1. 2022年美国FDA BIMO核查发现项汇总（GCP）

US FDA BIMO Inspectional Observations Summary for 2022 (GCP)

FDA发布BIMO 2022财年核查汇总。与药物临床试验质量管理规范相关的核查分为2大类：申办方/监查员/CRO核查，临床研究者核查。

The FDA has released their BIMO Fiscal Year 2022 Metrics. Below are the metrics related to Good Clinical Practice. GCP Inspections are broken into 2 major categories: Sponsor/ Monitor/ CRO inspections and Clinical Investigator inspections.

申办方/监查员/CRO核查：

· 该类核查占全年BIMO核查总数的11%，与前几年相似。

· 约19%的申办方/监查员/CRO核查结果为生成483表或警告信，与去年大致相同。

· FDA仅对申办方/监查员/CRO进行了一次远程监管评估（RRA），与上一年相比大幅下降（11次RRA或8%）。

Sponsor/ Monitor/ CRO Inspections key takeaways：

· Sponsor/ Monitor /CRO Inspections constituted 11% of total BIMO inspections in 2022, similar to prior years.

· About 19% of Sponsor/ Monitor/ CRO inspections resulted in a 483 or Warning Letter in 2022, which is about the same as last year.

· Only one Remote Regulatory Assessment was performed by FDA of Sponsor/ Monitor/ CROs in 2022 which was a big decrease from the prior year (11 RRAs or 8%).

申办方/监查员/CRO核查--2022年新的发现项：

· 未实行有效监查以确认研究按照方案或研究计划执行

· 不符合试验用器械豁免（IDE）的要求

· 未及时（在FDA批准研究后6个月内）向FDA提交所有参与研究者清单

Sponsor/ Monitor/ CRO Inspections – new deficiencies in 2022 noted in FDA slide deck:

· Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance with the protocol and/or investigational plan

· Failure to meet the abbreviated requirements for investigational device exemptions (IDEs)

· Failure to submit current list of all participating investigators to FDA at six-month interval after FDA approval of the study

申办方/监查员/CRO核查常见发现项（2020、2021年也有以下发现项）

· 未按照21 CFR 312.57保存或保留记录

· 试验用药品清点，研究者声明（FDA 1572表格），财务披露

· 未提交IND申请

Sponsor/ Monitor/ CRO Inspections – common S/M/CRO Deficiencies (the observations below also showed up in 2020 and 2021)

· Failure to maintain or retain adequate records in accordance with 21 CFR 312.57; 

· Accountability for the investigational product; Investigator Statement (Form FDA 1572); Financial disclosures

· Failure to submit an IND application

临床研究者核查：

· FDA进行的远程监管评估（RRA）中，8%是针对临床研究者，较上一年（25%）大幅下降。

· 约17%的临床研究者核查结果为生成483或警告信，与前几年一致。

· 临床研究者核查占BIMO核查总数的66%。

Clinical Investigator inspection key takeaways:

· 8% of remote regulatory assessments performed by the FDA in 2022 were of Clinical Investigators, which is large decrease from the prior year (which was 25%).

· About 17% of Clinical Investigator inspections resulted in a 483 or Warning Letter in 2022, in line with the prior years.

· Clinical Investigator Inspections constituted 66% of total BIMO inspections in 2022.

常见发现项（2020、2021年也有以下发现项）

• 未遵循研究计划，方案偏离

• 病历/研究记录不充分或不准确

• 试验用药品管理责任不充分

• 受试者保护不足，知情同意问题

• 未符合1572表的要求

• 安全性报告：未报告或未记录不良事件

Common Clinical Investigator Deficiencies noted in FDA slide deck (all the observations below also showed up in 2020 and 2021)

