近日，国际药品监管机构联盟(ICMRA)宣布启动两个监管合作试点，包括对工厂设施的混合检查，以及化学和制造控制（CMC）和批准后变更（PAC）提交评估以及相关监管行动的协作。

这两个项目，一个侧重于CMC提交的协作评估，另一个侧重于混合检查。混合检查即由多个国家监管机构 (NRA) 使用现场检查（由一个 NRA）和远程检查（由至少一个 NRA）同时对同一生产设施进行评估的方式，以便更快地向患者供应关键药物，并克服大流行带来的出行限制和后勤挑战。

该项目适用于计划向多个监管机构提交新产品申请或已批准产品的批准后变更的申办者。

国际药品监管机构联盟(ICMRA)是由中国NMPA、欧盟EMA、美国FDA和日本PMDA等二十多个国家监管机构组成的国际组织。ICMRA表示，他们已经认识到，现代药物的开发，制造和供应是全球性的，更具全球性的监管药品质量知识管理（PQ KM）能力将提高监管机构随时共享和利用可能已经收到或收集的信息的能力。 这包括有关制造设施、产品、上市许可申请和上市许可持有人的信息。 这种PQ KM能力可以支持对设施和批准后CMC变更进行更简化的监管评估，并促进有效的行业制药质量管理，支持新药的开发和已经批准关键药物的持续可用性。 

翻译如下：

Pharmaceutical Quality – Regulatory Collaboration Pilots: Call for Industry Applications

国际药品监管机构联盟(ICMRA)监管合作试点项目

SUMMARY

概述

ICMRA is announcing the initiation of two regulatory collaboration pilots addressing facility inspections and Chemistry and Manufacturing Controls (CMC) and Post-Approval Change (PAC) submission assessments and related regulatory actions. The pilots are being operationalized under the auspices of ICMRA to explore the feasibility and potential for further collaboration and convergence among regulators in specific data expectations and assessment approaches when assessing manufacturing facilities for Pre-Approval and Pre-License Applications (PAIs & PLIs) and reviewing PACs and PAC Management Protocols. 

国际药品监管机构联盟(ICMRA)宣布启动两个监管合作试点，涉及工厂设施检查以及化学和制造控制（CMC）和批准后变更（PAC）提交评估以及相关监管行动。 这些试点项目正在ICMRA的主持下进行，以探索监管机构在评估生产设施的预批准和预许可申请（PAI和PLI）以及审查PAC和PAC管理方案时，在特定数据期望和评估方法方面进一步合作和融合的可行性和潜力。

The two pilots, one focused on collaborative assessments of CMC submissions, and the other on hybrid inspections, are to inform pre-market or PAC CMC assessment of drug applicants. Each of the pilots will involve two or more National Regulatory Authorities collaborating in the effort.  Please note that the actual post approval change submission should follow the normal regulations and procedures in each participating region.

这两个试点项目，一个侧重于CMC提交的协作评估，另一个侧重于混合检查，旨在为药物申请人的上市前或批准后变更 CMC评估提供信息。每个试点项目都将涉及两个或多个国家监管机构合作开展这项工作。 请注意，实际的批准后变更提交应遵循每个参与地区的正常规定和程序。

Each pilot aims to conduct three assessments or collaborative hybrid inspections over an anticipated duration of 1-1.5 years, and then issue learnings and recommendations on how to operationalize these programs in the future to benefit Industry and Regulators. More information related to the vision, goals, and specific considerations for each of the pilots is provided the Supplementary Information section below.

试点项目的目标是在1-1.5年的预期持续时间内进行三次评估或协作混合检查，然后就未来如何实施这些计划以造福行业和监管机构发表经验和建议。有关每个试点的愿景、目标和具体考虑因素的更多信息，请参见下面的补充信息部分。

Industry sponsors are invited to apply to participate in one or both collaboration pilots.

邀请行业申报方申请参加一个或两个协作试点。

Who can apply?

谁可以申请？

• Sponsors planning to file     an application for a new product or for post approval changes of approved     products to more than one Regulatory Agency. The proposal should focus on     therapeutics (including both small molecule and biological products),     which can include products intended for the treatment of patients with     COVID-19, Breakthrough/ PRIME/ Sakigake, etc. products, or products deemed     medically necessary/critical medicine.  The submission should be     intended to be submitted to multiple regulatory authorities at the same     time and should be provided to all participating regulatory     authorities. 

