The World Health Organization (WHO) has formed its Civil Society Task Force on Antimicrobial Resistance (AMR). The body supports and strengthens the WHO’s engagement with nongovernmental organisations, including civil society groups globally. It aims to foster collaborations, build capacity and amplify the voices of affected communities in the fight against AMR.
The mission of the Task Force is to ensure that civil society groups can effectively contribute to the global fight against AMR, securing equitable access to prevention, treatment and care for all, especially vulnerable populations.
For further details, see: https://www.who.int/groups/civil-society-task-force-on-antimicrobial-resistance
The US Food and Drug Administration (FDA) has issued a draft guidance titled ‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies’.
This guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application under the Public Health Service Act (PHS Act).
To access, see: https://www.fda.gov/media/189366/download
The global quality standard, ISO 9001, is set to have a new edition in 2026. This is divided into:
Both have the status of ‘Draft International Standard’ (DIS). Copies are available via ISO.
Bacteriophages are viruses that infect (through injection of the viral genome into the bacterial cell cytoplasm) and can kill bacteria. Interest in the use of phage therapy began in the 1930s, although it was abandoned due to the development of antibiotics. However, as antimicrobial resistance continues to rise, there has been a renewed interest in bacteriophages to target pathogenic bacteria.
The European Medicines Agency (EMA) has issued guidance about the use of bacteriophages. The aim of this guideline is to clarify the regulatory expectations for quality documentation of bacteriophage active substances and finished products for human use within marketing authorisation applications.
The guidance addresses specific aspects regarding the manufacture, control of materials, characterisation, specifications, analytical control, reference standards and stability of bacteriophage active substances. In addition, guidance is given on the pharmaceutical development, manufacture, control and stability of the finished product.
Details about the guidance and its significance can be found here: https://www.clinicalleader.com/doc/phages-as-a-pharmaceutical-new-ema-guidance-on-antimicrobial-drug-development-0001
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently approved gepotidacin (Blujepa), the UK’s first new type of antibiotic for urinary tract infections (UTIs) in nearly 30 years.
For the millions of women with recurring UTIs, this is life changing news. UTIs affect half of all women at some point in their lives and lead to millions of NHS appointments and prescriptions each year. For the estimated 1.6 million women in the UK with chronic UTIs, repeated infections mean days off work, cancelled plans and constantly worrying about the next one.
Find out more here: https://www.bmj.com/content/391/bmj.r2142
Good Pharmacovigilance Practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.
The EMA has updated its guidance on GVP by including a final GVP annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines for pharmacovigilance.
From August 2027, the European Union regulation will cover intestinal / faecal microbiota and all activities that have a direct impact on quality, safety or effectiveness of such microbiota, from donor registration to human application and clinical outcome registration.
The regulation will apply to activities from donor registration, donor history review, examination and testing, collection, release and distribution to a medicinal product manufacturer. Consequent steps will be regulated under the EU framework for medicinal products.
A new international study led by the MHRA has exposed significant variability in microbiome research methods across the world, highlighting an urgent need to adopt unified standards for the global harmonisation of gut microbiome research.
The study involved leading laboratories across multiple countries testing identical samples of gut microbiome bacteria. Results revealed startling inconsistencies, with accuracy measures varying dramatically between laboratories, despite analysing the same samples.
Various issues can occur throughout the lifecycle of a medicinal product for human use. These can include new information in relation to the quality, safety and/or efficacy of the product. In some cases, this may lead to a major event as referred to in Regulation (EU) 2022/123.
The issue may have a serious impact on public health and/or could have important policy or reputational consequences for the European Medicines Regulatory Network (EMRN). A new EMA guidance document describes the principles, framework and management of such issues (referred to as ‘incidents’).
Robotic dispensing systems and barcode scanning are used to identify medicines accurately, automate storage and retrieval, verify expiry dates and batch numbers, ensure the right product reaches the right patient (including automated dispensing or specific checks of the products due to administered on hospital wards). This process is only as safe as the data it relies on.
The MHRA has issued guidance on Global Trade Item Number (GTIN) and the 2D GSI DataMatrix barcode, which encodes the GTIN, batch number and expiry date, which aids the automation process.
Many individuals who are pregnant or breastfeeding require medicine(s) to treat or prevent acute or chronic medical conditions. Robust evidence is needed to develop meaningful product labelling. This supports well-informed decision-making by pregnant and breastfeeding individuals and their healthcare professionals on such medicine use.
A new International Council for Harmonisation (ICH) guideline has been introduced to provide recommendations for the appropriate inclusion of pregnant and breastfeeding individuals in clinical trials. It will facilitate the generation of clinical data that allow for evidence-based decision-making on the safe and effective use of medicinal products during pregnancy and breastfeeding.
The document, ‘ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials’, can be found here: https://www.ema.europa.eu/en/documents/other/ich-e21-guideline-inclusion-pregnant-breastfeeding-individuals-clinical-trials_en.pdf
Firms that process animal by-products (ABPs), such as animal carcasses or kitchen waste, may need to test samples of the products to check they are safe to use. This includes:
• ABP processing facilities (often known as a rendering plant)
• Composting or anaerobic digestate facilities
• Petfood factories
• Fertiliser factories (if ABPs used)
• Biodiesel plants (if ABPs used)
• Blood processors
• Milk processors
The UK Animal and Plant Health Agency (APHA) has issued updated guidance: https://www.gov.uk/guidance/laboratory-testing-requirements-for-animal-by-products-abps
As the use of viral vectors in Advanced Therapy Medicinal Products (ATMPs) continues to grow, ensuring these vectors are not replication-competent remains a critical safety step. However, existing recommendations often lack clarity or relevance for the diverse range of vectors in use today.
