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 ...
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)、Orphan...
laid down in the process deion. In the event that any changes are required to the registered process parameters as a result of full scale process validation studies, these changes should be applied for via post approval variation, in accordance with the variation Regulation (ref. 5, ref. 6)...
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 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...
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。
In the event that any changes are required to the registered process parameters as a result of full scale process validation studies, these changes should be applied for via post approval variation, in accordance with the variation Regulation (ref. 5, ref. 6). 大生产批量的生产工艺验证在产品...
57 2. Scope 58 The purpose of this Note for Guidance is to set out the type of information required for the 59 manufacture and control of active substances (existing or new chemical entities) used in a medicinal 60 product. The differences in requirements for new or existing active ...