The International Council for Harmonisation (ICH) has announced the ICH M14 guidance on use of real-world data (RWD) to support drug development has reached Step 2 of the ICH process. The M14 guideline on the principles for planning, designing and analysing pharmacoepidemiologic studies that use RWD for assessing medicines is now also open for public consultation. The guidance aims to provide a multidisciplinary guideline to harmonise post-approval non-interventional studies on drugs, vaccines, and other biologics using RWD. The guidance provides recommendations and 'high-level best practices' for conducting RWD studies. It also includes a framework for generating adequate evidence using RWD, the research question to be addressed by these studies, the use of feasibility assessments to identify fit-for-purpose data to address a specific research question, and the development of a protocol to address the design and conduct of pharmacoepidemiological safety studies using subject matter experts. The consultation will close on 30 September 2024.

The International Council For Harmonisation (ICH) has opened its E2D guideline for public consultation. It was transmitted to the Committee for Human Medicinal Products (CHMP) of the European Medical Association (EMA) and adopted on 22 February 2024 when the public consultation opened for comment until 22 June 2024 in the EU. The ICH E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as well as good case management practices. This revised guideline is proposed to clarify the management of post-approval safety information from new or increasingly used data sources including the need to adapt definitions and standards. In addition, the revised guideline provides recommendations that are harmonised as far as possible given the differences in post-market safety reporting requirements among ICH regions.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published its E20 draft guideline on Adaptive Design for Clinical Trials, which reached Step 2b of the ICH process on 25 June 2025 and has entered the Step 3 public consultation phase. Adaptive clinical trials, which allow modifications based on interim data, currently face inconsistencies in terminology, design principles and documentation requirements across regions, hindering global drug development. The ICH E20 draft guideline aims to harmonise these standards, focusing on principles for the planning, conduct, analysis and interpretation of clinical trials using adaptive designs.

The International Council for Harmonisation (ICH) has published an updated Q9(R1) quality risk management (QRM) briefing pack, intended to support a systematic approach to QRM across pharmaceutical development, manufacturing and distribution. It comprises an introductory presentation, nine training presentations on QRM methods and tools and nine presentations on potential QRM applications. ICH states that the updated briefing pack is part of broader training resources designed to support implementation of the revised Q9(R1) guideline and enable an integrated lifecycle approach to pharmaceutical quality systems that protects patients.

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued a Request for Information (RFI) seeking market consultation on implementing a scalable technology solution for global multi-regulatory collaborative assessments. ICH aims to gather feedback on creating a secure platform facilitating collaboration between regulatory authorities and potentially sponsors. The organisation emphasises that this RFI does not constitute a contractual offer or commitment, and responses will be reviewed by ICH and its representatives. ICH has highlighted data protection considerations for international information transfer and set a response deadline of 4 November 2024.

On 25 June 2026, the Home Office published a report by the Independent Chief Inspector of Borders and Immigration (ICIBI) on refusals and cancellations of permission to enter the UK, along with the Home Office’s response. Four other reports were published on the same day. This report had originally been sent to Home Secretary on 16 April 2026. This inspection examined Border Force’s processes for refusing and cancelling permission to enter at airports, seaports and juxtaposed controls, and assessed preparations for a digitised, contactless border. The report found that, although no erroneous decisions were found in the sample, in general the current arrangements do not constitute a coherent national system, with no overarching strategy or senior responsible owner within Border Force. The inspection also found significant issues with the planning for the digital transition, data keeping, training and learning cultures.

The Independent Chief Inspector of Borders and Immigration (ICIBI) has published a new report on asylum contingency accommodation, which includes inspections of the controversial housing at Wethersfield and Napier camps and the Bibby Stockholm Barge. The ICIBI makes nine recommendations, which have all been accepted in whole or part by the government, including a key recommendation about improving communication with asylum seekers and stakeholders.

On 25 June 2026, the Home Office published a report by the Independent Chief Inspector of Borders and Immigration (ICIBI) on administrative reviews, along with the Home Office’s response. Four other reports were published on the same day. This report had originally been sent to the Home Secretary on 17 October 2025. This inspection was conducted under former Chief Inspector David Bolt and examined the administrative review (AR) system ten years after ARs replaced a range of rights of appeal to the Immigration and Asylum Tribunal. The report—the third full ICIBI inspection of the AR system—found the system to be a long way from working as intended, with some recommendations explicitly repeating those made in 2016 and 2020. One key finding concerned processing times: the original 28-day service standard was abandoned in 2021 and GOV.UK now advises applicants that processing can take 12 months or more.

The Independent Chief Inspector of Borders and Immigration (ICIBI) has called for evidence on Home Office age assessments, with a particular focus on the Illegal Migration Intake Unit, the Asylum Intake Unit and the National Age Assessment Board. The deadline to submit evidence is 25 September 2024 and all aspects of age assessments are being investigated, including guidance, training, record keeping, quality assurance and stakeholder engagement.

The Independent Chief Inspector of Borders and Immigration (ICIBI) has announced the commenced inspection of the benefits generated by, and facilitated through, the Future Border and Immigration System (FBIS) programme, in accordance with the 2026–27 Inspection Plan. This inspection will examine the effectiveness of transitioning benefits from the Digital Permissions delivery area into business-as-usual operations, the realisation of Electronic Travel Authorisation and eVisa fee income benefits and the arrangements in place to track the benefits of the Border Vision project enabled by FBIS. The inspection team anticipates reporting its findings to the Home Secretary by July 2026.

The Independent Chief Inspector of Borders and Immigration (ICIBI) has launched an inspection into the Home Office’s engagement with local authorities regarding the planning and development of asylum accommodation.

The Independent Chief Inspector of Borders and Immigration (ICIBI) has published its annual report for 2024-25, laid in Parliament on 4 September 2025. In relation to general themes, the report identifies continuing systemic issues at the Home Office including poor record-keeping, ineffective oversight, staffing difficulties and IT system problems. These longstanding problems need to be addressed at a time of heavy workloads and reducing budgets. While publication timeframes improved with five of six reports released within eight weeks during 2024-25, the ICIBI faces reduced inspection capacity for 2025-26 due to budget constraints that make its agreed 30-person headcount no longer sustainable. The report notes that stakeholder engagement remains a key challenge for the Home Office in building trust and transparency in border and immigration control.