Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Regulatory Updates
Statutory Instrument laid in Parliament outlines measures for implementing Medical Device Regulatory Reform and improving patient safety
On 21st October, the draft Post-market Surveillance (PMS) Statutory instrument (SI) statutory instrument was introduced to Parliament, outlining initial steps in delivering Medical Device Regulatory Reform and strengthening patient safety. Developed by the Medicines and Healthcare products Regulatory Agency (MHRA), these measures aim to enhance patient safety by requiring manufacturers to improve post-market surveillance and take corrective actions more swiftly. The reforms follow recommendations from the Independent Medicines and Medical Devices Safety Review and will align UK regulations more closely with international approaches. The legislation is expected to come into force by summer 2025, with further guidance to be provided.
MHRA consultation on statutory fees ends on 24th October 2024
On 24th October 2024, the MHRA consultation seeking views on proposals to update its statutory fees to ensure they continue to recover their costs will end. The implementation date for these proposed changes is April 2025.
MHRA guidance updates
- Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice. On 24th October, the MHRA updated guidance and information on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice. Click to view source
World Medical Association releases the latest amendments to the Declaration of Helsinki
On 22nd October, the World Medical Association released the latest amendments to the Declaration of Helsinki, a cornerstone document outlining ethical principles for medical research involving human participants, including research using identifiable human material or data. Adopted initially in 1964, the Declaration continues to evolve to reflect the dynamic landscape of medical research and the need for robust ethical standards. This latest amendment, adopted at the 75th WMA General Assembly in Helsinki, Finland, in October 2024, underscores a continued commitment to ethical medical research and safeguarding human participants in medical studies.
ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video now available
On 24th October, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced the publication of ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video. The video aims to support stakeholders in understanding the revisions made to the guideline, focusing on study quality, design, and data reliability.
FDA guidance updates
- Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development. On 17th October, the Food and Drug Administration (FDA) published final guidance to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of drug interaction (DI) information in labelling as described in the regulations for the content and format of labelling for human prescription drug and biological products.
- Drug Interaction Information in Human Prescription Drug and Biological Product Labelling. On 21st October, draft guidance was issued to provide a framework for considering whether and what type of long-term neurologic, sensory and developmental evaluations could be useful to support a determination of safety of a drug, biological product, or device for use in neonates, and if so, which domains of neurodevelopment may be most applicable.
Industry Updates
FDA highlights on Nitrosamine research
On 17th October, the FDA published a Spotlight on Center for Drug Evaluation and Research (CDER) Science featuring the evaluation of pH adjustment and addition of antioxidants in tablet formulations using bumetanide (BMT) as a model drug product to mitigate the formation of N-nitrosobumetanide (NBMT). NBMT is a known nitrosamine drug substance-related impurity (NDSRI) that may form in BMT. This research helped support CDER’s Control of Nitrosamine Impurities in Human Drugs guidance by providing manufacturers with potential approaches to drug formulation to mitigate or prevent formation of NDSRIs in solid state (tablet) drug products.
EMA re-confirms non-renewal of authorisation of Duchenne muscular dystrophy medicine
On 18th October, the European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) has confirmed its previous recommendation to not renew the conditional marketing authorisation for Translarna (ataluren). This last round of assessment concluded that the effectiveness of Translarna has not been confirmed.
Calluna Pharma completes successful phase 1 trial of first-in-class fibrotic disease drug
On 23rd October, Calluna Pharma, a clinical stage biotechnology company, announced the completion of Phase 1 clinical study for CAL101, a first-in-class monoclonal antibody (mAb) targeting fibrotic and fibro-inflammatory diseases. The study, conducted at the Medicines Evaluation Unit in Manchester, showed CAL101 to have a favourable safety, pharmacokinetic (PK) and immunogenicity profile. This trial included 57 subjects in a randomised, double-blind, placebo-controlled format, testing both single and multiple ascending doses.
Darzalex subcutaneous regimen approved by European Commission
On 23rd October, Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission has approved the subcutaneous (SC) formulation of DARZALEX (daratumumab) in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). This approval allows patients to receive this quadruplet therapy at initial diagnosis, providing a new treatment that has shown significant improvements in outcomes.
MHRA highlights work in training multiple WHO polio laboratories around the world
On 24th October, World Polio Day, the MHRA highlighted its efforts in training multiple World Health Organisation (WHO) laboratories worldwide on advanced molecular detection of polio using Direct Detection by Nanopore Sequencing (DDNS). This method reduces detection times by half, speeding up outbreak responses and supporting global eradication efforts. In collaboration with Imperial College London, the University of Edinburgh, Biosurv International and funded by the Bill and Melinda Gates Foundation, the agency has trained 25 countries in just over one year, crucial for early detection, saving public health authorities crucial time and money.
Issue Number: WN00185
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