Company Updates
SQA 40th Annual Meeting
Exciting News! We are Exhibiting at SQA 40th Annual Meeting!
Our Head of Quality Assurance Shona Ross will be heading to Colorado for the upcoming #SQA2024 40th Annual Meeting in April.
Are you also attending? Come say Hi to Shona she will be at booth #205 If you’d like to connect and find out what Tower Mains can do for you, please feel free to reach out to us at info@towermains.com or contact Shona directly.
Regulatory Updates
MHRA Updates
Medicines That You Cannot Export from the UK or Hoard On 19th February, the Medicines and Healthcare products Regulatory Agency (MHRA) issued an updated guidance, Salbutamol was added to the list.
Latest Monthly Drug Safety Update Newsletter On 20th February, the MHRA published the latest monthly pdf edition of the Drug Safety Update newsletter in collaboration with its independent advisor, the Commission on Human Medicines.
Meeting Highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024
On 16th February, the European Medicines Agency (EMA) issued highlights from the meeting including:
- CVMP opinions on veterinary medicinal products
- Scientific advice
- Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
- Concept papers, guidelines- The Committee adopted an annex to the Guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water on compatibility studies between veterinary medicinal products and biocidal products (EMA/CVMP/QWP/592906/2022) following close of public consultation.
Non-inferiority and Equivalence Comparisons in Clinical Trials EMA Scientific Guideline
On 16th February, the EMA issued a draft concept paper for the development of a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials for public consultation 16/02/2024 to 31/05/2024. Specific issues related to non-inferiority and therapeutic equivalence comparisons require considerations different from those encountered in superiority trials, it was identified the need for a single guideline on non-inferiority and therapeutic equivalence comparisons which would facilitate the compilation of the related regulatory requirements.
UK Approved Bodies Launch Team-AB
On 19th of February, a group of approved bodies (AB) in the UK have come together to launch the UK Association for Medical Device Approved Bodies (Team-AB). It plans to lobby the government and the MHRA, as it develops new medical device regulations this year. The new body has launched with backing from 11 medical device certification bodies ranging from BSI Assurance to the UK arms of German equipment testing companies, TUV Rheinland and TÜV SÜD.
FDA Warns Industry About Potential Data Integrity Issues with Third-party Labs
On 20th February, the US Food and Drug Administration (FDA) issued a warning to sponsors of device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA.
There has been an increasing number of submissions that contain unreliable data generated by third-party labs and the FDA singled out Chinese and Indian entities in their statement. The FDA stated that in some cases, it has not been able to reach a substantial equivalence determination for products with data integrity issues and has been unable to give marketing authorization for those products.
ICH M10 Training Material
International Council for Harmonisation (ICH M10) “Bioanalytical Method Validation and Study Sample Analysis” training Material is now available on the ICH Website. The training slides include examples and questions and answers about specific aspects of the guideline.
Clinical Trials Information System Webinar: Last Year of Transition
The Clinical Trials Information System (CTIS) launched on 31st January 2022, from 31st January 2025 onwards sponsors will need to comply with their obligations under the CTR and its Delegated Acts.
This EMA is hosting a webinar on 25th March 2025 open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. Topics being covered include:
- Reflection on the implementation of the Clinical Trials Regulation;
- Reflection on transitional trials and how they are updated in CTIS;
- Update on the current status of CTIS.
Non-clinical and Clinical Evaluation of Antiviral Medicinal Products and Monoclonal Antibodies
On 22nd February 2024, the EMA issued a concept paper on the development of a guideline on the non-clinical and clinical evaluation of antiviral medicinal products and monoclonal antibodies for the prevention and treatment of COVID-19. This concept paper addresses the need to develop a guideline on the non-clinical and clinical evaluation of antiviral medicinal products and monoclonal antibodies intended for the treatment and/or prevention of coronavirus disease 2019 (COVID-19) for which there is currently no regulatory guideline in the European Union.
Industry Updates
FDA Approves First Cell Therapy for Solid Tumours
On 16th February, Iovance Biotherapeutics, a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte cell therapies for patients with cancer, FDA had approved AMTAGVI™ (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response.
Innovative Trials Unveil Retention Programme to Boost Clinical Trial Patient Retention in Paediatric Studies
On 19th February, Innovative Trials announced a new initiative designed to boost clinical trial patient retention in paediatric studies, in partnership with the Oliver Patch Project, a US charity.
The Retention Program is set up to engage directly with children and young people under the age of 18 years throughout their clinical trial experience. Created to be commissioned for any paediatric study worldwide, previous research suggests that engagement methods are associated with greater retention rates in paediatric clinical research. As part of this new programme children and teenagers will be collecting several patches throughout their clinical trial experience that can be ironed onto clothing so they can be worn like badges. Sponsors will be able to commission the programme to make further patches available to patients involved in their study, which will be delivered as retention items when they reach certain milestones throughout the study; only by remaining in the trial until the end can all patches be collected.
MHRA Update on Safety Review of Medicines Containing Pseudoephedrine
On 20th February, the MHRA published an update on the safety review of medicines containing pseudoephedrine. Pseudoephedrine is licensed for the symptomatic relief of nasal and sinus congestion in colds, flu, and allergies, it is orally taken for short term use. There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with pseudoephedrine.
The MHRA has reviewed the latest available evidence, including the assessment of cumulative reporting of adverse drug reaction reports, the safety information of all pseudoephedrine-containing medicines will be updated to provide clearer descriptions of these risks and potential risk factors for these conditions for both patients and healthcare professionals. Patients with very high blood pressure or hypertension not controlled by their medicines, or if they have severe acute or chronic disease or kidney failure should not take pseudoephedrine. If symptoms arise patients should stop taking pseudoephedrine immediately and seek urgent medical attention.
Multi-agency Report on Reduced Antibiotic Resistance
On 21st February, a joint report published by the European Centre for Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA), and the EMA, present data primarily collected between 2019 and 2021 on antibiotic consumption and antibiotic resistance in Europe. Data showed that E. coli bacteria in both animals and humans are becoming less resistant to antibiotics as the overall antibiotic consumption is reduced.
Issue Number: WN00150
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