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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)
20th September 2023Held 5-7 September 2023
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EMA - Accelerating clinical trials in the European Union (ACT EU) initiative website
20th September 2023EMA is pleased to inform you that a website has been launched for the Accelerating clinical trials in the European Union (ACT EU) initiative, co-led by the European Commission, the Heads of Medicines Agencies and the European Medicines Agency.
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EMA - CTIS newsflash
20th September 202315 September 2023
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EMA - Human Medicines Highlight Newsletter
20th September 2023Edition 173
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
20th September 2023Held 11-14 September 2023
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FDA - FDA Supports Innovation in Animal Biotechnology, Veterinary Products, Food for Animals Through New Comprehensive Agenda
20th September 2023The FDA announced it is taking new steps to further modernise its approach to evaluating and supporting the development of innovative animal and veterinary products, to increase regulatory flexibility, predictability and efficiency.
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FDA - Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products
20th September 2023Guidance for IRBs and Clinical Investigators released September 2023
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FDA - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
20th September 2023FDA releases guidance document
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FDA Roundup: 19th September 2023
20th September 2023An at-a-glance summary of news from around the agency
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MHRA - How nurses can support patient safety through reporting adverse incidents
20th September 2023Holly Coole, registered mental health nurse and senior manager for digital mental health at the MHRA, discusses how the safety of medical products is monitored and how all nurses can help ensure potential issues are picked up fast through the UK’s Yellow Card scheme.
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MHRA - The Innovative Devices Access Pathway (IDAP) Guidance
20th September 2023Launched 19th September 2023
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MHRA - UK patients set to have faster access to innovative medical technologies via new pathway
20th September 2023The Innovative Devices Access Pathway (IDAP) pilot was launched on 19th September 2023.
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MHRA - performance data for assessment of clinical trials and established medicines
20th September 2023Published 15th September 2023
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MHRA - Yellow Card centre launched in Northern Ireland to strengthen patient safety
13th September 2023A new regional centre to promote Yellow Card reporting has been launched in Belfast on 13th September 2023.
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EMA - 3rd Veterinary Big Data Stakeholder Forum
8th September 2023Being held on 23rd November 2023
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EMA - Survey on the Implementation of the CTR 536/2014
7th September 2023EMA are now launching a second EU survey aimed at collecting further views of sponsors and stakeholders on this updated regulatory and IT environment, identifying the remaining blocking issues, in order to plan and monitor their resolution.
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EMA - Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023
6th September 2023Meeting highlights
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EMA - CTIS newsflash, 1st Sept 2023
6th September 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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EMA - Human Medicines Highlights Issue 172
6th September 2023August 2023
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FDA - Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
6th September 2023New guidance for industry
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FDA Informed Consent - Guidance for IRBs, Clinical Investigators, and Sponsors
6th September 2023Released August 2023
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FDA Roundup: 1st September 2023
6th September 2023An at-a-glance summary of news from around the agency,
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MHRA - Three new UK Approved Bodies to certify medical devices announced by the MHRA
6th September 2023TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices in the UK.
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PIC/S - Entry into force of revised GMP Annex 1
6th September 2023The revised Annex 1 on “sterile manufacturing of the PIC/S GMP Guide entered into force on 25 August 2023 and has been published.
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MHRA- Guidance Released - International Recognition Procedure
31st August 2023The MHRA has created a new international recognition route for medicines utilising pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.
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EMA - OPEN framework extended to a wider range of medicines
2nd August 2023EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a wider range of medicines.
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EMA - Paving the way towards coordinated clinical trials in public health emergencies in the EU
2nd August 2023EMA has published a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set up and conducted in the European Union (EU) during public health emergencies.
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EMA - Small and Medium Enterprise Newsletter July 23
2nd August 2023Edition 59, July 2023
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EMA/HMA - Big Data Workplan 2023-2025
2nd August 2023HMA/EMA joint Big Data Steering Group
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FDA - Roundup: 1st August 2023
2nd August 2023An at-a-glance summary of news from around the FDA.
