If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
European countries have substantially reduced sales of veterinary antibiotics, which translates into a lower risk of bacteria becoming resistant in people and animals.
An at-a-glance summary of news from around the agency
MHRA 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.
IRP is expected to further help bringing life-saving new medicines to UK patients from 1 January 2024
Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments
MHRA performance - Assessment of New Marketing Authorisation Applications and Variations
World 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.
This 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.
Comments by 31st January 2024
10th November 2023
The 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.
This year marks the 10th anniversary of the International Coalition of Medicines Regulatory Authorities (ICMRA).
6-9 November 2023
7-9 November 2023
The FDA has published its final guidance on Benefit-Risk Assessment (BRA), which clarifies how these considerations factor into FDA's regulatory decisions.
The 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.
Dr 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.
Today, 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.
The 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.
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2023 meeting.
The scheme will see the lowest-risk clinical trials processed by the MHRA in less than 14 days.
A summary of the most recent EMA Committee for Veterinary Medicinal Products (CVMP) meeting.
EMA 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.
EMA Management Board: highlights of October 2023 meeting
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
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.
This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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 email@example.com 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
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.