Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Regulatory Updates
FDA guidance updates
- Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. On 25th July, the US Food & Drug Administration (FDA) published final guidance to provide sponsors and other interested parties with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision on the effectiveness or safety of a drug. Click to view source
- Providing Over-the-Counter Monograph Submissions in Electronic Format. On 25th July, the FDA announced the availability of a final guidance for industry entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This guidance is intended to assist submitters by describing the electronic over-the-counter (OTC) monograph submissions requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format. Click to view source
- CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients. On 25th July, draft guidance was published recommending the acceptable amounts for residual solvents in pharmaceuticals for the safety of the target animal as well as for the safety of residues in products derived from treated food-producing animals. The guidance recommends the use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. Click to view source
Health Canada issues notice on proposed changes to guidance on recognised standards for medical devices
On 25th July, Health Canada issued a notice on proposed changes to the guidance on recognised standards for medical devices. The agency is looking for feedback on the updates made to the list and guidance from medical device manufacturers, regulatory affairs representatives in medical devices and healthcare professionals. The consultation will run from 25th July until 23rd September 2024.
MHRA issues five essential summer tips for the safe use of medicines and medical devices
On 29th July, the Medicines and Healthcare products Regulatory Agency (MHRA) published five top summer tips for people taking medicines or using medical devices over the holiday season.
MHRA guidance updates
- International Recognition Procedure. On 30th July, the MHRA updated the International Recognition Procedure (IRP) lifecycle validation checklist in its guidance on how to use the procedure for medicines licensing applications. Click to view source
- Access Generic Medicines Work Sharing Initiative On 1st August, the Generic Medicines Work Sharing Initiative Operational Procedures (GMWSI) was updated. Click to view source
ICH M13A Guideline reaches Step 4 of the ICH Process
On 31st July, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced that the ICH M13A Guideline and associated Q&As on “Bioequivalence for Immediate-Release Solid Oral Dosage Forms” reached Step 4 of the ICH Process on 23rd of July 2024. It provides recommendations on conducting bioequivalence studies during both the development and post-approval phases for orally administered immediate-release solid oral dosage forms. The Q&A document is intended to provide additional clarification and improve the harmonisation of bioequivalence study design and data analysis.
ISPE releases second edition of GAMP Good Practice Guide on Validation and Compliance of Computerised Clinical Systems and Data
The International Society for Pharmaceutical Engineering (ISPE) has released the second edition of the GAMP Good Practice Guide on Validation and Compliance of Computerised Clinical Systems and Data. The guide has been significantly expanded to foster a robust validation framework to help support the integrity and efficiency of clinical trials.
Industry Updates
New gut microbiome atlas could offer better treatment for digestive disorders
On 24th July, King’s College London (KCL) announced its researchers have developed a new gut microbiome atlas in collaboration with MetaGenoPolis and the Science for Life Laboratory to help better understand how microorganisms in the gut impact disease. The research identifies gut bacteria appearing in individuals with 23 separate diseases across 19 countries.
HDR UK and DPUK granted £2m for new MND research initiative
On 25th July, it was announced that the Health Data Research UK (HDR UK) and Dementias Platforms UK (DPUK) have received £2m in funding to launch a new initiative to accelerate motor neurone disease (MND) research. Supported by the UK Dementia Research Institute, the MND Research Data Catalyst is funded by the Department of Health and Social Care and delivered through the National Institute of Health and Care Research (NIHR). It is part of wider support to grow MND research by the UK government in partnership with charities and organisations including the NIHR, UK Research and Innovation, MND Association, My Name’5 Doddie Foundation, MND Scotland, and LifeArc.
WHO launches initiative to develop mRNA Vaccines for H5N1 avian influenza
On 29th July, the World Health Organisation (WHO) announced the launch of an initiative to advance the development of mRNA vaccines against human avian influenza (H5N1). Led by Sinergium Biotech, the project aims to enhance pandemic preparedness by building vaccine production capacity in low- and middle-income countries (LMICs) through the mRNA Technology Transfer Programme, an initiative launched in July 2021 to build capacity in LMICs for the development and production of mRNA-based vaccines.
FDA opens vacancy for CDRH Director following Jeff Shuren’s retirement
On 30th July, the FDA officially opened the Center for Devices & Radiological Health (CDRH) Director vacancy following the retirement of former CDRH Director Jeff Shuren. The Center Director is responsible for fulfilling CDRH’s mission to protect and promote public health and to help ensure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
EMA backs pilot for joint African assessment procedures
On 30th July, the European Medicines Agency (EMA) announced it has awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative of the African Union Development Agency (AUDA-NEPAD) to support a pilot to assess procedures for the joint continental evaluation of medicines in Africa. The collaboration aims to enhance regulatory harmonisation across Africa, ensuring timely access to safe and effective medicines and will involve multiple African countries working together to assess and approve medicines collectively.
Biogen announces collaboration on blood-based biomarkers and test for tau pathology in Alzheimer’s disease
On 30th July, Biogen, Beckman Coulter, and Fujirebio announced a collaboration to potentially identify and develop blood-based biomarkers for tau pathology in Alzheimer’s disease. The partnership aims to create minimally invasive diagnostic tools that can stratify patients and monitor treatment responses, enhancing the development of tau-targeting therapies. The collaboration leverages Biogen’s expertise in biomarker research with Beckman Coulter’s and Fujirebio’s diagnostic development capabilities.
Issue Number: WN00173
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