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MHRA - Annual conflict of interest compliance report for 2022
2nd August 2023Annual conflict of interest compliance report for 2022 added to the MHRA website.
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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.
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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.
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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.
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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.
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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.
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 2023
19th July 202311-13 July 2023
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3 - 6 July 2023
19th July 20233 - 6 July 2023
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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.
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FDA - Roundup of Agency Events
19th July 202318th July 2023
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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
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MHRA - MHRA launches public consultation on reclassification of opioid-containing cough medicine
19th July 2023Health professionals and the public have until 15 August to share their views on the potential reclassification of codeine linctus to a prescription-only medicine.
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MHRA - Thousands of unlicensed medical products seized in morning of raids in Bolton
19th July 2023MHRA Criminal Enforcement Unit (CEU) seized a quantity of suspected unlicensed medical products following coordinated raids at three residential and six business premises in Bolton, Greater Manchester.
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EMA - Veterinary Awareness Day
10th July 2023The EMA is organising its first-ever EMA Veterinary Awareness Day to be held on 12 and 13 September 2023.
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EMA - ACT EU: creating a better environment for clinical trials through collaboration
5th July 2023ACT EU initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU).
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
5th July 202319-22 June 2023
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FDA Roundup - 30th June 2023
5th July 2023An at-a-glance summary of news from around the agency:
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ICH - Reflection Paper on Harmonisation of RWE Terminology available for public consultation
5th July 2023This Reflection Paper was endorsed by the Assembly in June 2023.
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MHRA - Corporate Plan 2023 to 2026
5th July 2023Released 4th July 2023
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OECD - Advisory Document on GLP & Cloud Computing
5th July 2023Supplement 1 to Document Number 17 on Application of GLP Principles to Computerised Systems
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WHO - New collaboration between WHO International Classification of Diseases and MedDRA launched
5th July 2023World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are announcing a new collaboration to enhance registry and sharing of regulatory information on medical products worldwide.
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EMA - Use of real-world evidence in regulatory decision making
4th July 2023EMA publishes review of its studies
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EMA - Report on pharmacovigilance tasks From EU Member States
22nd June 2023Report published 22nd June 2023 Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders involved were key factors to allow the European medicines regulatory network to effectively respond to the pandemic. These activities are detailed in a report published today.
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EMA - Public Consultation - CTR and CTIS
21st June 2023Public consultation on the transparency rules for the operation of the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS)
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EMA - Human Medicines Highlights Issue 170
20th June 2023Issue 170, June 2023
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 June 2023
20th June 2023Meeting Highlights
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 - 8 June 2023
20th June 2023Meeting Highlights
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EMA - workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use
20th June 2023Building upon the experience of the submission of real-world evidence for regulatory purpose and the conclusions of previous activities around data standardisation, metadata, data quality and DARWIN EU®.
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FDA - FDA Roundup: 16 June, 2023
20th June 2023A roundup of FDA news
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FDA - Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry
20th June 2023This guidance provides information to sponsors and nonclinical laboratories regarding the use and management of whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice (GLP)-compliant nonclinical toxicology studies using non-human specimens.
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MHRA - Implementation of medical devices future regime
20th June 2023The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.
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MHRA - New lay commissioner appointed to the Commission on Human Medicines
20th June 2023Mr David Crundwell joined the Commission on Human Medicines on 12 June 2023 as a lay representative.
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WHO - Countries set out way forward for continued negotiations on global agreement on pandemic prevention, preparedness, and response
20th June 2023Countries of the World Health Organization (WHO) have moved forward negotiations on a global accord on pandemic prevention, preparedness and response, with a view to presenting a draft accord to the World Health Assembly in May 2024.
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MHRA - MHRA issues new guidance on the use of life saving adrenaline auto-injectors
19th June 2023The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. This new guidance includes an easy step-by-step guide on what to do in an emergency and provides updated advice on body positioning.