· Failure to follow the investigational plan; protocol deviations

· Inadequate and or inaccurate case history records/ study records

· Inadequate accountability for the investigational product

· Inadequate subject protection; informed consent issues

· Failure to comply with Form 1572 requirements

· Safety reporting: failure to report and or record adverse events

2. 2022年美国FDA BIMO核查发现项汇总（PV）

US FDA BIMO Inspectional Observations Summary for 2022 (PV)

FDA发布BIMO 2022财年核查汇总（2021年10月1日-2022年9月30日）。与药物警戒相关的核查包括上市后药物不良反应核查（PADE）和风险评估缓解策略（REMS）核查。

The FDA has released BIMO Fiscal Year 2022 Metrics. The US FDA has released their annual Summary of Inspectional Observations for Fiscal Year 2022 (01Oct2021-30Sep2022). Below are the metrics related to Good Pharmacovigilance Practice. This includes both Post-marketing Adverse Drug Experience (PADE) and Risk Evaluation Mitigation Strategies (REMS) Inspections.

上市后药物不良反应核查关键信息：

· PADE核查占BIMO全年核查总数的5%，较前几年略增。

· 约30%的PADE核查结果为生成483表，与大流行（新型冠状病毒疫情）前年份（2017-2019）相当。

· 远程监管评估（RRA）中仅有一项与PADE相关，这与过去2年中观察到的数量相比有所减少。

PADE Key Takeaways:

· PADE Inspections constituted 5% of total BIMO inspections in 2022, which was a small increase compared to prior years.

· About 30% of PADE Inspections resulted in a 483, similar to the numbers we saw in pre-pandemic years (2017-2019).

· Only one of FDA's remote regulatory assessments was related to PADE, which is a decrease from the numbers seen over the past 2 years.

常见发现项，也见于2021年报告：

· 未制定监测、接收、评价和/或报告上市后药物不良反应的相关流程

Common PADE Deficiencies – Repeat Issues from 2021:

· Failure to develop written procedures for the surveillance, receipt, evaluation, and/or reporting of post-marketing adverse drug experiences

新发现项（未见于2021年）：

· 未及时（自申请获批周年日起60日内）提交年度安全报告

· 未按时提交季度安全性报告

· 未调查严重，非预期事件

· 未保留记录，个体病例研究报告（ICSR）的初始报告者信息不完整

Common PADE Deficiencies – Not on the list in 2021 slide deck:

· Failure to submit annual safety reports within 60 days of the anniversary date of the approval of the application

· Late submission of quarterly safety report

· Failure to investigate serious, unexpected events

· Failure to maintain records; incomplete initial reporter information on individual case study reports (ICSR)

风险评估缓解策略（REMS）核查：

• REMS核查占全年BIMO核查总数的2%。

• 超过90%的REMS核查结果为生成483表，与大流行（新型冠状病毒疫情）前年份（2017-2019）相当

• 仅有一项FDA远程监管评估（RRA）用于REMS核查，与过去2年相似。

REMS Key Takeaways:

· REMS Inspections constituted 2% of total BIMO inspections in 2022.

· Over 90% of inspections resulted in a 483 in 2022, similar to the numbers we saw in pre-pandemic years (2017-2019).

· Only one of FDA remote regulatory assessments was focused on REMS, which is similar to the past 2 years.

常见的REMS发现项（也见于2021年）：

• 未遵守REMS执行体系；申请持有人未按照批准的REMS执行体系维持支持/呼叫中心或REMS项目网站

Common REMS Deficiencies (also seen in 2021):

• Failure to comply with REMS Implementation System; An application holder did not maintain a Support / Call Center or a REMS Program website, as required by approved REMS Implementation System

新发现项（未见于2021年）：

• 未遵守REMS沟通计划；未按照REMS中的发布日期向目标受众沟通，或未按照要求执行沟通计划

• 未按照批准的REMS用药指南来分发用药指南

New Issues (not on the list from 2021):

• Failure to comply with REMS Communication Plan; failure to distribute the Communication Plan in accordance with the distribution dates in the REMS, to the target audience, or use the Communication Plan as required

• Failure to dispense the Medication Guide, as required by approved REMS Medication Guide

3. 2022年美国FDA BIMO核查发现项汇总（GLP）

US FDA Inspectional Observations Summary for 2022 (GLP)

FDA发布BIMO 2022财年核查汇总。以下为与GLP核查相关信息。

The FDA has released their BIMO Fiscal Year 2022 Metrics.

