CHMP已采纳ICH Q3元素杂质，16年执行

一沙一叶

在最终的ICH指南公布后，第五步就是ICH的3个地区分别将其纳入各自的国家法规体系中。“ICH的元素杂质指南-Q3D”第四步文件是2014.12.19日公布的。四周后-2015.01.12-在CHMP通过一个正式的法案采纳这个指南后，这个指南正式纳入了EMA的“科学指南”系列。从此以后，ICH的页面就能轻易的招到了ICH Q3D了。
指南的关于文件历史的表格中包含了对于制药和API行业的重要信息，说明了强制执行ICH Q3D的要求。
到2016.06新的市场许可要应用Q3D的要求；
到2017.12已批准的医药产品要应用该要求。
还有不到三年的时间，已获得批准的或者已经上市的医药产品都要按照Q3D的要求实现元素杂质/每日可接受剂量的限度控制。
After the publication of a final ICH guideline, its implementation into the respective national regulations of the 3 ICH regions Europe, USA and Japan (Step 5 of the ICH process) is usually the next step. The "ICH Guideline for elemental impurities - Q3D" was published on 19 December 2014 as Step 4 document. Four weeks later - on 12 January 2015 - the integration of the Guideline into EMA's set of rules of "Scientific Guidelines" was notified after the CHMP committee had adopted it through a formal act. As for all the ICH guidelines which are integrated into the collection of "Scientific Guidelines", the corresponding EMA Guideline which is now entitled "ICH guideline Q3D on elemental impurities" is composed of only one table of the document history and the section "scope" identical to that of the original ICH guideline. After that, there is just a direct link to the ICH page containing the "Quality Guidelines" where the Q3D can be easily found. The table with the document history contains important information for the pharmaceutical and API industry of the EU member states about the coming into force of the ICH Q3D requirements. These regulations will be binding: As of June 2016 for new marketing authorisation applications and As of December 2017 for authorised medicinal products The time window for the verification of authorised and/ or already marketed medicinal products for compliance with the limits regarding elemental impurities/ acceptable daily doses is now only 3 years.

玻璃杯

API也要求？
这个太困难了吧？

xhf123456

如果API也按此规定有点难

syhorchid

吐槽