【讨论】杂质元素 --ICH Q3D进展

zhulikou431

Q3D EWG：导则杂质元素
报告员报告，在5月31日在明尼阿波利斯举行的Q3D专家工作组会议的结果对SC - 2014年6月5日和进展到达第4步进行。
常设委员会注意到了专家工作组开展的工作，以解决在谘询期内（步骤3）截至12月31日收到的公众意见，2013年该委还指出，在明尼阿波利斯市由专家工作小组的进度，完成专着的检讨所有元素（修订一些允许每日曝光二酯酶（PDE）和USP/ ICH偏微分方程对齐），开发过程中建立了偏微分方程给予额外的途径，并就比偏微分方程建立更高层次的理由提供指导。
常设委员会注意到，该专家工作组将继续通过电话来一起讨论一些执行方面的挑战剩余：该指南的统一的执行和解释（比如，它的应用对现有产品的销售;其一贯的药典和法规遵从）和大容量肠道。该小组还建议开发一些案例研究和培训材料，以帮助促进Q3D方针的理解和执行的非物质文化遗产过程的步骤5。
可以预料，在Q3D准则将达到步骤4由2014年9月的末尾。
SC决策/行动：
标准委支持Q3D专家工作组的工作计划，活动进行到2014年九月底到达第4步;
该专家工作组将取得的进展，在秋天的SC webconference报告以及他们是否会要求成立一个工作小组的****** CE的面对面会议，以完成培训教材。
Q3D EWG: Guideline for Elemental Impurities
The Rapporteur reported to the SC on the outcome of the Q3D EWG meeting held in Minneapolis on 31 May – 5 June, 2014 and progress made towards reaching Step 4.
The SC noted the work undertaken by the EWG to address public comments received during the consultation period (Step3) which ended on 31 December, 2013. The SC also noted the progress made by the EWG in Minneapolis to complete the review of monographs for all elements (revision of some Permitted Daily Exposures (PDEs) and alignment of USP/ICH PDEs), to develop a process to establish a PDE for additional routes of administration and to provide guidance on justification of levels higher than the established PDEs.
The SC noted that the EWG would continue to work by teleconference to discuss a few implementation challenges remaining on: the harmonised implementation and interpretation of the Guideline (e.g., its application to existing marketed products; its consistent compendial and regulatory compliance) and on large volume parenterals. The group also suggested developing some case studies and training materials to help facilitate the understanding and implementation of the Q3D Guideline at Step 5 of the ICH process.
It is expected that the Q3D Guideline will reach Step 4 by the end of September 2014.
SC Decisions/Actions:
 The SC supported the work plan of the Q3D EWG for activity to be undertaken to reach Step 4 by the end of September 2014;
 The EWG will report on progress achieved at the autumn SC webconference and whether they would request the establishment of an IWG an******ce-to-face meeting to finalise a training package.

zhulikou431

M7 EWG：评估与控制的DNA反应的（突变）的药品杂质限制潜在的致癌危险
该报告员报告对2在明尼阿波利斯举行的M7专家工作组会议的结果对SC - 2014年6月5日。
常设委员会注意到，在专家工作组就从区域协商收到的所有公众意见的处理协议。监管M7专家签署过的第4步M7的指引。该资深大律师指出，实施非物质文化遗产M7被鼓励但由于指引的复杂公布后，;应用M7的ICH出版物之前18个月后没有预期。一旦修订发布和要求，公司将不再需要回去和已经在先前的预期测试测试1）销售产品及2）产品在P2B/ P3。常设委员会注意到，该专家工作组将继续审议和讨论提出增编ICH M7其中将包括已知的诱变性杂质及配套专着的可接受的范围。该小组将努力在增编了电话会议，并期望达到第2步在之后的附录草案将在非物质文化遗产的过程中步骤3将提交公众评论2014年12月。
SC决策/行动：
标准委支持了M7的指引建议的实施计划;
对SC签署过的M7导则第4步的监管人员;
在ICH秘书处将举办网络研讨会上的ICH M7指引在2014年第三季度/第四季度;
常设委员会注意到所提出的时间表，M7的附录，以达到非物质文化遗产过程的步骤2。

M7 EWG: Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
The Rapporteur reported to the SC on the outcome of the M7 EWG meeting held in Minneapolis on 2 – 5 June 2014.
The SC noted that the EWG reached agreement on the addressing of all public comments received from regional consultation. The regulatory M7 experts signed-off the Step 4 M7 Guideline. The SC noted that implementation of ICH M7 was encouraged after publication, however because of the complexity of the Guideline; application of M7 is not expected prior to 18 months after ICH publication. Once the revision is published and required, companies would not be required to go back and test 1) marketed products and 2) products in P2b/P3 that had already been tested under previous expectations. The SC noted that the EWG would continue to review and discuss the proposed Addendum to ICH M7 which would contain the acceptable limits of known mutagenic impurities and supporting monographs. The group would work on the Addendum by teleconferences and expect to reach Step 2 in December 2014 after which the draft Addendum would be submitted for public comments under Step 3 of the ICH process.
SC Decisions/Actions:
 The SC supported the proposed implementation plan for the M7 Guideline;
 The regulatory members of the SC signed-off Step 4 of the M7 Guideline;
 The ICH Secretariat will organise a webinar on the ICH M7 Guideline in Q3/Q4 2014;
 The SC noted the proposed timeframe for the M7 Addendum to reach Step 2 of the ICH process.

yuansoul

领导，这个中文翻译是谁弄得？

还有，我对某坛的主要看法就是：说一套，做一套，做鱼肉的时候痛恨刀子，等做了刀子就开始剁肉馅。酱紫不好的。