Company News
We are thrilled to announce that our Head of Quality Assurance, Shona Ross, and Head of Operations, Lianne Roeling, will be heading to Orlando, Florida for the upcoming Society of Quality Assurance 41st Annual Meeting!
Stay tuned for more updates in the coming weeks.
Regulatory News
MHRA confirms implementation of ICH E6(R3)
This month, the MHRA confirmed that ICH E6(R3) will be implemented on the same date as the revised UK clinical trial regulations. These regulations are expected to come into force approximately 12 months after they are finalised, likely around mid-2026.
IXCHIQ vaccine approved to protect adults against Chikungunya
On 4th February, the MHRA approved the IXCHIQ vaccine for use in adults to protect against chikungunya, a viral disease transmitted by mosquitoes. The vaccine, which contains a weakened form of the virus, helps the immune system develop antibodies to fight off the infection. The vaccine is given as a single dose and will be available via prescription.
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EMA establishes regular procedures for scientific advice on certain high-risk medical devices
On 10th February, the European Medicines Agency (EMA), in collaboration with the European Commission, introduced a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their clinical development strategy and clinical investigation proposals. Manufacturers of class III devices and class IIb active devices intended to administer or remove medicines can now submit requests for advice through a portal and consult with medical device expert panels at various stages of clinical development.
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MHRA hosts first Good Clinical and Laboratory Practice Symposia in five years
On the 11th and 12th of February, the MHRA hosted sessions on GCP and GLP, focusing on updates to UK Clinical Trials legislation and implementation plans. Topics included key changes in ICH GCP E6 R3 and its impact on UK trials, the MHRA’s implementation timeline, real-life case studies from recent GCP inspections, and compliance issues. There were also discussions on computerized systems, equipment in GLP studies, and laboratories involved in clinical trial sample analysis, with inspection findings shared to improve understanding of GLP and clinical labs. Tower Mains sent representatives to the sessions and will soon share their impressions and takeaways.
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Medical imaging agent gozetotide approved for diagnosis of prostate cancer
On 12th February, the MHRA approved gozetotide (brand name Illuccix) for use in prostate cancer diagnosis. This medical imaging agent binds to cancer cells with prostate-specific membrane antigen (PSMA), making them visible during PET scans. The approval followed clinical studies demonstrating its efficacy and safety, with common side effects including increased blood levels of digestive enzymes, constipation, and mild injection site warmth.
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Efanesoctocog Alfa approved by MHRA to treat haemophilia A.
On 14th February, the MHRA approved efanesoctocog alfa (brand name Altuvoct) for the treatment and prevention of bleeding in patients aged 2 years and older with severe or moderate haemophilia A. The approval was granted following an international recognition procedure and will be closely monitored for safety.
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MHRA performance data for assessment of clinical trials and established medicines
On 14th February, the MHRA published their performance data to January 2025, including timelines for applications for clinical trials, marketing authorisations for established and innovative medicines, and variations to existing approvals.
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Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients in the UK
On 17th February, the MHRA approved nemolizumab (brand name Nemluvio) for the treatment of moderate to severe prurigo nodularis in adults and moderate to severe atopic dermatitis (eczema) in adults and adolescents aged 12 and above. The approval follows a work-sharing initiative under the Access Consortium.
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European Commission launches consultation on electronic instructions for use
On 21st February, the European Commission launched a consultation seeking stakeholder input on a plan to allow electronic medical device instructions for use (eIFU) to be provided to healthcare providers for all devices, not just high-risk products. The consultation ends at midnight on 21st March 2025.
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New Leadership and a focus on Software
On 21st February, the MHRA released the February edition of the MedRegs blog, where Rob Reid discussed updates from the MHRA Innovative Devices team. These updates included changes in structure brought by the Innovation and Compliance group, which aims to drive innovation and regulatory excellence, ensuring medical devices are championed at the Executive and Board levels. Additionally, Marinos Ioannides joined the team as the new Head of Software and AI Medical Devices.
