EMA---减少使用动物试验的活动

EMA - Activities to reduce the Use of Animal Testing

EMA---减少使用动物试验的活动

In some cases - e.g. the classical pyrogen testing, the so called "rabbit test" - animal tests have been traditionally used. In accordance with the Directive 2010/63/EU on the protection of animals used for scientific purposes (from 3 June 2010) and in line with other associated relevant guidelines, the EMA as well as the member states of the European Union try to replace animal tests by new methods. They follow the principle of the 3Rs (Replacement, Reduction and Refinement) selecting approaches for validating quality control tests in laboratories for regulatory testing of human and veterinary medicinal products.

有些情况下，例如，传统的热源测试，会使用所谓的“兔子试验”。根据指令2010/63/EU关于保护科学用动物的法规（自2010的6月3日起），以及其它相关指南，EMA及欧盟成员国尝试使用新方法替代动物试验。他们遵守3R（替代、减少和精炼）选择方法原则来验证人药和兽药法规测试化验室质量控制试验。

Now the EMA published a Draft "Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs" for public consultation until 31 January 2017. This guidance aims to facilitate transfer of the new methods validated in such trials with a view to implementing 3Rs for testing in a product specific context in laboratories originally involved in the collaborative trial or in new laboratories. The document should be helpful in supporting regulatory applications for variations to existing marketing authorisations as well as new applications.

现在EMA公布了一份“鉴于3R在相关试验中实施的验证过的质量控制方法转移单个化验室指南”草案公开征求意见，截止日期为2017年1月31日。该指南目的是为新化验室或之前参与协作 试验的化验室产品特定环境中检测推进实施3R，帮助经过此类试验验证的新方法的转移。文件应有助于支持对现在上市许可变更的法规申报以及新申报。

The draft document includes the following items: 指南草案包括以下荐项目：

1. Introduction (background 前言（背景）
2. Scope 范围
3. Legal basis 法规依据
4. General features of a collaborative study and its role in method validation 协作研究的一般特点及其在方法验证中的作用
5. Validation of 3Rs methods for regulatory acceptance 法规可接受的3R方法验证
6. Transferring collaborative study validated methods to specific products/laboratories References 转移协作研究中验证过的方法至指定产品/化验室参照

The activities to reduce animal testing are shown in other documents too. One example is the implementation of alternative test method in the European Pharmacopoeia (Ph. Eur.) - EDQM announces revision of general chapter Monocyte Activation Test (2.6.30) .

减少使用动物试验的活动也在其它文件里有体现。例如EP中替代检测方法的实施。

To get more detailed information or for commenting, please also see the "Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs".

关于征求意见的详细信息参见上述官网指南。