Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Company Updates
Top tips for choosing the right QA consultancy
Is your organisation considering a QA consultancy? There are many reasons why your organisation may be in the market – including growing your services, staffing challenges or backlogs – and with no shortage of consultancies available, it can be challenging to find the right fit for your organisation and its goals. Here, we explore key considerations to bear in mind when choosing and committing to any QA consultancy.
For further information on how we can assist you, or if you have any questions, don’t hesitate to contact us at info@towermains.com.
Regulatory Updates
MHRA announces consultation on improved safety for high-risk in vitro diagnostic devices
On 21st May, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a four-week consultation which will support improved safety for certain high-risk in vitro diagnostic (IVD) devices. The new policy being consulted on would require manufacturers to comply with additional measures for certain IVDs, such as blood tests used to identify blood type before transfusions or tests which identify life-threatening diseases, introducing harmonised requirements for these products.
MHRA announces a proposed framework for international recognition of medical devices
On 21st May, the MHRA published a statement of policy intent for international recognition of medical devices. It describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the European Union, and the US depending on device type, class, and prior approval. It also focuses on ensuring safe access to quality-assured medical devices and reducing the duplication of assessments by comparable regulators to enable resources to be focused on more innovative products for the benefit of patient health. The agency continues to review the list of comparable regulator countries and is in active discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) to explore the recognition of medical device approvals from Japan.
Further MHRA updates
- Medical devices regulations: compliance and enforcement. On 17th May, the MHRA updated guidance to reflect changes to the legislation relating to MHRA’s investigatory and enforcement powers. Click to view source
Medical devices: new guidance for industry and notified bodies
On 21st May, the European Medicines Agency (EMA) announced the availability of newly revised guidance for applicants, marketing authorisation holders and notified bodies of medical devices. The question-and-answer document provides practical considerations on the implementation of medical devices and in vitro diagnostic regulations for combinations of medicinal products and medical devices. It has been provided to support the application of the regulations on medical devices (Regulation (EU) 2017/745) and on in vitro diagnostic devices (Regulation (EU) 2017/746).
FDA guidance updates
- Labelling requirements for new animal drugs. On 21st May, the US Food and Drug Administration (FDA) announced the extension of the comment period for the proposed rule entitled “Labelling Requirements for Approved or Conditionally Approved New Animal Drugs” by 60 days. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. The new deadline to submit comments is the 9th of August 2024. Click to view source
- CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Toxicity Testing (Revision 1). On 23rd May, draft guidance was published to provide guidance on the core recommendation for a multigeneration study for those veterinary medicinal products that leave residues in human food. Click to view source
Industry Updates
NIHR awards HealthTech Research Centre Network £5m to advance health innovations
On 16th May, the National Institute for Health and Care Research (NIHR) announced it has awarded £5 million for an NIHR HealthTech Research Centre Network (HRC), hosted by Sheffield Teaching Hospitals NHS Foundation Trust. The network will provide coordination and leadership for the HRCs, supporting the development, evaluation and adoption of innovative health and care technology to support people to live healthier, better-quality lives.
FDA Voices: FDA promotes clinical trial innovation
On 20th May, the FDA published the FDA Voices: “FDA Promotes Clinical Trial Innovation,” by Hilary Marston, MD, MPH, Chief Medical Officer and Kevin Bugin, PhD, Deputy Director of Operations in the Office of New Drugs, Center for Drug Evaluation and Research. As the FDA observed Clinical Trials Day, it reflected on the progress and widespread efforts underway to advance clinical trial innovation.
FDA announces formation of The OCE Equity Program
On 20th May, the FDA’s Oncology Center of Excellence (OCE) announced the formation of The OCE Equity Program. The program expands Project Equity, continuing the OCE’s work to improve access to clinical trials of oncology medical products for populations that have been historically underrepresented in clinical research. The OCE formed Project Equity in 2021 to focus the OCE’s longstanding efforts to address the well-documented underrepresentation of racial and ethnic subgroups in clinical trials.
European medicines network designated as WHO listed authority
On 20th May, the European Medicines Regulatory Network (EMRN) was designated as a WHO Listed Authority (WLA) by the World Health Organisation (WHO). This means that the network, composed of the European Commission, EMA and the 30 national authorities of the European Economic Area Member States, is recognised as meeting international regulatory standards, guidelines, and practices.
EMA launches fifth communication perception survey
On 21st May, the EMA launched its biennial communication perception survey. The purpose of the survey is to collect feedback on EMA’s external communications from patients, consumers, healthcare professionals, animal health professionals, academics, media, other regulators, and the pharmaceutical industry. The agency invites everyone to fill in the survey by Friday, 21 June 2024.
UK MRC and AstraZeneca partner for translational clinical research
On 22nd May, the Medical Research Council (MRC) announced its partnership with pharmaceutical company AstraZeneca to provide six MRC clinical fellows with industry placement opportunities for clinical research. This scheme aims to provide clinically active healthcare professionals currently funded by MRC the opportunity to embed within a major pharmaceutical company.
Issue Number: WN00163
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