2）Medicine type药品类型搜索，包括：Accelerated assessment加速审评（可查询共112个药品的加速审评情况）、Additional monitoring附加监测（共766个药品需要完善相关信息）、Biosimilar生物仿制药（共101个药品）、Conditional approval有条件批准（共125种药品）、Exceptional circumstances特殊情况、Generic仿制药（共355中药品...
Where possible,the text within each theme provides an explanation of what the variousresponsibilities may mean at a practical level for MAHs; guidance is also givenon what is expected of an MAH when fulfilling that responsibility. It should benoted, however, that this Reflection Paper does not ...
Where possible,the text within each theme provides an explanation of what the variousresponsibilities may mean at a practical level for MAHs; guidance is also givenon what is expected of an MAH when fulfilling that responsibility. It should benoted, however, that this Reflection Paper does not ...
第四部分:Post-authorisation许可后管理,欧洲药品管理局(EMA)为其医药产品已在欧洲获得许可的制药公司提供相关管理的科学及法规指南。包括:1)Availability of medicines药品供应,介绍欧盟层面对供应中断问题的协调2)Certifying medicinal products产品证书,包括电子证书、电子证书真实性验证、证书收费、电子证书指南等3)Changin...
7)Contacting EMA: post-authorisation与EMA联系:许可后 8)Data on medicines (ISO IDMP standards)要求上市授权人及时递交最新的产品信息 9)Improving quality of submissions 提高提交材料的质量 10)Notifying a change of marketing status上市状况及撤市
post-approval change management, via ICH Q12,related to medicinal products for human use. Such flexibility is likely to relyon the effectiveness of the pharmaceutical quality system that is in place, asthis will help assure regulatory compliance in the implementat...
For additional guidance on changes to existing presentation that cantrigger new EU number(s) please see theEMA post-authorisation guidance for Type IA, Type IB and Type II variations. 可能会激活新EU编号的现有形式变更更多指南参见上述网址。
The quality guidance applies to new marketing authorisation applications and post approval changes.The equivalence guidance is applicable to certain cases of demonstration of equivalence of a new topical medicinal product with an existing medicinal product.质量指南适用于新的上市许可申请和批准后变更。 等效...
For additional guidance on changes to existing presentation that cantrigger new EU number(s) please see the EMA post-authorisation guidance for Type IA, Type IB and Type II variations. 可能会激活新EU编号的现有形式变更更多指南参见上述网址。 2.7. How should I submit a new working cell bank(WCB...
Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval. (ICH Q8) 被证明会给产品质量提供保证的输入变量(例如,物料属性)的...