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EDQM - 2022 Highlights – EDQM annual report now available
14th June 20232022 Annual Report available to view
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EDQM - Ph. Eur. Commission keeps pace with veterinary vaccine development efforts
14th June 2023Vaccines for veterinary use (0062), Evaluation of safety of veterinary vaccines and immunosera (5.2.6) and Evaluation of efficacy of veterinary vaccines and immunosera (5.2.7).
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EMA - CTIS Newsflash, June 2023
14th June 2023CTIS newsflash – 9 June 2023
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EMA - Draft ICH E6 (R3) guideline on good clinical practice – step 2b
14th June 2023The European Medicines Agency has published for public consultation a “Draft ICH E6 (R3) guideline on good clinical practice – step 2b”.
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FDA - FDA Roundup published, June 2023
14th June 202313th June 13 2023
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ICH - The ICH E6(R3) draft Guideline presentation available now on the ICH website
14th June 2023ICH E6(R3) Presentation now available
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PIC/S - Bulgaria / BDA and Saudi Arabia / SFDA join
14th June 2023Bulgaria / BDA will become PIC/S’ 55th Participating Authority and Saudi Arabia / SFDA PIC/S 56th Participating Authority as from 1 July 2023.
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PIC/S - Changes to the PIC/S Executive Bureau
14th June 2023A new PIC/S Deputy Chairperson and a new PIC/S Sub-Committee on Strategic Development (SCSD) Chair took office on 11 May 2023.
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CIOMS - Real-world data and real-world evidence in regulatory decision making
12th June 2023You are invited to comment on the below report.
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MHRA - Windsor Framework medicines announcement
11th June 2023The Windsor Framework sets out a long-term solution for the supply of medicines into Northern Ireland. These measures will commence on 1 January 2025.
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EMA - Progress with EU-US mutual recognition agreement for inspections for veterinary medicines
7th June 2023On 31 May 2023, the European Union and the United States have made important progress towards enabling mutual recognition of inspections of manufacturing facilities of certain veterinary products.
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EMA - Veterinary Medicines Highlights Newsletter
7th June 2023News, activities and interviews from the Veterinary Medicines Division. Published quarterly by the European Medicines Agency.
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EMA - CTIS Newsflash -26 May 23
31st May 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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MHRA - New regulatory pathway set to support safe patient access to innovative medical technologies
31st May 2023Set for launch later in 2023, the Innovative Devices Access Pathway (IDAP) will be run by the MHRA, NICE, and other partners, including the devolved administrations.
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MHRA - new recognition routes
31st May 2023MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners
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MHRA - changes to the ICH E6 GCP Guideline
29th May 2023Andrew Fisher, Lead Senior GCP Inspector, writes a blog about the recent changes.
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 2023
25th May 2023CVMP opinions on veterinary medicinal products
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FDA - Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Guidance for Industry
25th May 2023This guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug2 development programs. This guidance provides recommendations for the use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to both superiority trials and noninferiority trials.
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FDA - Discussion Paper: Artificial Intelligence in Drug Manufacturing
25th May 2023As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, the Agency has identified in this discussion paper areas for which public feedback would be valuable.
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FDA - Guidance Snapshots/Podcasts highlight the agency’s commitment to improve the diversity of participants in clinical trials
25th May 2023The FDA have published two Guidance Snapshots accompanied by two Guidance Recap Podcasts to highlight the agency’s commitment to improve the diversity of participants in clinical trials, and to increase awareness of the agency’s 2020 guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, which presents recommendations sponsors can apply to diversify participation in clinical trials.
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WHO - WHO issues urgent call for global climate action to create resilient and sustainable health systems
25th May 2023Today (24th May) at the World Health Organization (WHO), panelists made an impassioned plea for urgent climate action as it hosted a Strategic Roundtable on the Role of the Health Communities in Climate Action: taking stock and moving forward at the World Health Assembly.
