The Medicines and Healthcare products Regulatory Agency (MHRA) have released updated information and guidance on a range of medical devices for users and patients. Visit the gov.uk website here to read the updated guidance.

On 18-Jul-2023, Jamie Toth (HSRAA Chair) attended the MHRA GCP StEM in Canary Wharf, London.  Karen Roy, CDISC TMF Reference Model Chair, also was in attendance along with 40 other representatives across industry and various sectors impacted by the ICH E6 (R3) changes.  The group in attendance had the opportunity to

The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics. Read in full HERE

The vision on Big Data is a strengthened regulatory system that can efficiently integrate data analysis into its assessment processes to improve decision making. Knowing when and how to have confidence in novel technologies and the evidence generated from Big Data will benefit public health by accelerating medicines development, improving

ICH has published a new Reflection Paper: International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines The Reflection Paper (endorsed by the Assembly in June 2023) presents opportunities for development of new

The OECD has published its Advisory Document on GLP & Cloud Computing – Supplement 1 to Document Number 17 on Application of GLP Principles to Computerised Systems, release date 29th June 2023. This document describes the expectations that GLP Compliance Monitoring Authorities have of GLP test facilities which use cloud-based

ICH recently released a new draft of the ICH E6 (R3) guidelines. While the finalised version is set for release at the end of 2023, we can see what is expected to be published. The ICH E6 (R3) Guideline details the responsibilities of those involved in clinical trials to ensure the safe

As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, it has identified in this discussion paper areas for which public feedback would be valuable.  Read in full HERE

The MHRA has updated its published “Guidance on Borderline Products: How to Tell if your Product is a Medical Device and which Risk Class Applies”. The revisions comprises an additional section ‘Annex A – MHRA borderline determinations’ to assist manufacturers to arrive at the appropriate classification for their products. Read in

Andrew Fisher, Lead Senior GCP Inspector, has written a blog about the changes to the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline now that the updated version R3 has reached Step 2b and is available for public consultation.  Read in full HERE

This newly published European Medicines Agency ‘Questions and Answers Document’ provides answers to commonly asked questions about the proof-of-concept pilot on the submission and analysis of ‘raw data’ from clinical studies as part of selected initial marketing authorisation applications and post-authorisation applications submitted to the European Medicines Agency. The document

An updated version of the DPC’s Preservation Toolkit has been shared, which improves the previous version by building on the work and feedback of their community. This toolkit offers information and resources to help you understand more about digital preservation requirements, practical steps for analysing your digital records and helpful

Artificial Intelligence writers and chatbots have seen huge success following a boom started by ChatGPT since its launch in November 2022. As ChatGPT grows so too does the scepticism. Such Large Language Models (LLMs), may improve efficiency and harness creativity but they are not without risk. The UK’s National Cyber

It’s unlikely that Bob Dylan was writing about the trial master file in his 1964 hit song, “The Times They Are a-Changin”. And yet, 59 years later, one could argue that it’s become a fitting anthem for the state of the industry. For more information and insights on this topic,

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two new Good Distribution Practice (GDP) guidance documents that came into force in Feb 2023  The documents are available to download here: https://picscheme.org/en/publications

The FDA has released its BIMO inspection metrics for year 2022. These metrics give you useful information on inspections performed throughout 2022 and observations raised (compared to previous years). With more inspections due to be conducted this year, get inspection ready and take a look at these findings, by clicking