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Published Guidance
Medicines and Healthcare products Regulatory Agency (MHRA)
- 5th February: Decision tree for navigating nanotechnology-based products for medical application. The MHRA published guidance to support researchers and developers to understand how different guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and European regulatory agencies can be applied to support the development of nanomedicines.
- 17th February: Registration of in vitro diagnostic devices with expiring CE certificates. Guidance was issued to set out what the EU has extending the validity of certain Directive 98/79/EC on in vitro diagnostic (IVD) devices (EU IVDD) certificates and declarations means for registration and managing registered devices in the MHRA Device Online Registration System (DORS).
- 17th February: Registration of reusable or unclassified Class I devices and/or expiring CE certificates. This guidance outlines what the EU has extending the validity of certain Directive 93/42/EEC on medical devices (EU MDD) and Directive 90/385/EEC on active implantable medical devices (EU AIMDD) certificates means for registration and managing registered devices in the MHRA Device Online Registration System (DORS).
US Food and Drug Administration (FDA)
- 5th February: Institutional Review Board (IRB) Written Procedures. This guidance is for institutions and IRBs and is meant to assist staff at these institutions who are responsible for preparing and maintaining written procedures.
- 5th February: Institutional Review Boards Frequently Asked Questions. This information sheet is a compilation of answers to questions asked of FDA regarding the protection of human subjects of research and is for Institutional Review Boards and Clinical Investigators.
Updated Guidance
MHRA
- 6th February: Clinical trials for medicines: manage your authorisation, report safety issues. Updated the section of development safety update reports (DSURs) including a new user reference guide.
- 11th February: Category lists following implementation of the Windsor Framework. Updated the Category 1 list to include authorisations granted in December 2024.
- 11th February: Reporting to the National Supply Disruption Response (NSDR). Updated to promote earlier contact with the NSDR in a disruption response situation.
- 12th February: Importing investigational medical products into Great Britain from approved countries. Updated guidance document to take account of the EU implementation of the Clinical Trials Regulation No 536/2014 related to EU QP certification.
- 13th February: Safety Public Assessment Reports. Added Public Assessment Report for ‘Valproate: Managing reproductive risks in male patients under 55’
- 17th February: Regulating medical devices in the UK and Registering medical devices to place on the market . Updated to include guidance for the EU IVDR transition extension under Article 110 for the registration of IVD devices with the MHRA. Additionally, some minor updates to our current guidance for medical device registration, specifically for devices captured under the EU MDR transition extension under Article 120.
- February 19th: Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA. Guidance updated to reflect changes to UK legislation implementing new arrangements for medicines following the Windsor Framework and European Union Updates to GVP Module XVI and Addendum II, and to indicate requirements for Category 1 and Category 2 products following the implementation of the Windsor Framework.
- 20th February: Wholesalers & manufacturers guidance following agreement of the Windsor Framework. Guidance has been updated following agreement of the Windsor Framework to add Windsor Framework Wholesaler and Manufacturers Q&A and FMD Q&A
- 26th February: Implementation of medical devices future regime. Guidance has been updated to include information about the consultation response.
European Medicines Agency (EMA)
- 14th February: QRD Veterinary Product Information Template. This document has been updated throughout.
- 17th February: EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product Database Chapter 2. Following user experience and feedback, the chapter has been revised with the key changes including:
- Section 2.13.2 ‘Procedure type’: All Competent Authorities that are participating in the SPC harmonisation procedure must ensure that the selected reference medicinal products contain all mandatory data before the RMS creates the procedure in UPD. If any of these products is missing mandatory data, the creation of MRP will fail.
- Section 4.2 ‘Manufacturer’: Clarification on which term from RMS should be used if a substance has to be linked to the Manufacturer of the active substance.
- 18th February: Introductory guide: CTIS for SMEs and Academia. Minor updates have been made to wording in the Introduction sections relating to the transition period.