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ICH - ICH E6(R3) Principles, Annex 1 and Annex 2
23rd May 2023ICH-E6(R3): An Important Global Good Clinical Practice Standards - Available for Public Input.
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EMA - Annual report 2022 published
17th May 2023EMA published its annual report 2022 on 15th May 2023. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU).
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EMA - 3-year work plan for the Quality domain
17th May 2023The GMDP IWG 3-year workplan is developed with a focus on the Network Strategy and Regulatory Science Strategy (RSS) goals, with a particular emphasis on supply chain integrity and resilience, product quality and the impact of new manufacturing technologies on the supply chain.
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EMA - CTIS newsflash – 12 May 2023
17th May 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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EMA - Human Medicines Highlights Newsletter 169
17th May 2023Edition 169
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023
17th May 2023Highlights from 10 - 12 May 2023 meeting
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EMA - eAF-PMS NEWSLETTER 3
17th May 2023News, views and interviews for the informed stakeholder. Published four times a year by the European Medicines Agency
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EMA - recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact
17th May 2023EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact. Medicine shortages are a global health problem and are increasingly affecting European countries. Shortages can lead to medicine rationing and delay in critical treatments, with a significant impact on patient care. In addition, patients may need to use less effective alternatives and face an increased risk of medication errors. Ensuring the availability of authorised medicines in the European Union (EU) is a key priority for EMA and the European medicines regulatory network.
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MHRA - Medical device stand-alone software including apps
17th May 2023MHRA have updated 'Medical device stand-alone software including apps' to include information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance.
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WHO - calling for caution to be exercised in using artificial intelligence (AI) generated large language model tools (LLMs)
17th May 2023The World Health Organization (WHO) is calling for caution to be exercised in using artificial intelligence (AI) generated large language model tools (LLMs) to protect and promote human well-being, human safety, and autonomy, and preserve public health.
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EMA - CTIS newsflash
10th May 20235 May 2023
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EMA - Questions and Answers about the raw data proof-of-concept pilot for industry
10th May 2023Scope, terms of participation and data submission process
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EMA - Review of transparency rules for the EU Clinical Trials Information System (CTIS)
10th May 2023EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to send their comments via an online form by midnight (CET) on 28 June 2023.
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EMA - SME Office Newsletter 58
10th May 2023The newsletter for micro-, small- and medium-sized enterprises (SMEs),
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EMA - Statement from Emer Cooke on the end of the COVID-19 public health emergency
10th May 2023On Friday, the WHO Director General declared an end to the Public Health Emergency of International Concern (PHEIC) for the disease caused by the coronavirus SARS-CoV-2. I welcome this important milestone and would like to share some thoughts about what this means for EMA.
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FDA - Additional Steps to Advance Decentralised Clinical Trials
10th May 2023The agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research.
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FDA - Q9(R1) Quality Risk Management
10th May 2023The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.”
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MHRA - Good Manufacturing Practice Symposium 2023
10th May 2023A write up of the event by Graham Carroll
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MHRA - ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation
10th May 2023The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These are anticipated to reach Step 2 soon and will be available for public consultation.
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MHRA - Implementation of the Future Regulations
10th May 2023The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.
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MHRA - Publication Scheme
10th May 2023The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to making transparency and accountability to the public a fundamental principle of how we do business.
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MHRA Blog - Ensuring Child Vaccine Safety at Every Step
10th May 2023Shiva Ramroop, discusses how we ensure the safety of vaccines for children in the UK.
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Swissmedic - Changes to the guidance document GMP compliance by foreign manufacturers and the form Declaration by the Responsible Person for foreign manufacturers
10th May 2023Clarification of the requirements for the submission of audit reports
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MHRA - Good Distribution Practice Symposium 2023
2nd May 2023Held on 21-22 February 2023 - here is write up of the event.
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EMA - CHMP Highlights 24 - 26 April 2023
27th April 2023Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023
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EMA - CVMP Meeting Highlights 18-20 April 2023
26th April 2023Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023
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EMA - CTIS newsflash – 21 April 2023
26th April 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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EMA - Clinical Trials Highlights 14
26th April 2023April 2023 issue of Clinical Trials Highlights.