Below you will find a breakdown of FDA Inspection Metrics for Fiscal Year 2022 specific to Good Laboratory Practice (GLP). 

GLP核查：

• GLP核查次数较上一年度翻倍（2021年是过去7年中最低一次）。

• 32%的GLP核查由CDER发起，36%由CBER发起（增加），32%由CDRH发起（减少）。

• 约30%的GLP核查结果为生成483表或警告信。

• GLP核查占全年BIMO核查总数的4%，与前几年持平

GLP inspection key takeaways:

· The number of GLP inspections doubled from the prior year 2021 (which had been the lowest number seen in the past 7 years).

· 32% of GLP inspections were initiated by CDER, 36% by CBER and 32% by CDRH.  This is an increase for CBER and decrease for CDRH.

· About 30% of GLP Inspections resulted in a 483 or warning letter in 2022.

· GLP Inspections constituted 4% of total BIMO inspections in 2022 which is on par with previous years

常见GLP核查发现项（也见于2021年）：

• 最终报告未包括影响数据质量或完整性的所有情况

Common GLP Inspection Observations – Repeat from 2021

· Final report did not include all circumstances affecting quality or integrity of the data

常见GLP核查发现项（未见于2021年）：

• 未校准设备：用于测量或评估的设备未完成适当的测试、校准和/或标准化

• 检测机构管理层未确保所有人员明确职责

• QA部门无适当授权和记录以确认方案偏离

• QA部门未能监测各研究以确保设施、设备、人员、方法、实践、记录和控制符合GLP法规要求

• 缺少标准操作规程（SOPs）

Common GLP Inspection Observations – Not listed in 2021 slides

· Equipment calibration, equipment used for measurement or assessment was not adequately tested, calibrated and/or standardized

· Testing facility management failed to assure that all personnel clearly understood the functions they were to perform

· QAU failed to determine if any deviations from approved protocols had been made without proper authorization and documentation

· QAU failed to monitor each study to assure management that facilities, equipment, personnel, methods, practices, records, and controls were in conformance with GLP regulations

· Missing standard operating procedures (SOPs)

4. US FDA指南：基于风险的监查（RBM）Q&A（2023年4月）

US FDA Final Guidance: A Risk-Based Approach to Monitoring (RBM) of Clinical Investigations Q&A (Apr 2023)

总结：

美国FDA发布了题为“基于风险的临床研究监查Q&A”的指南。2013年发布的RBM指南概述了申办方在制定和调整监查计划时应考虑的因素，并提供了监查方法和技术的示例。自2013年RBM指南定稿以来，FDA认为提供进一步的指南将有利于建议规划监查方法、制定监查计划以及处理和沟通监查结果。

Summary:

The US FDA has released a final guidance titled: A Risk-Based Approach to Monitoring (RBM) of Clinical Investigations Questions and Answers. An earlier 2013 RBM guidance outlines factors that sponsors should consider in developing a monitoring plan and tailoring monitoring plans to the needs of the investigation and provides examples of monitoring methods and techniques. Since finalizing the 2013 RBM guidance, FDA has concluded that additional guidance may be beneficial regarding its recommendations for planning a monitoring approach, developing the content of monitoring plans, and addressing and communicating monitoring results.

关键信息：

· 本文提供了在人用药品和生物制品、医疗器械、或组合产品的临床试验中实施基于风险的监查的相关信息。监查是确认研究活动是否按计划执行的一个质量控制工具。

· 本文扩展了2013版本临床研究行业监督指南——基于风险的监查方法（2013年RBM指南），为帮助申办方实施基于风险的监查提供更多信息。

Key Takeaways:

· This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products. Clinical investigation monitoring is a quality control tool for determining whether investigation activities are being carried out as planned.

