EDQM：PDG将其它ICH成员药典纳入Q4B项目

Q4B是评估药典间差异的项目，之前仅评估USP、EP和JP的，目前扩大到所有ICH成员国，已有三篇正在试行评估：含量均匀度、溶出度和无菌测试。20210年10月EDQM主办的会议中PDG将更新其状态。

PDG’s efforts to engage other ICH pharmacopoeias in the Q4B Annexes maintenance process 

PDG致力于将其它ICH药典纳入Q4B附件维护项目

At its November 2020 meeting, the ICH Assembly approved the proposal made by the PDG (Pharmacopoeial Discussion Group) on how to include the pharmacopoeias of the non-Founding ICH Regulatory Members in the maintenance of the ICH Q4B Annexes. The expansion of ICH membership provides an excellent opportunity to further promote the global convergence of pharmacopoeial quality standards, through the extended recognition – potentially by all ICH Regulatory Members – of the harmonised pharmacopoeial texts referenced in the Q4B Annexes. The PDG has now reached the first crucial milestone in its efforts to involve the pharmacopoeias of non-Founding ICH Regulatory Members in this work.

在 2020 年 11 月的会议上，ICH 大会批准了 PDG（药典讨论组）提出的关于如何将 ICH 非创始监管成员的药典纳入 ICH Q4B 附录维护的提案。ICH 成员壮大为通过扩大成员（可能是所有ICH监管成员）互认Q4B附录中的药典正文进一步促进全球药典质量标准的趋同提供了绝佳的机会。 PDG 现在已经达到了让 ICH 非创始监管成员的药典参与这项工作的第一个关键里程碑。

The “Q4B process”, the process for the “evaluation and recommendation” of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable by the ICH Regulatory Members, is separate from the process for pharmacopoeial harmonisation in PDG.  Following evaluation in the “Q4B process”, topic-specific annexes with information about these texts and their implementation are issued.

“Q4B 项目”，即对选定药典文本进行“评估和推荐”以促进ICH监管机构成员认可其互换性的流程，与 PDG 中的药典协调过程是分开的。在“Q4B 项目”中进行评估后，会发布包含有关这些药典正文内容及其实施信息的特定主题附件。

The process was initially the responsibility of the ICH Q4B Expert Working Group (EWG) until it was disbanded at the end of 2010. The PDG took over this responsibility and the maintenance of the existing Q4B Annexes in November 2018.

该项目最初由 ICH Q4B 专家工作组 (EWG) 负责，后于 2010 年底解散。PDG 于 2018 年 11 月接管了这一职责并维护了现有的 Q4B 附录。

The current Q4B Annexes cover texts from the three PDG pharmacopoeias and include declarations of interchangeability by ICH Founding and Standing ICH Regulatory Members only [i.e. EC (Europe); FDA (United States); MHLW/PMDA (Japan); Health Canada (Canada); Swissmedic (Switzerland)]. However, since the Q4B Annexes were last updated by ICH Q4B EWG, the ICH has expanded its membership to include additional Regulatory Members whose pharmacopoeias may include texts impacted by the Q4B Annexes.

当前的 Q4B 附件涵盖了三个 PDG 药典的文本，并且仅包括 ICH 创始成员和常任 ICH 监管成员的互换性声明【即EC（欧洲）、FDA（美国）、MHLW/PMDA（日本）、加拿大卫生部（加拿大）、Swissmedic（瑞士）】。但自从 Q4B 附件由 ICH Q4B EWG 上次更新以来，ICH 已扩大其成员资格以包括其他监管成员，其药典可能包含受 Q4B 附件影响的内容。

In April 2020, the PDG submitted a detailed proposal on how to extend the scope of the Q4B process to pharmacopoeial texts of the non-Founding ICH Regulatory Members to the ICH Management Committee and ICH Assembly. The PDG also recommended launching a “proof of concept” pilot study on three selected Q4B Annexes – Annex 6: Uniformity of Dosage Units, Annex 7: Dissolution and Annex 8: Sterility – before considering extending the proposal to all others.

2020 年 4 月，PDG 向 ICH 管理委员会和 ICH 大会提交了一份关于如何将 Q4B 项目的范围扩展到非 ICH 创始成员的药典内容的详细提案。 PDG 还建议对三个选定的 Q4B 附件（附录 6：含量均匀度、附录 7：溶出度和附录 8：无菌检测）启动“概念证明”试点研究，然后再考虑将提案扩展到所有其他附件。

This proposal was approved by the ICH Assembly in November 2020.

The PDG has since contacted the pharmacopoeias of the non-Founding ICH Regulatory Members and asked them to evaluate their own texts versus the PDG sign-off texts and to inform the PDG if they have implemented the PDG sign-off texts or if they consider their own texts as already harmonised with them. They were also asked to provide the PDG with a detailed review of potential residual differences as well as an English version of their pharmacopoeial texts. This process is liable to take several months.

该提案于 2020 年 11 月获得 ICH 大会的批准。

此后 PDG 联系了 ICH 非创始监管成员的药典，并要求他们评估自己的文本与 PDG 签署文本的对比，并通知 PDG 他们是否已经实施了 PDG 签署文本，或者他们是否认为自己的内容已经与其协调一致。他们还被要求向 PDG 提供潜在残留差异的详细审查以及药典内容的英文版本。这个过程可能需要几个月的时间。

The PDG will review the feedback from these pharmacopoeias and, where appropriate, update the Q4B Annexes with additional information on the acceptance by additional ICH Regulatory Members. The revised Q4B Annexes will be submitted to the ICH secretariat which will then launch a consultation among the ICH Regulatory Members. This consultation will focus on the regulatory considerations in the Q4B Annexes.

PDG 将审查这些药典的反馈，并在适当的情况下更新 Q4B 附件，其中包含有关其他 ICH 监管成员接受的更多信息。修订后的 Q4B 附件将提交给 ICH 秘书处，然后该秘书处将在 ICH 监管成员之间发起磋商。本次咨询将重点关注 Q4B 附件中的监管考量。

The PDG will provide a status update to the ICH Assembly after the PDG Annual Meeting, which will be hosted by the EDQM in October 2021.

PDG 将在 PDG 年会之后向 ICH 大会提供状态更新，该年会将于 2021 年 10 月由 EDQM 主办。

(*) the PDG brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with WHO as an observer.

（*）PDG汇集了EP、JP和USP，WHO为观察方。