我的疑虑(工作邮件,所以是英文):
Ø Definition about “原辅料”. The description in “适用范围” is quite confusing: “目前将本《规定》适用范围确定为原料药、中药提取物、辅料、直接接触药品的包装材料和容器。同时本规定仅限于用于药品制剂注册和已批准生产的药品制剂所使用的原辅材料的备案。” So, does “原辅料” include raw materials and excipients for packaging material and containers that contact with drugs immediately? Do they also need to be audited by finished product manufacturers according to item 9?
Ø Item 12: “用于已批准上市药品制剂的原辅材料,可以在规定的时间内进行备案,备案时应提供使用该原辅材料的制剂情况。” What’s the timeline?
Ø Item 16: Different suppliers may have different criteria on whether the influence on the quality of “原辅料” brought by its manufacturing is major or minor. Is there a uniform criteria (such like SFDA guidance on CMC variation)?
Ø Item 18: What’s the procedure if a manufacturing variation of “原辅料” happens during the technical review in the registration application of a finished drug product? (I asked this question because such variation will delay the approval of finished products after the implementation of this regulation.)
Ø Others: What about intermediates? What information will be in the open part and what will be in the un-open part?