· This guidance expands on the guidance for industry Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013) (the 2013 RBM guidance) by providing additional information to facilitate sponsors' implementation of risk-based monitoring.

5. US FDA指南草案：药品、生物制品与医疗器械去中心化临床试验（2023年4月）

US FDA Draft Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices (Apr 2023) 

美国FDA发布题为“药品、生物制品与医疗器械去中心化临床试验”的指南草案。在指南中，去中心化临床试验（DCT）是指部分或全部试验相关活动发生在传统临床试验研究中心以外的其它地点。FDA指出，无论是DCT还是传统临床试验研究中心，监管要求相同。

The US FDA has released a draft guidance titled: Decentralized Clinical Trials for Drugs, Biological Products, and Devices. In this guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.  FDA notes their regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials.

指南草案针对以下主题给予建议：DCT设计考虑；远程访视和临床试验相关活动；使用数字健康技术远程获取数据；申办方和研究者在DCT中的角色和职责；知情同意过程以及伦理委员会监督知情同意流程；试验用药品对于DCT的可适性；试验用药品在DCT中的包装和运输；以及对试验参与者进行安全性监测。

The new draft guidance covers recommendations on topics such as: design considerations for a DCT; conduct of remote clinical trial visits and clinical trial-related activities in a DCT; use of digital health technologies to remotely acquire data in a DCT; roles and responsibilities of the sponsor and investigators in a DCT; obtaining informed consent (IC) and institutional review board oversight of the IC process in a DCT; determination of the appropriateness of investigational products for use in a DCT; packaging and shipping of investigational products in a DCT; and safety monitoring of trial participants in a DCT.

关键信息：

· 去中心化临床试验将允许部分或所有临床试验相关活动在试验参与者的家中或其它便利地点进行，而不是必须访问研究中心。FDA预期这将增加临床试验参与者的广泛度和多样性，并提高特殊患者（罕见病或行动不便者）参与临床试验的可能性。

· 本指南草案以2020年发布的官方建议为基础，曾为研究者应对新冠政策及新冠疫情（如隔离、临床研究中心关闭、出行限制）等情况提供了明确指导。

Key takeaways:

· Decentralizing clinical trials will allow some or all trial-related activities to take place at trial participants' homes or other convenient locations, instead of having them visit research sites and FDA expects this will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges.

· This draft guidance builds on agency recommendations issued in 2020, which provided clarity for investigators to facilitate trial decentralization in response to the COVID-19 public health emergency and associated disruptions such as quarantines, site closures and travel limitations.

6. EMA更新了关于临床试验中IVRS使用的意见书，重点是关于有效期的处理（2023年3月30日）

EMA Updates Reflection Paper on the use of IVRS in Clinical Trials, Emphasis on the Handling of Expiry Dates (30Mar2023) 

总结：

EMA更新了标题为“关于在临床试验中使用交互式应答技术（交互式语音/网络应答系统）的意见书”，特别强调了有效期的处理。

以下参考文件已被删除：

· 2014年4月16日欧洲议会和理事会关于人用药品临床试验的536/2014号法规(EU)，以及废止指令2001/20/EC

· 2022年9月6日发布的欧盟委员会授权条例(EU)C(2022)6240修订的欧洲议会和理事会第536/2014号条例(EU)，涉及未获许可的研究用药品和未获许可的人用辅助药品的标签要求。

Summary:

The EMA has updated the guidance titled: Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates.

The following references have been deleted:

· Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

· Commission Delegation Regulation (EU) C(2022)6240 of 6 September 2022 amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use.

