Tower Mains Weekly Newsletter
Regulatory Updates
FDA issues guidance for sponsors in the clinical development of drugs for the treatment of mpox
On 19th January, the US Food and Drug Administration (FDA) published draft guidance intended to support sponsors in their development of drugs for mpox. The guidance provides non-clinical, virology, and clinical considerations for mpox drug development programs, with a focus on recommendations to support the initiation of clinical trials.
FDA issues final guidance detailing its priorities regarding compounding of certain ibuprofen oral suspension
On 21st January, the FDA published immediately-in-effect final guidance describing the agency’s regulatory and enforcement priorities concerning the compounding of certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.
Clinical Trials: EU survey on the implementation of the Clinical Trial Regulation
On 23rd January, the European Commission published the EU survey on the implementation of the Clinical Trial Regulation (CTR). The survey was launched in July 2022 to collect feedback from sponsors and stakeholders to understand the overarching hurdles that hamper a smooth implementation of the CTR and capture how clear the requirements of the CTR are to the stakeholders. 62 sponsors and other stakeholders provided views on the new regulatory environment provided by the CTR and their experience with CTIS.
MHRA guidance updates
- On 23rd January, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on supplying authorised medicines from Great Britain to Northern Ireland. Click to view source
- On 25th January, the MHRA published guidance detailing the objectives and the operations of the Access Consortium – Generic Medicines Working Group (GMWG). Click to view source
Industry Updates
Assessment of human dietary exposure of people to residues of veterinary medicines in the EU
On 12th January, the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) announced the publication of a joint report on the development of a harmonised approach to the assessment of dietary exposure of people to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU.
MHRA increases UK assessment capacity for in-vitro diagnostic devices
On 18th January, the MHRA confirmed that UL International UK Ltd is now designated to assess almost all Part IV In-vitro Diagnostics Medical Devices, increasing the UK’s capacity to process conformity assessments and ensure safe and effective IVDs reach the UK public. Manufacturers of self-test IVDs and those for specific high-risk tests must apply to a UK-approved body for UKCA certification.
MSSG issues joint statement on shortages of antibiotic medicines in EU
On 20th January, the EMA, the European Commission, and the Heads of Medicines Agencies (HMA) announced that, through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), they are closely monitoring and responding to shortages of antibiotics affecting the EU. The agencies are cooperating closely to investigate whether additional measures could be undertaken to mitigate the impact of these shortages.
FDA clears TidePool app for use with compatible devices for automated insulin dosing
On 20th January, the FDA cleared for marketing the Tidepool Loop, a mobile application intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons six years of age and older. The Tidepool app is a prescription-only device for single-patient use that works with integrated continuous glucose monitors (iCGMs) and alternate controller-enabled pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values.
European Commission Decision Reliance Procedure extension
On 24th January, the MHRA announced that the European Commission Decision Reliance Procedure (ECDRP) has been extended to 31th December 2023. Before this date, where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, ECDRP Marketing Authorisation Application (MAA) or variations can continue to be submitted to MHRA. From 1st January 2024, a new international recognition framework will be in place.
UK to introduce an innovative framework for POC manufacturing
On 25th January, the MHRA announced that the UK will be the first country to introduce a tailored framework for the regulation of innovative products manufactured at the point where a patient receives care. This follows a public consultation carried out by the MHRA, which heard from a range of individuals and organisations across the UK and internationally who highlighted the urgent need to establish a regulatory framework for these vital and varied products.
MHRA publishes its latest monthly Drug Safety Update
On 25th January, the MHRA published the January issue of its monthly Drug Safety Update newsletter from the agency and its independent advisor the Commission on Human Medicines (CHM).
Click to view source View PDF Newsletter
STORM Therapeutics presents STC-15 data for patients with acute myeloid leukaemia
On 25th January, STORM Therapeutics Ltd, a clinical-stage biotechnology company discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases, presented new data on its lead candidate, the oral METTL3 inhibitor STC-15. The data demonstrates that the STC-15 exhibits efficacy as a single agent and in combination with venetoclax using patient-derived tumour models.
Enhertu approved as first HER2-directed therapy for patients with HER2-low metastatic breast cancer in EU
On 26th January, it was announced that AstraZeneca and Daiichi Sankyo’s Enhertu, a specifically engineered HER2-directed antibody-drug conjugate (ADC), has been approved in the EU for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
ICH uploads documents to its website
On 26th January, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) added the Continuous Manufacturing of Drug Substances and Drug products and the ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms presentation to its website.
Issue Number: WN00096
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