发企业的优劣势? (4/1129) 南京华威 2014-05-30 2014-06-03 09:59:48 by eroitoei
[注册申报] 关于药品注册分类的疑问    ( 1 2 ) (16/2853) hbsjz.lulu 2011-11-30 2014-05-28 07:06:32 by rainbownmuch
[注册申报] [已完结]DMF中有关结构解析的指导原则有哪些 (0/287) 盛岚2013 2014-05-26 2014-05-26 10:37:56 by 盛岚2013
[注册申报] [已完结]原料药申报问题 (9/2811) ypzc0818 2014-05-21 2014-05-23 09:26:36 by dingjinglvde
[注册申报] 溶出度方法验证中重复性和中间精密度怎么做更合理? (19/6827) ltxin2009 2013-01-08 2014-05-20 14:21:22 by zqxia2009
[注册申报] [已完结]FDA 原料药仿制药注册申报的最新流程 (0/1644) qiangang8281 2014-05-19 2014-05-19 15:40:14 by qiangang8281
[注册申报] [已完结]聚谷氨酸申报新兽药,可以吗? (5/871) 975316031 2014-05-12 2014-05-16 11:09:06 by eroitoei
[注册申报] [已完结]求助3类药。17-25号资料 怎么写 (3/551) chuan88 2014-05-13 2014-05-14 16:24:08 by chuan88
[注册申报] [已完结]中成药剂型的市场调研 (2/377) 0509436 2014-05-08 2014-05-09 15:25:40 by 0509436
[注册申报] 使用了剧毒品硫酸二甲酯,申报有难度吗 (6/2123) x9v85 2011-12-12 2014-05-09 10:58:28 by gwmgyp
[注册申报] 从CDE <2012年度中国药品审评报告>看药品研发 (评阅+1) (3/1318) 小狼851226 2013-03-28 2014-05-09 10:41:03 by eroitoei
资源 [ 查看全部 ] 作者 最后发表
[注册申报] 【转帖】新法规下化学药品研发注册中需关注的几个问题    ( 1 2 ) (76/4021) binxman 2011-02-28 2014-06-23 13:16:43 by 吴雷wulei
[注册申报] 2013.10.30(拜耳)魏春芳—中国与全球注册战略发展 (46/1686) lwjxz 2014-05-05 2014-05-25 21:16:17 by qq1860
[注册申报] 【转帖】新药研究趋势与审评动态 (8/1059) honghong33 2011-01-18 2014-05-19 12:11:58 by 东北东北
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