关键信息：

· 本意见书旨在就国家主管当局（NCAs）对此类系统的期望，特别是它们在处理试验药品（IMP）有效期方面的用途。

· 更新了参考文件章节，以删除过期的参考文件。

Key Takeaways:

· This paper seeks to provide guidance on what national competent authorities (NCAs) expect from such systems and in particular their use for handling of the expiry date of the Investigational Medicinal Product (IMP).

· The references section has been updated to remove outdated references.

7. EMA更新了GCP Q&A (2023年6月)

EMA Updates Q&A on GCP (June 2023)

总结：

EMA发布了修订后的GCP Q&A文件。他们在B部分（GCP事项）增加了修订后的问题和新问题，在D部分（与临床试验相关的研究受试者数据记录）增加了一个新问题。

B部分 - GCP事项

· 修订后的问题11：根据适用的欧盟法律和ICH E6，申办方是否可以委托服务提供者执行由研究者负责的试验相关任务、程序、职责和职能？

· 新问题18：对临床试验中使用的通用型应用程序的期望是什么？

D部分 - 与临床试验相关的研究受试者数据记录

问题3：在临床试验中，当需要直接远程访问可识别的个人数据和健康数据时，需要考虑什么？

它描述了：

· 试验参与者的知情同意

· 依据法规(EU)第536/2014号的临床试验方案

· 技术考量：

o 授权访问的地点

o 信息传递

o 访问信息的场所

Summary:

The EMA has released a revised GCP Q&A document.  They have added a revised question and a new question in section B titled: GCP Matters，and a new question in section D (Records of study subject data relating to clinical trials).

Section B - GCP Matters:

· Revised Question 11: According to the applicable EU laws and ICH E6 is it allowed that the sponsor could contract service providers to conduct trial-related tasks procedures, duties, and functions that are under the responsibility of the investigator?  

· New Question 18: What are the expectations for productivity applications used in clinical trials?

Section D - Records of study subject data relating to clinical trials:

Question 3: What are the considerations when direct remote access of identifiable personal and health data is required in a clinical trial?

It describes:

· Informed consent of the trial participant

· Clinical trial protocol according to Regulation (EU) No. 536/2014

· Technical considerations for:

o the place where access is granted

o transmission of information

o the place where access is made to the information

关键信息：

· EMA增加了一个关于临床试验中使用的通用型应用程序的新问题，该应用程序是用于产生信息的软件（例如文件、演示文稿、工作表、数据库、图表）。

o 为了使监管部门能够评估所采取的措施是否适当，在临床研究报告（质量保证章节）中详细说明使用需要采取特定措施的通用型应用程序和以及所采取的措施（如有）是合理的。

· 他们还修改了允许申办方代表研究者与服务提供商签约的问题，以与他们最近“关于临床试验中去中心化要素的建议”文件所述保持一致。

· EMA增加了一个临床试验中需要直接远程访问可识别的个人数据和健康数据的新问题。

Key Takeaways:

· The EMA has added a new question about productivity applications used in clinical trials, which are software used for producing information (e.g. documents, presentations, worksheets, databases, charts).

o In order for the authorities to be able to assess whether the measures taken are appropriate, the use of productivity applications requiring specific measures and the measures taken, if any, are expected to be detailed and justified in the clinical study report (section on quality assurance).

· They also revised their question on allowing sponsors to contract service providers on behalf of the investigator to align with what is stated in their recent Recommendation paper on decentralised elements in clinical trials.

· The EMA has added a new question about direct remote access of identifiable personal and health data required in a clinical trial.

8. MHRA GCP 检查年度报告（2019年4月-2020年3月）

MHRA Annual GCP Inspections Metrics Report (Apr 2019-Mar 2020)

MHRA发布了GCP检查年度报告（2019年4月-2020年3月）。

The MHRA has released its annual GCP Inspections Metrics Report (Apr 2019-Mar 2020).

