Tower Mains Weekly Newsletter
Company Updates
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Regulatory Updates
MHRA publishes information on the MHRA / HRA Coordinated pathway
On 9th June, the Medicines and Healthcare products Regulatory Agency (MHRA) published information on its collaboration with the HRA to offer a new coordinated assessment pathway which will streamline the review of clinical investigations involving medical devices. This assessment pathway will benefit applicants by ensuring the MHRA review, and the Research Ethics Committee (REC) review are undertaken in parallel, and information will be shared.
Windsor Framework to commence in January 2025
On 9th June, the MHRA announced the Windsor Framework measurements are to commence on the 1st of January 2025. The framework sets out a long-term solution for the supply of medicines into Northern Ireland and will ensure that medicines can be approved and licensed on a UK-wide basis by the MHRA. This will enable medicines to use the same packaging and labelling across the UK, and as such, all medicines on the UK market will be labelled as for sale only within the UK.
MHRA guidance updates
- Advertising medicines. On 12th June, the MHRA published guidance on how to comply with the requirements for promoting medicines to the public and to prescribers and suppliers of medicines. Click to view source
- Software and AI as a Medical Device Change Programme. On 14th June, guidance on the MHRA’s ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI) was updated. Click to view source
ICH E6(R3) draft Guideline presentation available on the ICH website
On 13th June, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R3) Step 2 Informational Presentation developed by the Expert Working Group was published on the Efficacy Guidelines page. The EH(R3) introductory video is also available here.
FDA announces transition of over-the-counter medically important antimicrobials for animals to prescription status
On 12th June, the US Food and Drug Administration (FDA) announced the implementation of guidance for industry (GFI) #263, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter.” GFI #263 was introduced in a draft in 2019 and the final guidance was published in June 2021 and outlined a two-year timeline for animal drug sponsors to transition products to prescription status. The guidance contains information for sponsors of such new animal drugs to facilitate voluntary changes to the approved conditions of use of these drugs to prescription marketing status.
Industry News
EMA releases highlights from its latest Management Board meeting
On 9th June, the European Medicines Agency (EMA) published highlights from its latest Management Board meeting held on the 7th-8th June 2023. Highlights include the European Commission’s legal proposals to revise the pharmaceutical legislation, the agency’s recent activities on clinical trials and the revision of the mandates of the two main data governance groups of the European medicines regulatory network – the Network Data Board (NDB) and the Big Data Steering Group (BDSG).
MHRA Annual Review of GCP referrals
On 9th June, the MHRA published the 2020 annual review of Good clinical practice (GCP) referrals.
ARC program: Empowering rare disease stakeholders
On 13th June, the FDA published the FDA Voices: “Accelerating Rare disease Cures (ARC) Program Emerges as a Conduit for Empowering Rare Disease Stakeholders,” by Kerry Jo Lee, M.D., Associate Director for Rare Diseases, Rare Diseases Team, Division of Rare Diseases and Medical Devices, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs, Center for Drug Evaluation and Research. The ARC Program aims to increase the number of treatments by promoting innovative scientific design, providing a deeper understanding of regulatory policies, and engaging with patients, their advocates, and other rare disease stakeholders.
Novartis unveils results questioning the opinion that CML is a solved disease
On 9th June, Novartis announced the results from its Survey of Unmet Needs in chronic myeloid leukaemia (CML SUN), highlighting the requirement for increased communication and shared decision-making between patients and healthcare professionals, as well as more tolerable therapy options that do not sacrifice quality of life for efficacy. Final analyses of the data are expected to be published later in the year.
Valneva publishes chikungunya vaccine data
On 13th June, Valneva – a company focused on developing vaccines – announced critical Phase 3 data about its single-shot chikungunya vaccine, VLA1553 has been published in The Lancet, the world’s leading peer-reviewed medical journal. The data provides a detailed analysis of the Phase 3 results showing that VLA1553 demonstrated a very high seroresponse rate of 98.9% in participants 28 days after receiving the single administration and that the vaccine is VLA1553 is generally safe and equally well tolerated in younger and older adults.
Gilead to reveal pivotal liver disease research
On 14th June, Gilead Sciences, Inc. announced it will present real-world data on its efforts to advance WHO’s aim of eliminating viral hepatitis at the European Association for the Study of the Liver (EASL) Congress 2023. The data will include critical week 96 data from the company’s phase 3 study of Hepcludex, a drug that has been studied for levels of efficacy and safety while treating the hepatitis delta virus (HDV), and long-term results from ongoing studies of Vemlidy® (tenofovir alafenamide) in chronic hepatitis B (HBV). Ongoing research on liver fibrosis from nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) will also be presented.
Issue Number: WN00116
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