• 计划向多个监管机构提交新产品申请或已批准产品的批准后变更的申办者。侧重于治疗药物（包括小分子和生物制品），其中可以包括用于治疗COVID-19患者的产品，突破性疗法产品，或被认为医疗必须/关键药物的产品。 提交的内容应旨在同时提交给多个监管机构，并应提交给所有参与的监管机构。

• Sponsors intending to     submit a proposal for the inspection pilot should confer with the     management of the facility and ensure that the facility will be inspection     ready and can host a collaborative hybrid inspection. The facility should     satisfy themselves that they have appropriate IT infrastructure,     availability of necessary interpretation service and can co-ordinate with     at least two inspectorates across different time-zones. Please refer to     the Application form for further detail on necessary requirements.

• 打算提交检查试点的申请人应与工厂管理层进行协商，并确保工厂设施准备好检查，并可以进行协作混合检查。设施应确保他们拥有适当的IT基础设施，提供必要的口译服务，并且可以与不同时区的至少两个检查机构进行协调。有关必要要求的更多详细信息，请参阅申请表（点击阅读原文）。

SUPPLEMENTARY INFORMATION

补充信息

Background: 

背景

ICMRA recognizes that development, manufacture, and supply of medicines is now global, and a more global regulatorypharmaceutical quality knowledge management (PQ KM) capability would improve regulators’ ability to readily share and utilize information that may already be received or collected.  This includes information on manufacturing facilities, products, marketing authorization applications and marketing application holders.  This PQ KM capability could support more streamlined regulatory assessment of facilities and of post-approval CMC changes and promote effective industry pharmaceutical quality management supporting both development of new medicines and continued availability of already approved critical medicines.  

ICMRA认识到，现代药物的开发，制造和供应是全球性的，更具全球性的监管药品质量知识管理（PQ KM）能力将提高监管机构随时共享和利用可能已经收到或收集的信息的能力。 这包括有关制造设施、产品、上市许可申请和上市许可持有人的信息。 这种PQ KM能力可以支持对设施和批准后CMC变更进行更简化的监管评估，并促进有效的行业制药质量管理，支持新药的开发和已经批准关键药物的持续可用性。 

ICMRA began exploration of this with a July 2021 ICMRA-Industry workshop as part of a joint effort to expand availability of COVID-19 therapeutics and vaccines by increasing manufacturing capacity.  The ICMRA workshop highlighted the need for more convergence on CMC aspects between regions to allow faster supply of critical medicines to patients and the need to overcome travel logistical challenges created by the pandemic through use of hybrid inspections.  This identified need has motivated the planning of these two collaboration pilots.

In terms of the two focus areas these ICMRA collaboration pilots aim to achieve the following:

ICMRA于2021年7月在ICMRA行业研讨会上开始探索这一点，作为通过提高生产能力来扩大COVID-19治疗药物和疫苗可用性的共同努力的一部分。  ICMRA研讨会强调，各地区之间需要在CMC方面更加趋同，以便更快地向患者供应关键药物，并需要通过使用混合检查来克服大流行带来的出行和后勤挑战。 这一确定的需求促使了这两个合作试点项目的规划。就两个重点领域而言，这些ICMRA合作试点旨在实现以下目标：

• Develop an initial common     framework for collaborative assessment and hybrid inspections.

• 为协作评估和混合检查制定一个初步的通用框架。

• Deliver a single list of     questions to the sponsor or manufacturer wherever possible, and identify     any misalignments, differences, and potential areas for alignment or harmonization     across participating regulators’ regions.

• 尽可能向申请人或制造商提供单一问题列表，并识别参与监管机构所在地区之间任何不一致、差异和潜在的协调领域。

• Share application     sponsors’ or manufacturer responses between the participating quality     assessors/inspectors who will work towards a common approach to assessment     and decision making.

• 在参与的质量评估员/检查员之间共享申请人或制造商的回复，他们将致力于评估和决策的共同方法。

• Identify best practices     and standards in the quality assessment of CMC post-approval changes and     collaborative hybrid inspections to inform relevant quality assessments.
  

• 确定CMC批准后变更和协作混合检查质量评估的最佳实践和标准，为相关质量评估提供信息。

• Identify the conditions     (products/ cases) where cross-regional collaboration efforts in the     collaborative assessment and hybrid inspection pilots should focus and     make recommendations to ICMRA for a future cross-regional pathway(s)

• 确定协作评估和混合检查试点中的跨区域协作工作应重点的条件（产品/案例），并向ICMRA提出未来跨区域途径的建议