The US Food and Drug Administration (FDA) updated its guidance document ‘Pyrogen and Endotoxins Testing: Questions and Answers (Edition 2)’ in March 2026.
The guidance provides recommendations for biological product, drug and device firms on the FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter ‘Bacterial Endotoxins Test’, USP Chapter ‘Medical Devices - Bacterial Endotoxin and Pyrogen Tests’ and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins - Test Methodologies, Routine Monitoring and Alternatives to Batch Testing (AAMI ST72).
The guidance can be accessed here: https://www.fda.gov/media/83477/download
Leachables are chemical entities that migrate from manufacturing components/systems, packaging or delivery device components into a drug product under the established manufacturing and labelled storage conditions. Extractables are chemical entities that are intentionally extracted from manufacturing components/systems, packaging or delivery device components under specified laboratory test conditions and thus are potential leachables.
The evaluation of these impurities requires a risk-based, holistic framework.
To help to accomplish this, The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline for extractables and leachables, looking at organic impurities, has been issued in draft. The document is ‘ICH Q3E Guideline for extractables and leachables Step 2b’ - the period for comment has now closed.
The document is also available via the European Medicines Agency (EMA/CHMP/ICH/236669/2025) at: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-q3e-guideline-extractables-leachables_en.pdf
The European Pharmacopeia (Ph. Eur.) has published its programme of works for 2026. To see which chapters and monographs are set to be updated, visit:
Radiopharmaceuticals are a special class of medicines, administered orally, by injection or inhalation for diagnostic or for therapeutic purposes. These medicines are usually given only once (or sometimes on a few occasions) and they contain only small amounts of a radiolabelled active substance that contains a radionuclide to allow imaging, measurement of biodistribution or therapeutic treatment.
Radiopharmaceuticals do often not show any measurable pharmacodynamic effect. Radiation is a general property of all radiopharmaceuticals, which when administered gives the patient an inevitable radiation dose. In the case of therapeutic radiopharmaceuticals, the radiation effect is the wanted property.
The ICH has issued new draft guidance entitled ‘Guideline on quality of radiopharmaceuticals’ - public consultation ends on 30 April 2026.
The document can be accessed here: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-radiopharmaceuticals-revision-2_en.pdf
The European Medicines Agency (EMA) has finalised a new guidance titled ‘Guideline on the Development and Manufacture of Synthetic Peptides’. This document, reference EMA/CHMP/CVMP/QWP/367182/2025, comes into effect on 1 June 2026.
Synthetic peptides are at the interface of small molecules and proteins. From a quality point of view, specific considerations apply to this class of therapeutics. These peptides are artificially produced short chains of amino acids, often designed to mimic natural molecules for use in drug delivery, medical diagnostics and therapeutic applications. These molecules are widely used to create targeted cancer treatments, vaccines as well as weight loss aids (e.g., GLP-1 agonists), offering advantages like high specificity and stability.
The unique properties of the microgravity environment enable more precise drug formulation, particularly for biologics and protein-based drugs such as monoclonal antibodies, vaccines or insulin. Microgravity conditions can improve drug solubility, purity, crystallisation and stability, supporting more effective delivery and potentially lowering manufacturing risk and cost. Hence, in-orbit manufacturing of pharmaceuticals offers transformative potential across multiple domains.
The UK Space Agency, the Medicines and Healthcare products Regulatory Agency (MHRA), the Regulatory Innovation Office (RIO) within the Department for Science, Innovation and Technology (DSIT) and the Civil Aviation Authority (CAA) are working collaboratively to provide a supportive regulatory environment to space, biopharma and pharmaceutical companies through collaborative work on guidance, regulatory sandboxes, case studies and supply chain engagement.
For further details, see: https://www.gov.uk/government/news/joint-statement-from-the-uk-space-agency-the-medicines-and-healthcare-products-regulatory-agency-the-regulatory-innovation-office-and-the-civil-avia
According to the ISO TC209 Cleanrooms & Associated Controlled Environments committee, a standard for Biofluorescent Particle Counters (BFPCs) is in development.
These are instruments that detect and count airborne biological particles (like bacteria and fungi) in real-time using Laser-Induced Fluorescence (LIF), offering a faster, automated alternative to traditional culture-based methods in pharmaceutical cleanrooms for environmental monitoring. Standards are already being developed to address calibration, but there is a need for information and guidance on the applications, particularly in the life-science sector.
The following standards will be proposed for citation in the Official Journal of the European Union (OJEU):
The following ongoing standardisation activities will be further developed in 2026:
A ban on the sale and supply of plastic-containing wet wipes to consumers is set to come into force in spring 2027, following an 18-month transition period according to Cleanroom Technology.
The Environmental Protection (Wet Wipes Containing Plastic) (England) Regulations 2025
UK Statutory Instruments2025 No. 1218 - https://www.legislation.gov.uk/uksi/2025/1218/part/1/made
However, wipes used in cleanrooms, laboratories and medical environments will be exempt under professional-use provisions.
Professional-use wipes, including those designed for cleanrooms and specialist industrial settings, are excluded where they are deemed vital for infection control, patient safety and operational safety
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To read the full article, see: https://www.cleanroomtechnology.com/uk-wet-wipe-ban-starting-2027-cleanroom-and
On 11 March 2026, the FDA launched the Adverse Event Monitoring System. This takes the form of a single, unified platform, replacing several separate reporting databases. By the end of May 2026, every adverse event report across every FDA-regulated product category will go through this one system. The new system has real-time publication (whereas the previous system only updated quarterly).
Already live in the system are:
Migrating to AEMS by the end of May 2026:
The agency also plans to migrate historical data from the legacy systems into the new system and roll out new data analytics tools.
Where procedures reference specific legacy systems, updates will need to be made.
For further details, see: https://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool?utm_source=substack&utm_medium=email
The Australian Therapeutic Goods Administration (TGA) announced (January 22) the release of the TGA Compliance Principles 2026 - 2027, unveiling a realignment around core principles to monitor.
This is around five guiding principles:
To access see: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement/compliance-principles-2026-and-2027
The International Standards Organization (ISO) is updating the following standards of interest:
The FDFA has issued a draft guidance with the aim to provide drug developers with a validation framework and general recommendations for using New Approach Methodologies (NAMs) in drug development.
Although animal toxicity studies have proved to be a critical method to identify potential risks to human health, finding ways to improve human relevance while reducing the use of animals by developing reliable NAMs furthers an important priority to move away from reliance on animal testing.
The recommendations in this draft guidance are intended to highlight scientific principles of study design and reporting that can be applied broadly and flexibly in the validation of NAMs used in drug development. This draft guidance is not intended to address specific NAMs and does not address the use of NAMs in drug discovery - rather, it encourages the use of NAMs in regulatory submissions, especially when they improve the predictivity of nonclinical studies for increased safety in clinical trials.
The draft guidance is titled ‘General Considerations for the Use of New Approach Methodologies in Drug Development’ and it can be accessed here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-use-new-approach-methodologies-drug-development
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