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Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation
The Data Analysis and Real World Interrogation Network DARWIN EU seeks ten new data partners in 2024.
Edition 178, March 2024
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)
Released March 2024
An at-a-glance summary of news from around the agency.
The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review
March Edition
EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one for RWD studies.
Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024
Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria.
View the streams from last week's FDA, MHRA, Health Canada Symposium
Available now on the ICH website The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.
Dame June Raine, MHRA's Chief Executive, will be stepping down in the Autumn following five years in the role
Process changes from 1 March 2024 build on measures already implemented by the agency
EMA consultations open for comment now.
GMP for API
Draft guidance, Released January 2024.
Draft guidance, Feb 2024.
Med Tech Regulatory Reform: The first steps towards a new framework for medical devices in the UK
28 February 2024
Phase I period for public consultation now open.
EMA will harness its unique experience in coordinating intra-regional medicines regulation to support the strengthening of the African regulatory network. EMA has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors.
EMA has just launched the new Antimicrobial Sales and Use (ASU) Platform to support the collection of data by Member States on the sales and use of antimicrobials in animals.
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.
On 24 January 2024 EMA published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.
CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products Draft released and open for comments.
An at-a-glance summary of news from around the agency
Guidance updates on to how to notify the MHRA of changes to the PV System
The revised Schedule M prescribes the Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products; official says this will ensure Indian guidelines are at par with global standards.
Annex 1: Manufacture of sterile medicinal products
MHRA announces two new UK Approved Bodies to certify medical devices
The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector.
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-17 January 2024
An at-a-glance summary of news from around the agency.
In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the innovation they represent.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024
An at-a-glance summary of news from around the agency.
Released 9th January 2024
1st Jan 2023 to 31st Dec 2023
13th - 15th February 2024
U.S. Food and Drug Administration have authorised Florida’s Agency for Health Care Administration’s drug importation programme under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
MHRA sets out new plans to protect patient safety and enable access without delay for UK patients to innovative medical technologies.
This Q&A provides medicine developers with guidance on how to address challenges associated with expedited product development, so that robust quality and manufacturing data packages will be available to support their application.
EMA are pleased to inform you that the final version of the HMA-EMA Big Data Steering Group's Multi-annual Artificial Intelligence Workplan 2023-2028 has been published.
This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
Nov-Dec 23
Validity Period Extended
Applications are now open for academic institutions wishing to bid for funding to collaborate with others to establish new Regulatory Science and Innovation Networks (RSINs) in innovative sectors.
EMA releases first version of their Data Quality Framework for EU Medicines Regulation.
A joint report issued by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) reviews the Network’s response and highlights the main learnings for any future health crises.
The EMA has issued their implementation strategy for ICH M10 – public consultation is open until until 31 January 2024.
An at-a-glance summary of news from around the agency,.
European countries have substantially reduced sales of veterinary antibiotics, which translates into a lower risk of bacteria becoming resistant in people and animals.
Issue 60
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
Meeting highlights
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).
Issue 174
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
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.