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Recent News
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EMA - Consumption of antimicrobials in animals reaches lowest level ever in Europe
22nd November 2023European countries have substantially reduced sales of veterinary antibiotics, which translates into a lower risk of bacteria becoming resistant in people and animals.
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EMA - Small and Medium-Sized Enterprises Newsletter
22nd November 2023Issue 60
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FDA - FDA Roundup: 21 November, 2023
22nd November 2023An at-a-glance summary of news from around the agency
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MHRA - International Recognition Procedure Updates
22nd November 2023MHRA added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle to the International Recognition Procedure pages of it's website.
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MHRA - MHRA launches online Eligibility Checker tool for applications via the new International Recognition Procedure (IRP)
22nd November 2023IRP is expected to further help bringing life-saving new medicines to UK patients from 1 January 2024
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MHRA - Performance Metrics
22nd November 2023Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments
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MHRA - Performance Metrics January 2023 – October 2023: Assessment of New Marketing Authorisation Applications and Variations
22nd November 2023MHRA performance - Assessment of New Marketing Authorisation Applications and Variations
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MHRA Blog - Antimicrobial resistance: How we’re supporting innovative solutions to a looming global health emergency
22nd November 2023World AMR Awareness Week (WAAW) is an annual global campaign from 18-24 November that raises awareness and understanding of antimicrobial resistance (AMR), a global health issue worsened by the misuse of antimicrobial agents such as antibiotics.
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Swissmedic - Interpretation of Annex 1
22nd November 2023This technical interpretation focuses on some of the most important main changes of the revision 2022 of Annex 1 and also covers aspects that were already included in the previous version of this guideline and that repeatedly gave rise to questions.
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EMA - Veterinary Papers Released for Public Consultation
16th November 2023Comments by 31st January 2024
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023
13th November 2023Meeting highlights
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EMA - CTIS newsflash
13th November 202310th November 2023
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EMA - Call for expression of interest for independent scientific experts to participate in the work of EMA’s Safety Committee
13th November 2023The European Commission is launching a selection procedure to appoint independent scientific experts to EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Six experts will be appointed for a three-year mandate starting on 2 July 2024.
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EMA - Global regulators celebrate 10 years of strategic leadership and cooperation
13th November 2023This year marks the 10th anniversary of the International Coalition of Medicines Regulatory Authorities (ICMRA).
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EMA - Human Medicines Highlights Oct 2023
13th November 2023Issue 174
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
13th November 20236-9 November 2023
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)
13th November 20237-9 November 2023
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FDA - Benefit-Risk Assessment for New Drug and Biological Products
13th November 2023The FDA has published its final guidance on Benefit-Risk Assessment (BRA), which clarifies how these considerations factor into FDA's regulatory decisions.
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ICH - Assembly Meeting, Prague, Czech Republic, October/November 2023
13th November 2023The Assembly of the International Council for Harmonisation (ICH) met in-person on 31 October & 1 November 2023, in Prague, Czech Republic in parallel of meetings of 16 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
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MHRA Blog - The role of genetics in medicine safety
13th November 2023Dr Alison Cave, Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) highlights how genetics could play an important role in minimising the risk of adverse drug reactions (ADRs), and how the MHRA are working with partners across the system to make this a reality with their new Yellow Card biobank.
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FDA - Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
25th October 2023Today, FDA issued a draft guidance to inform industry about the agency’s continued use of remote interactive evaluations as an approach for evaluating drug facilities, as appropriate.
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MHRA and international partners publish five guiding principles for machine learning-enabled medical devices
24th October 2023The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have collaborated to identify five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs aim to remove the regulatory burden for developers of machine-learning-enabled medical devices (MLMDs), enabling reallocation of resources to improve product performance for patients.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2023
13th October 2023EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2023 meeting.
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MHRA - New streamlined notification scheme for lowest-risk clinical trials marks start of MHRA overhaul of regulation
12th October 2023The scheme will see the lowest-risk clinical trials processed by the MHRA in less than 14 days.
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 October 2023
6th October 2023A summary of the most recent EMA Committee for Veterinary Medicinal Products (CVMP) meeting.
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EMA - Revised transparency rules for the EU Clinical Trials Information System (CTIS)
6th October 2023EMA has adopted PDF icon revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System. The simplifications introduced will give access to clinical trial information to stakeholders including patients and healthcare professionals in a faster and more efficient way.
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EMA Management Board: highlights of October 2023 meeting
6th October 2023EMA Management Board: highlights of October 2023 meeting
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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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