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EMA - Human Medicines Highlights Newsletter 168
26th April 2023Key information for patients, consumers and healthcare professionals.
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EMA - PRAC 11-14 April 2023
26th April 2023Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023
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EMA - Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines
26th April 2023On 8 December 2022, EMA’s veterinary medicines committee, the CVMP, recommended new measures to reduce the risks from exposure to the excipient N-methyl pyrrolidone (NMP) for women who may handle NMP-containing veterinary medicines and animals that are given these medicines.
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EMA - Single-arm trials as pivotal evidence for the authorisation of medicines in the EU
26th April 2023EMA has opened a public consultation on a PDF icon reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the European Union (EU).
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FDA - A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers
26th April 2023This 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.
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FDA - Final Guidance on Animal Drug User Fees and Fee Waivers and Reductions
26th April 2023This version of the guidance replaces the version made available in July 2017. This revision of the guidance document updates hyperlinks, mailing, and contact information.
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FDA - The Office of New Drugs' Efforts to Expand Regulatory Science Research
26th April 2023CDER’s Office of New Drugs (OND) developed a research program in 2018 to centralise and enhance its regulatory science research activities. Recently, the OND Research Program (OND-RP) published its first two fiscal year annual reports
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MHRA - Access Consortium: joint pipeline meetings
26th April 2023The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.
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MHRA - Chair Stephen Lightfoot Standing Down
26th April 2023After almost 8 years as a Board Member, Stephen has decided to step down on 11 July 2023.
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MHRA - MORE platform API (Application Programming Interface) set up - user reference guide
26th April 2023Instructions for integrating with the new production MORE platform API.
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WHO - Key leadership appointments made to drive WHO strategic direction and initiatives
26th April 2023The World Health Organization (WHO) has appointed five new senior figures to its headquarters leadership team in Geneva.
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APIC - Data Integrity FAQs
19th April 2023A collection of frequently asked questions that have been submitted by the industry to the DI taskforce.
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EMA - Interview with Peter Arlett
19th April 2023LinkedIn Live interview with Peter Arlett: Real-world evidence in medicines regulation, 20 April at 14:00-14:30 CET
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EMA - Human Medicines Highlights Issue April 2023
12th April 2023Issue 168
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023
12th April 2023View the meeting highlights.
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EMA - New features further strengthen PRIority Medicines scheme (PRIME)
12th April 2023EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of unmet medical needs.
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MHRA Blog - Happy 75th Anniversary to the World Health Organization
12th April 2023On 6th April 1948, the United Nations (UN) came together to establish a global organisation that promotes health, keeps the world safe, and serves the vulnerable. Seven decades later, the World Health Organization (WHO) is celebrating its 75th anniversary.
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ECA - New Guide on GMP Compliant Equipment Design
5th April 2023The purpose of this Guide is to illustrate the generally applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made.
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ICH - Q9 QRM Revision reaches step 4
5th April 2023Since 2005, the ICH Q9 Guideline on Quality Risk Management has represented the state of the art. A revision was announced at the end of 2020. In January, this revision has reached stage 4 and is now moving into implementation.
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EMA - DARWIN EU® has completed its first studies and is calling for new data partners
29th March 2023DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded. The network also initiated its first four studies using real-world data (RWD) from across Europe to better understand diseases, populations and the uses and effects of medicines.
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023
29th March 2023Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023
29th March 2023Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023
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MHRA - MHRA good clinical practice (GCP) metrics reports
29th March 2023MHRA good clinical practice (GCP) metrics reports of compliance issues, 2019-2020
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UKRI - equality, diversity and inclusion strategy
29th March 2023UKRI has published the first edition of its EDI strategy, which outlines our ambition for a thriving research and innovation system, by everyone, for everyone.
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EMA - Mid-point Report Published
27th March 2023EMA has published a report summarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas.
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