- 18th February: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure. Updates throughout, including that annotated product information files must include the statement containing the procedure number(s) and may be published on the EMA website as part of the product EPAR page, as well as an additional section on generic/hybrid/biosimilar products under Type IB Variations,
- 24th February: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications. Section 2.3. When and how Rapporteur and Co-Rapporteur appointed has been updated.
- 24th February: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. Section 2.4 regarding the procedure for the appointment of Rapporteurs/Co-rapporteurs and their assessment teams has been updated.
- 24th February: Marketing authorisation application (MAA) – pre-submission interactions form. This form has been updated.
Industry News
Prime Minister takes part in National HIV Testing Week
On 10th February, the Prime Minister participated in National HIV Testing Week by taking a public rapid HIV home test at No10 Downing Street. This historic moment marked him as the first serving British Prime Minister and G7 leader to take part in such an initiative; an initiative aimed at promoting the use of free, confidential HIV self-testing kits and aims to raise awareness about HIV prevention.
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UNESCO celebrates 10th anniversary of International Day of Women and Girls in Science
On 11th February, this year marked the 10th anniversary of the UNESCO International Day of Women and Girls in Science. The day aims to highlight the critical role women and girls play in the field of science and technology and seeks to promote gender equality in science by encouraging more young girls to pursue STEM (Science, Technology, Engineering, and Mathematics) careers.
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Professor Sir Ian Chapman appointed CEO of UKRI
On 25th February, the UK government announced the appointment of Professor Sir Ian Chapman as the new Chief Executive Officer (CEO) of UK Research and Innovation (UKRI), effective summer 2025. He will succeed Professor Dame Ottoline Leyser, who is stepping down after five years in the role. Currently the CEO of the UK Atomic Energy Authority, Sir Ian brings extensive experience in research leadership and fusion energy. His appointment is seen as a significant step forward for UKRI, reinforcing its mission to drive innovation and enhance lives through world-class research.
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Eli Lilly plans to more than double U.S. manufacturing investment since 2020 exceeding $50 billion
On 25th February, Eli Lilly announced plans to invest over $27 billion in constructing four new pharmaceutical manufacturing plants in the US. This investment aims to enhance domestic drug production and align with the U.S. administration’s push for increased manufacturing within the country. The new facilities are expected to create more than 3,000 skilled jobs and nearly 10,000 construction jobs, with operations projected to commence within five years. Three of the plants will focus on producing active pharmaceutical ingredients, while the fourth will manufacture sterile injectable medicines, including popular treatments for diabetes and weight loss.
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Syngenta acquires Novartis’ agricultural compound repository
On 26th February, Syngenta, a global leader in advancing biological products for agriculture, announced its acquisition of the Novartis collection of natural compounds and genetic strains for agricultural purposes. The deal, set to finalise by June 1st, will also involve Syngenta leasing Novartis’ fermentation pilot plant and scientific laboratories in Basel, Switzerland. However, Novartis will retain exclusive rights to the repository for pharmaceutical applications. Additionally, the transaction includes the transfer of Novartis’ Natural Products and Biomolecular Chemistry team to Syngenta.
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AstraZeneca therapy improves breast cancer survival in key trial
On 26th February, AstraZeneca announced that its investigational drug, camizestrant, has demonstrated a significant improvement in progression-free survival (PFS) for patients with advanced hormone receptor-positive (HR-positive), HER2-negative breast cancer.
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Fostering Growth: The Importance of Continuous Learning for QA Professionals
Today, continuous learning is more crucial than ever, particularly for Quality Assurance (QA) professionals. As industries advance and regulations evolve, staying up to date with the latest practices, technologies, and compliance standards is imperative.
In this article, written for the Research Quality Association (RQA)’s QUASAR February issue, Victoria Macleod highlights the critical role that ongoing professional development plays in keeping QA teams adaptable, proactive, and prepared for the challenges ahead. By focusing on continuous learning, QA professionals can stay ahead of regulatory changes, enhance their multidisciplinary skills, and foster a culture of growth.
Issue Number: WN00195
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