国药监发布第28批参比制剂目录,仿制药一致性评价进一步推进
p style=" text-indent: 2em text-align: justify " 近日,国家药监局关于发布仿制药参比制剂目录(第二十八批)的通告(2020年第35号)。目录中包括39种药物(含不同剂型)的参比制剂。这就意味着这些有参比制剂的品类的相关仿制药项目可以启动注册审批。 /p p style=" text-align: justify margin-top: 5px " 因此,从这次批准的参比制剂中可以看出:按照功效作用来看,抗感染类药物所占数量较多,为22%,除去剂量不同的相同品种占25%。 /p p style=" text-align: center margin-top: 15px " img style=" max-width: 100% max-height: 100% width: 584px height: 233px " src=" https://img1.17img.cn/17img/images/202006/uepic/4255b979-a2de-4424-bb21-9a446a9d2302.jpg" title=" 仿制药分布New.png" alt=" 仿制药分布New.png" width=" 584" vspace=" 0" height=" 233" border=" 0" / /p p style=" text-align: center margin-bottom: 25px " span style=" font-size: 14px color: rgb(0, 112, 192) " strong 图为不同功效的药物所占的比例(右侧是合并同种药物不同剂型的统计) /strong /span br/ /p p style=" text-align: justify margin-bottom: 15px " 按照剂型来看,注射剂最多(占41%),其次是片剂(占33%)。 /p p style=" text-align: center margin-bottom: 15px " img style=" max-width: 100% max-height: 100% width: 450px height: 296px " src=" https://img1.17img.cn/17img/images/202006/uepic/58b876f5-07c4-47d4-abb3-ade4d96256af.jpg" title=" 仿制药分布-剂型.png" alt=" 仿制药分布-剂型.png" width=" 450" vspace=" 0" height=" 296" border=" 0" / /p p style=" margin-bottom: 15px text-align: center " span style=" color: rgb(0, 112, 192) font-size: 14px " strong 图为不同剂型所占的比例 /strong /span /p p style=" text-align: justify margin-bottom: 15px " 来自美国的药品占44%,近一半;来自欧洲的有36%,还有两种来自日本的原研药。值得注意的是,已经有14%的药品是已经进口至国内使用的,如日本电工Tulobuterol Patch妥洛特罗贴剂Amiaid(阿米迪)。 /p p style=" text-align: center margin-bottom: 15px " img style=" max-width: 100% max-height: 100% width: 492px height: 305px " src=" https://img1.17img.cn/17img/images/202006/uepic/5823eb80-a73f-4b86-83bd-92a55a0e6cc0.jpg" title=" 仿制药分布-进口类型.png" alt=" 仿制药分布-进口类型.png" width=" 492" vspace=" 0" height=" 305" border=" 0" / /p p style=" margin-bottom: 15px text-align: center " span style=" font-size: 14px color: rgb(0, 112, 192) " strong 图为不同来源药物所占的比例 /strong /span /p p style=" text-align: justify " 仿制药参比制剂是做生物等效性(BE)研究的参照品。为规范仿制药审评和一致性评价工作,优化工作程序,强化服务指导,保证公平、公正、公开,化学仿制药参比制剂需要通过遴选产生。参比制剂遴选应以为公众提供高质量的仿制药品为目标。 /p p style=" text-align: justify margin-top: 20px margin-bottom: 10px " span style=" color: rgb(255, 0, 0) " strong 遴选步骤和遵循的原则如下: /strong /span /p p style=" text-align: justify margin-bottom: 15px " (1)原研药品选择顺序依次为:国内上市的原研药品、经审核确定的国外原研企业在中国境内生产或经技术转移生产的药品、未进口原研药品。原研药品是指境内外首个获准上市,且具有完整和充分的安全性、有效性数据作为上市依据的药品。 /p p style=" text-align: justify margin-bottom: 15px " (2)在原研药品停止生产或因质量等原因所致原研药品不适合作为参比制剂的情况下,可选择在美国、日本或欧盟等管理规范的国家获准上市的国际公认的同种药品、经审核确定的在中国境内生产或经技术转移生产的国际公认的同种药品。国际公认的同种药物是指在美国、日本或欧盟等获准上市并获得参比制剂地位的仿制药。 /p p style=" text-align: justify margin-bottom: 15px " (3)其他经国家药品监督管理局评估确定具有安全性、有效性和质量可控性的药品。 /p p style=" text-align: justify " br/ /p p style=" text-align: justify " span style=" color: rgb(0, 112, 192) " strong 附件:仿制药参比制剂目录(第二十八批) /strong /span /p div br/ /div p style=" text-align: center " img style=" max-width: 100% max-height: 100% width: 560px height: 308px " src=" https://img1.17img.cn/17img/images/202006/uepic/cc99c6e8-6d6f-4bdf-ade2-55d609b9a18e.jpg" title=" 仿制药参比-1N.png" alt=" 仿制药参比-1N.png" width=" 560" vspace=" 0" height=" 308" border=" 0" / /p p style=" text-align: center " & nbsp img style=" max-width: 100% max-height: 100% width: 560px height: 287px " src=" https://img1.17img.cn/17img/images/202006/uepic/6230fb72-adee-4a8c-9e19-a690aab76c9c.jpg" title=" 仿制药参比-2.png" alt=" 仿制药参比-2.png" width=" 560" vspace=" 0" height=" 287" border=" 0" / /p p style=" text-align: center " img style=" max-width: 100% max-height: 100% width: 560px height: 268px " src=" https://img1.17img.cn/17img/images/202006/uepic/e0dc7130-335b-4530-9812-439a260545b9.jpg" title=" 仿制药参比-3.png" alt=" 仿制药参比-3.png" width=" 560" vspace=" 0" height=" 268" border=" 0" / /p p style=" text-align: center " img style=" max-width: 100% max-height: 100% width: 560px height: 270px " src=" https://img1.17img.cn/17img/images/202006/uepic/380fac1b-19c9-4d71-afd9-ce148ab007cc.jpg" title=" 仿制药参比-4.png" alt=" 仿制药参比-4.png" width=" 560" vspace=" 0" height=" 270" border=" 0" / /p p style=" text-align: center " img style=" max-width: 100% max-height: 100% width: 560px height: 273px " src=" https://img1.17img.cn/17img/images/202006/uepic/3cfd1e1d-c1e4-4b8c-a6f2-81981738f6cd.jpg" title=" 仿制药参比-5.png" alt=" 仿制药参比-5.png" width=" 560" vspace=" 0" height=" 273" border=" 0" / /p p style=" text-align: center " img style=" max-width: 100% max-height: 100% width: 560px height: 279px " src=" https://img1.17img.cn/17img/images/202006/uepic/2371997c-6bec-4e44-abf5-5fba0b9db1a9.jpg" title=" 仿制药参比-6.png" alt=" 仿制药参比-6.png" width=" 560" vspace=" 0" height=" 279" border=" 0" / /p p style=" text-align: center " img style=" max-width: 100% max-height: 100% width: 560px height: 287px " src=" https://img1.17img.cn/17img/images/202006/uepic/2dee56e8-c3e3-4dcd-b2c2-dc5a46caea81.jpg" title=" 仿制药参比-7.png" alt=" 仿制药参比-7.png" width=" 560" vspace=" 0" height=" 287" border=" 0" / /p p style=" text-align: center " img style=" max-width: 100% max-height: 100% width: 560px height: 283px " src=" https://img1.17img.cn/17img/images/202006/uepic/c6e1774a-7c0c-4216-90bc-4545a2ac65e1.jpg" title=" 仿制药参比-8.png" alt=" 仿制药参比-8.png" width=" 560" vspace=" 0" height=" 283" border=" 0" / /p p style=" text-align: center " img style=" max-width: 100% max-height: 100% width: 560px height: 133px " src=" https://img1.17img.cn/17img/images/202006/uepic/0f310e5e-e64d-4a46-a23e-ec00f616367f.jpg" title=" 仿制药参比-9.png" alt=" 仿制药参比-9.png" width=" 560" vspace=" 0" height=" 133" border=" 0" / /p p style=" text-align: center margin-bottom: 5px " img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202006/uepic/d60d2a06-420e-49e0-a3be-4d9fb31a664f.jpg" title=" 分割线.png" alt=" 分割线.png" / /p p style=" text-align: center margin-top: 15px margin-bottom: 20px " span style=" font-size: 20px " strong span style=" background-color: rgb(255, 192, 0) color: rgb(0, 112, 192) " 一致性评价——药典仪器必备 span style=" font-size: 20px color: rgb(0, 112, 192) background-color: rgb(255, 255, 255) " 【点击图片即可进入相关文章】 /span /span /strong /span br/ /p p style=" text-align: center" a href=" https://www.instrument.com.cn/news/20200413/535932.shtml" target=" _blank" img style=" width: 423px height: 145px " src=" https://img1.17img.cn/17img/images/202006/uepic/633a5d22-6281-4e44-b09b-207e48e882c0.jpg" title=" 1.jpg" alt=" 1.jpg" width=" 423" vspace=" 0" height=" 145" border=" 0" / /a /p p style=" text-align: center" a href=" https://www.instrument.com.cn/news/20200420/536433.shtml" target=" _blank" img style=" max-width: 100% max-height: 100% width: 423px height: 152px " src=" https://img1.17img.cn/17img/images/202006/uepic/be42bceb-8476-4d4e-abe4-44795a07e4f2.jpg" title=" 2.jpg" alt=" 2.jpg" width=" 423" vspace=" 0" height=" 152" border=" 0" / /a /p p style=" text-align: center" a href=" https://www.instrument.com.cn/news/20200428/537308.shtml" target=" _blank" img style=" width: 423px height: 154px " 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