辅助药品（AMP）新定义

20160614 ECA新闻：辅助药品（AMP）新定义

GMP News
14/06/2016

New Definition for Auxiliary Medicinal Products (AMPs)

辅助药品（AMP）新定义

The EU Commission has launched four public consultations on recommendations related to clinical trials:

EU委员会发起了4个征求公众意见的临床试验相关文件：

• Public consultation on "Risk proportionate approaches in clinical trials"
• 公众对“临床试验中风险比例方法”的意见
• Public consultation on "Summary of Clinical Trial Results for Laypersons"
• 公众对“临床试验结果给外行人的摘要”的意见
• Public consultation on the revision of the "Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)" (previously called "Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs))
• 公众对“研究用药品定义（IMP）和辅助药品使用（AMP）”（之前称为“研究用药品（MP）和非临床前药品（NIMP）指南”）修订的意见
• Public consultation on the revision of "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors"
• 公众对“对少数人进行的药物临床试验道德方面考虑”修订的意见
  
  

The public consultations are open from 1 June 2016 to 31 August 2016.

公开征求意见自2016年6月1日起至2016年8月31日止。

The eight page consultation document "Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)" intends to "clarify and provide additional guidance on the definition of IMPs and to provide recommendations about the use of auxiliary medicinal products (AMPs)".

8页的征求意见文件题为“研究用药品（IMP）定义和辅助药品（AMP）使用”，其意在“澄清和提供额外指南，定义IMP，并提供关于使用辅助药物（AMP）的建议”。

It is outlined that medicinal products with a marketing authorisation are also considered to be IMPs, "when they are to be used as the test product, reference product or placebo in a clinical trial." But what are AMPs? So far, Regulation (EU) No 536/2014 Article 2 (8) defines an AMP as "a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product". These could be, for example:

其中列出了同样被认为是IMP的具有上市许可的药物，“当它们在临床试验中被用作测试药物，对照药品或空白安慰剂时”。但什么是AMP？截止目前，欧盟指令EU NO536/2014第2（8）

• Rescue medication 援救药物
• Challenge agents 挑战试剂
• Medicinal products used to assess end-points in the clinical trial 临床试验用于评估终点的药物
• Medicinal products used for background treatment 背景治疗所用药物
  
  

This means that AMPs are medicinal products. But not all products used in clinical trials are medicinal products (for example certain challenge agents). As a consequence these products are not AMPs. A list of types of AMPs, with examples, is included in Annex 1 of the respective document.

这意味着AMP是药物。但并不是所有用于临床试验的产品都是药品（例如特定的挑战试剂）。因而这些产品并不是AMP。此类AMP的清单，还有举例都放在相应文件的附录1中。

Furthermore the document discusses the use of authorised AMPs and unauthorised AMPs and further requirements like documentation and adverse reactions.

另外，文件讨论了使用经过许可的AMP和未经许可的AMP，以及象文件记录和不良反应的更多要求。

来源：http://zhuyujiao1972.blog.163.co ... 272016515101738769/