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News Archive
MHRA - CE marking recognition for medical devices and in vitro diagnostics
2nd August 2023The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.
WHO - Public consultation on WHO guidance for best practices for clinical trials
27th July 2023In May 2022, the Seventy-fifth World Health Assembly adopted a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, in which one action requested of the Director-General was to develop WHO guidance on best practices for clinical trials. Please see action 2 under section “Requests the Director-General” at the end of WHA 75.8 resolution here. WHO is launching a public consultation on draft guidance developed in line with this request.
EMA - CTIS Newsletter July 2023
20th July 2023EMA is pleased to share that the 15th issue of the ‘Clinical Trials Highlights’ newsletter has been published. The newsletter provides insights on clinical trials topics, including on the ACT EU initiative and CTIS.
EMA - Reflection paper on the use of artificial intelligence in the lifecycle of medicines
20th July 2023EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public consultation, reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicines’ lifecycle, from drug discovery to the post-authorisation setting.
EMA - public consultation an ICH Reflection Paper on “Proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data
20th July 2023The European Medicines Agency has published for public consultation an ICH Reflection Paper on “Proposed 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”, co-authored by EMA, US FDA and Health Canada. This Reflection Paper builds on the 2022 statement from the International Coalition of Medicines Regulatory Authorities (ICMRA), offering a strategic approach for future ICH guidelines on the assessment of real-world data (RWD) and real-world evidence (RWE). It constitutes the first step towards international harmonisation of the following focus areas: Convergence on terminology for RWD and RWE Format for protocols and reports of study results based on RWD submitted to regulatory agencies throughout the lifecycle of medicines Registration of study protocols and reports EMA is coordinating the public consultation in Europe in parallel with a consultation run by ICH, to ensure European stakeholders have the opportunity to comment. Your input is crucial to help shape the future ICH guidelines that will address the complexity of use and impact of RWD/RWE in medicines regulation. Comments should be provided using this template and sent to ich@ema.europa.eu by 30 September 2023. For more details on this topic, please click here.
EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 2023
19th July 202311-13 July 2023
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3 - 6 July 2023
19th July 20233 - 6 July 2023
EMA - Phasing out of extraordinary COVID-19 regulatory flexibilities
19th July 2023EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This follows the end of the COVID-19 public health emergency declared by WHO in May 2023.
FDA - Roundup of Agency Events
19th July 202318th July 2023
MHRA - Lists of products using derogations under the European Commission Directive 2022/642 Updated
19th July 2023Lists of products using derogations under the European Commission Directive 2022/642