有关商业申办方的关键信息：

· 由于COVID-19大流行，针对商业申办方的检查较上一报告期显著减少。

· 药物警戒问题仍然是最常见的严重（Critical）问题，也是2020年唯一的严重问题。

· 不同于往年，记录保存/基本文件、方案合规性和数据完整性方面未发现严重问题。

· 药物警戒趋势与最近3年的发现结果，和MHRA药物警戒检查对安全性参考信息（RSI）的关注一致。

· 在7次商业申办方检查中，6次为系统检查，1次触发检查（前一年有1次触发检查）

· 在7次检查中，4次(57.1%)至少有1个严重问题（critical finding），所有(100.0%)至少有1个重大和/或严重问题（major and/or critical finding）。

· 特别指出一家公司不符合Q&A指导性文件的情况。

Key Takeaways for Commercial Sponsors:

· Commercial Sponsor inspections have decreased significantly from the prior reporting period due to the COVID-19 Pandemic.

· Pharmacovigilance observations continue to be among the most frequent Critical observations and the only critical observation in 2020. 

· No critical Observations were seen in Record-Keeping/ Essential Documents, Protocol Compliance or Data Integrity as seen in prior years.

· The PV trend is consistent with the last 3 years' findings and the MHRA's focus on Reference Safety Information (RSI) during Pharmacovigilance Inspections.

· Of the 7 Commercial Sponsor inspections, 6 were systems inspections, and 1 triggered inspection. (there was one triggered inspection the previous year)

· Out of the seven inspections, four (57.1%) had at least one critical finding and all (100.0%) had at least one major and/or critical finding.

· There is a specific call out to a company's noncompliance with a Q&A Guidance Document.

有关研究中心的关键信息：

· 共检查了12家研究中心，所有研究中心均与申办方/CRO/非商业/临床试验单位(CTU)检查相关。

· 作为相关研究中心，检查的重点是申办方/合同CRO如何监督研究中心。

· 在报告的12项研究者检查中：没有发现严重问题（critical finding），10项(83%)至少有一项重大问题（major finding）。

· 占比最大的研究中心重大问题的类别是CRF数据/源数据，这与上一期的报告结果相似。

· 其他数量较多的重大问题的类别包括：IMP管理和PI的医疗监督。

Key Takeaways for Investigator Sites:

· A total of 12 investigator sites were inspected and all were as an associated site with a sponsor/CRO/non-commercial/Clinical Trial Unit (CTU) inspection.

· As associated sites, the emphasis of the inspection was on how the investigator site had been overseen by the sponsor/contracted CRO.

· Of the 12 reported investigator inspections: 0 had critical findings and 10 (83%) had at least one major findings.

· The largest number of major findings for Investigator Sites were in the category of CRF Data/Source Data Category, this is similar to findings in the prior reporting period. 

· Other areas with a large number of major findings included: IMP Management and Medical Oversight by the PI.

9. MHRA更新临床试验GCP检查文件数据表（2023年4月6日）

MHRA Updates GCP inspection Dossier Clinical Trial Spreadsheet (06Apr2023)

总结：

MHRA更新了临床试验质量管理规范指南。编写本文件的目的是说明如何向MHRA展示您是否符合药品临床试验质量管理规范(GCP)标准，以及预期会进行哪些检查。

· 使用GCP检查资料模板和临床试验GCP检查文件数据表帮助您准备资料，确保您的资料完整。

· MHRA将商定检查日期，并向您提供检查组信息以及实际的检查后勤方面的信息。

· 偶尔，在审查申报资料后，组长检查员可决定不继续进行检查。

Summary:

The MHRA has updated their Guidance on Good clinical practice for clinical trials.  The document was written to describe how to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection. 

· Use the GCP inspection dossier template and the GCP inspection dossier clinical trial spreadsheet to help you prepare your dossier. Use the GCP inspection dossier checklist to ensure your dossier is complete.

· MHRA will agree an inspection date and give you information on the inspection team and the practical logistical aspects of the inspection.