To address this, the British Pharmacopoeia (BP) has developed targeted guidance that offers practical, non-mandatory advice for testing replication competency in commonly used viral vectors such as Adeno-Associated Virus (AAV) and Lentivirus (LV).
This new guidance was developed in partnership with a working party of experts from the MHRA, NHS, industry and academia. It provides a harmonised framework aligned with existing standards, while allowing organisations the flexibility to tailor assays to their specific needs.
Read more here: https://www.pharmacopoeia.com/guidance/atmp
The EMA has updated its scientific advice for sponsors of clinical trials, referred to as ‘SA-CTA’. This document aims to clarify requirements for both clinical trial and marketing authorisation applications (or extension of indication applications) via increased collaboration. This includes the involvement of a newly created group of ethics experts (Public Health Emergency Ethics Advisory Group - PHE EAG).
The PHE EAG was set-up under the ACT EU initiative on clinical trials in public health emergencies with the help of MedEthicsEU.
The document can be accessed here: https://www.ema.europa.eu/en/documents/other/guidance-applicants-etf-scientific-advice-facilitates-clinical-trial-authorisations-sa-cta_en.pdf
The document ‘ICH E2D post-approval safety data management - scientific guideline’ has been updated (revision 1).
The revised Guideline ICH E2D(R1) provides updates on the definitions, standards and regulatory guidance for the management and reporting of post-approval drug safety information with the aim to support appropriate safety surveillance of medicinal products based on the current practices and needs.
New guidance also includes advice on the management of safety data from non-interventional studies with primary data collection, as well as from non-interventional studies with secondary use of data. Where applicable, the guideline notes where local and regional requirements may vary - marketing authorisation holders should refer to the relevant regional and local regulatory authority’s requirements.
The document can be accessed here: https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-topic-e-2-d-postapproval-safety-data-management-step-5_en.pdf
Since there is close contact between companion animals and humans, the use of antimicrobial Veterinary Medicinal Products (VMPs) in pets constitutes a potential risk for direct transfer of Antimicrobial-Resistant Bacteria (ARB), including relevant Antimicrobial Resistance Genes (ARG), between companion animals and humans.
As part of public health measures, the EMA has issued a draft guidance document titled ‘Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species’.
Since there is close contact between companion animals and humans, the use of antimicrobial Veterinary Medicinal Products (VMPs) in pets constitutes a potential risk for direct transfer of Antimicrobial-Resistant Bacteria (ARB), including relevant Antimicrobial Resistance Genes (ARG), between companion animals and humans.
As part of public health measures, the EMA has issued a draft guidance document titled ‘Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species’.
The European Union has updated its health threat plan to guard against a future pandemic. The revised document lays out an incident and crisis preparedness and management plan, i.e. a set of structures, processes and measures foreseen by EMA to prepare for and respond to incidents and crises in health threats to humans and related medicinal products.
Under the One Health approach, an integrated method with veterinary measures and medical countermeasures are considered where relevant.
The updated document can be found here: https://www.ema.europa.eu/en/documents/other/ema-health-threats-plan_en.pdf
The British Pharmacopoeia has updated its guidance on how to use and navigate the pharmacopoeia:
‘This update makes it easier for users to explore and understand the structure and content of a BP formulated preparation monograph. By introducing interactive, accessible elements, the guide supports a smoother, more intuitive learning experience while remaining true to the authoritative BP format.’
See: https://www.pharmacopoeia.com/guides/the-bp/how-to-use
A new ISO standard is in development for the food sector: ‘ISO/FDIS 24914 Microbiology of the food chain: Loop-mediated isothermal amplification (LAMP) for the detection of microorganisms and associated genetic markers - General requirements and definitions’.
This standard would provide general requirements and guidance for the development and application of LAMP-based methods for the detection of microorganisms and associated genetic markers sampled along the food chain (e.g., ingredients, human food, animal food and the production environment) and includes sample preparation, isothermal amplification, signal detection, data interpretation and performance criteria. This standard would also define laboratory and data management practices to ensure that LAMP methods are performed accurately and data is reported clearly for end users and stakeholders. Out of scope - LAMP methods applied for non-food (medical/veterinary) use.
The draft is accessible via national standards bodies.
Understanding the microbial content of soil has many applications, including the search for new antimicrobials.
A revised ISO standard has been issued titled ‘ISO 17601:2025 Soil quality - Estimation of abundance of selected microbial gene sequences by quantitative Polymerase Chain Reaction (qPCR) from DNA directly extracted from soil’.
This document specifies the crucial steps of a qPCR method to measure the abundance of selected microbial gene sequences from soil DNA extract. The number of microbial gene sequences quantified by qPCR provides an estimation of the abundance of selected microbial groups in soil.
The standard can be purchased from national standards bodies or direct from ISO.
ISO 8871-1:2003 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.
A new version of the standard is in development. This will update the series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclaves.
The draft is accessible via national standards bodies.
Two parts of the ISO 14644 cleanroom standards are under revision:
This standard presents guidelines for cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom. It provides guidance on the assessment of cleaning methods for achieving the required surface cleanliness by particle concentration (SCP) and surface cleanliness by chemical concentration (SCC) classes and which techniques should be considered to achieve these specified levels.
This standard specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644 1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644 1).
Sign up now and receive our regulatory update via email every month hassle free.
