Held 5-7 September 2023
EMA 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.
15 September 2023
Edition 173
Held 11-14 September 2023
The 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.
Guidance for IRBs and Clinical Investigators released September 2023
FDA releases guidance document
An at-a-glance summary of news from around the agency
Holly 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.
Launched 19th September 2023
The Innovative Devices Access Pathway (IDAP) pilot was launched on 19th September 2023.
Published 15th September 2023
A new regional centre to promote Yellow Card reporting has been launched in Belfast on 13th September 2023.
Being held on 23rd November 2023
EMA 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.
Meeting highlights
This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
August 2023
New guidance for industry
Released August 2023
An at-a-glance summary of news from around the agency,
TÜV 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.
The revised Annex 1 on “sterile manufacturing of the PIC/S GMP Guide entered into force on 25 August 2023 and has been published.
The 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.
EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a wider range of medicines.
EMA 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.
Edition 59, July 2023
HMA/EMA joint Big Data Steering Group
An at-a-glance summary of news from around the FDA.
Annual conflict of interest compliance report for 2022 added to the MHRA website.
The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.
In 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 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 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.
The 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.
11-13 July 2023
3 - 6 July 2023
EMA, 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.
18th July 2023
Lists of products using derogations under the European Commission Directive 2022/642
Health professionals and the public have until 15 August to share their views on the potential reclassification of codeine linctus to a prescription-only medicine.
MHRA 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.
The EMA is organising its first-ever EMA Veterinary Awareness Day to be held on 12 and 13 September 2023.
ACT EU initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU).
19-22 June 2023
An at-a-glance summary of news from around the agency:
This Reflection Paper was endorsed by the Assembly in June 2023.
Released 4th July 2023
Supplement 1 to Document Number 17 on Application of GLP Principles to Computerised Systems
World 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.
EMA publishes review of its studies
Report 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.
Public consultation on the transparency rules for the operation of the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS)
Issue 170, June 2023
Meeting Highlights
Meeting Highlights
Building 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®.
A roundup of FDA news
This 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.
The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.
Mr David Crundwell joined the Commission on Human Medicines on 12 June 2023 as a lay representative.
Countries 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.
The 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.
2022 Annual Report available to view
Vaccines 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).
CTIS newsflash – 9 June 2023
The European Medicines Agency has published for public consultation a “Draft ICH E6 (R3) guideline on good clinical practice – step 2b”.
13th June 13 2023
ICH E6(R3) Presentation now available
Bulgaria / BDA will become PIC/S’ 55th Participating Authority and Saudi Arabia / SFDA PIC/S 56th Participating Authority as from 1 July 2023.
A new PIC/S Deputy Chairperson and a new PIC/S Sub-Committee on Strategic Development (SCSD) Chair took office on 11 May 2023.
You are invited to comment on the below report.
The Windsor Framework sets out a long-term solution for the supply of medicines into Northern Ireland. These measures will commence on 1 January 2025.
On 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.
News, activities and interviews from the Veterinary Medicines Division. Published quarterly by the European Medicines Agency.
This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
Set 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.
MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners
Andrew Fisher, Lead Senior GCP Inspector, writes a blog about the recent changes.
CVMP opinions on veterinary medicinal products
This 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.
As 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.
The 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.
Today (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.
ICH-E6(R3): An Important Global Good Clinical Practice Standards - Available for Public Input.
EMA 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).
The 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.
This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
Edition 169
Highlights from 10 - 12 May 2023 meeting
News, views and interviews for the informed stakeholder. Published four times a year by the European Medicines Agency
EMA 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.
MHRA 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.
The 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.
5 May 2023
Scope, terms of participation and data submission process
EMA 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.
The newsletter for micro-, small- and medium-sized enterprises (SMEs),
On 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.
The 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.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.”
A write up of the event by Graham Carroll
The 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.
The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.
The 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.
Shiva Ramroop, discusses how we ensure the safety of vaccines for children in the UK.
Clarification of the requirements for the submission of audit reports
Held on 21-22 February 2023 - here is write up of the event.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023
This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
April 2023 issue of Clinical Trials Highlights.
Key information for patients, consumers and healthcare professionals.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023
On 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.
EMA 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).
This 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.
This version of the guidance replaces the version made available in July 2017. This revision of the guidance document updates hyperlinks, mailing, and contact information.
CDER’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
The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.
After almost 8 years as a Board Member, Stephen has decided to step down on 11 July 2023.
Instructions for integrating with the new production MORE platform API.
The World Health Organization (WHO) has appointed five new senior figures to its headquarters leadership team in Geneva.
A collection of frequently asked questions that have been submitted by the industry to the DI taskforce.
LinkedIn Live interview with Peter Arlett: Real-world evidence in medicines regulation, 20 April at 14:00-14:30 CET
Issue 168
View the meeting highlights.
EMA 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.
On 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.
The 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.
Since 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.
DARWIN 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.
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023
MHRA good clinical practice (GCP) metrics reports of compliance issues, 2019-2020
UKRI has published the first edition of its EDI strategy, which outlines our ambition for a thriving research and innovation system, by everyone, for everyone.
EMA 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.