· Occasionally, after reviewing the dossier, the lead inspector may decide not to proceed with the inspection

· 

关键信息：

· MHRA已更新了本指南中的临床试验GCP检查文件数据表，申办方应将其与前一版本进行比较，以确保合规性。

Key Takeaways:

The MHRA has updated the GCP inspection dossier clinical trial spreadsheet in this guidance, sponsors should compare this to the previous version to ensure compliance.

10. 英国MHRA发布了作为医疗器械的软件和人工智能的监管指南（2023年4月）

UK MHRA Publishes Regulatory Guidance on Software and Artificial Intelligence as a Medical Device (Apr 2023)

总结：

MHRA发布了标题为“作为医疗器械的软件和人工智能（AI）”的指南。其制定旨在涵盖创新器械-软件组的输出。MHRA创建了该小组，以确保软件和人工智能作为医疗器械（SaMD/AIaMD）的安全性和访问权限。

Summary:

The MHRA has released a guidance titled: Software and Artificial Intelligence (AI) as a Medical Device.  It was written to cover the outputs of its Innovative Devices – Software Group. MHRA created the group to ensure the safety of, and access to, Software and Artificial Intelligence as a Medical Device (SaMD/AIaMD).

关键信息：

· 软件（包括AI）在健康和社会护理中发挥着重要作用。在英国，许多这样的产品被作为医疗器械（或体外诊断医疗器械（IVD））进行监管。

· 本指南提供了对重要软件组的输出的访问，这些输出可能有帮助。

Key Takeaways:

· Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices (or as in vitro diagnostic medical devices (IVDs).

· This guidance provides access to important Software Group outputs that might be of assistance.

11. MHRA更新了QPPV（包括PSMF）的指南（2023年5月）

MHRA Updates Guidance on QPPV including PSMF (May 2023)

总结：

MHRA更新了关于合格的药物警戒负责人（QPPV）指南，包括药物警戒系统主文件（PSMF）。

Summary:

The MHRA has updated its Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF). 

关键信息：

· 重写的章节：“现有英国上市许可持有人向MHRA通知QPPV和PSMF的详细信息”。

· 更新了先前提交IA类(IN)变更和随附eCTD序列进行这些变更的要求。已对此进行了简化，仅需通知更新，无需再提交eCTD序列。

Key Takeaways:

· A section of the guidance has been rewritten: 'Notification of QPPV and PSMF details to the MHRA by existing holders of UK marketing authorisations'.

· This guidance replaces the previous requirement to submit a Type IA(IN) variation and an accompanying eCTD sequence to make these changes. This has been simplified and only an update notification is required, there is no requirement to submit an eCTD sequence.

12. 在警戒系统中上报涉及软件作为医疗器械的不良事件（2023年5月）

MHRA Guidance on Reporting Adverse Incidents Involving Software as a Medical Device under the Vigilance System (May 2023) 

MHRA发布了在警戒系统中上报涉及软件作为医疗器械的不良事件的申办者指南。

本文件描述了：

· 报告内容

· 如何报告

· 可报告的不良事件类型示例

The MHRA has released Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system.

The document describes:

· What to report

· How it should be reported

· Examples of types of adverse incidents that may be reportable

关键信息：

· 符合三项报告标准（MEDDEV 2.12/1版本8，5.1.1）的任何事件均被视为不良事件，必须向MHRA报告。

· 对于作为医疗器械（SaMD）的软件，间接损害是不良事件最可能的结果，这可能是医疗保健专业人员和/或患者和公众根据SaMD提供的信息或结果作出了医疗决策，采取/未采取措施而导致的。

Key Takeaways:

· Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must be reported to the MHRA.

· For software as a medical device (SaMD), indirect harm is the most probable outcome of adverse incidents and may occur as a consequence of the medical decision, action taken/not taken by healthcare professionals and/ or patients and the public based on information or result(s) provided by the SaMD.