The document includes details on suitable procedures and equipment to carry out appropriate microbiological analyses on a sample and provide a meaningful interpretation of test results.

 

See: https://assets.publishing.service.gov.uk/media/67e673f78ac59d1882eadda1/Hospital_FWE_Microbiology_Guidelines.pdf

 

 

 

Public health (notifiable microorganisms)

 

The UK Department of Health has updated its list of microorganisms that pose a risk to public health. The list can be found here: https://www.gov.uk/guidance/notifiable-organisms-and-how-to-report-them 

 

 

 

Good Laboratory Practice (GLP) for safety tests on chemicals

 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated information from the UK GLP monitoring authority. See: https://www.gov.uk/guidance/good-laboratory-practice-glp-for-safety-tests-on-chemicals#full-publication-update-history

 

 

 

Biosimilars

 

The MHRA has updated their ‘Guidance on the licensing of biosimilar products’. A biosimilar is a biological medicinal product that contains a version of the active substance of an authorised original biological medicinal product - the Reference Medicinal Product (RMP). The purpose of this guideline is to provide developers of similar biological medicinal products (also known as biosimilars) with a clear outline of the requirements for biosimilar products in the UK.

 

See: https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products

 

 

  

Stability guidelines

 

The International Council for Harmonisation (ICH) released an overhauled stability guideline for consultation on April 17. This update consolidates five existing stability guidelines into a single, comprehensive document.

 

The new guideline completely rewrites the previous Q1A(R2) guidance from 2003. According to the accompanying presentation, the guideline ‘should be considered in its entirety for a comprehensive approach to stability studies.’

 

This revision was prompted by the ICH Quality Discussion Group (QDG), which identified stability and specification topics as ‘highest priorities’.

 

Structure and organisation

The guidelines span 108 pages and are organised into 18 sections plus three annexes. Key sections include:

 

• Section 1: Introduction outlining the purpose and explaining how the structure differs from existing stability guidelines
• Section 2: Development of stability studies under stressed and forced conditions, consolidating content from ICH Q1A and Q5C
• Sections 3-7: Protocol design for formal stability studies, covering batch selection, container closure systems, testing frequency and storage conditions
• Sections 8-11: Complementary stability studies including photostability testing, processing/holding conditions for intermediates, short-term storage and in-use stability

 

The guideline also introduces several new topics not covered in previous versions:

 

• Section 12 is a new addition addressing stability considerations for reference materials, novel excipients and adjuvants. The guidance notes that ‘novel excipients and adjuvants are discussed due to their significant potential impact on the quality of the drug product.’
• Annex 3 provides stability guidance specifically for Advanced Therapy Medicinal Products (ATMPs), which are new to ICH
• Annex 1 addresses bracketing and matrixing (currently captured in ICH Q1D), while Annex 2 provides guidance on stability modelling, including content currently in ICH Q1E
• Section 13 covers data evaluation and introduces a new section on statistical evaluations, while Section 14 pertains to labelling and storage statements. Section 15 discusses stability lifecycle management

 

See: https://database.ich.org/sites/default/files/ICH_Q1EWG_Step2_Draft_Guideline_2025_0411.pdf  

 

 

 

Medical Device Regulation

 

The British Standards Institute (BSI) has published a paper describing the interplay between medical device manufacturers and the EU Medical Devices Regulation.

 

The paper includes a summary of the regulations, classification of AI systems, conformity assessment process, roles of economic operators and additional requirements coming from the Artificial Intelligence Act (AIA) for high-risk AI enabled medical devices.

 

For details, see: https://pages.bsigroup.com/l/35972/2025-03-27/3t8qpf4

 

 

 

Controlled drugs

 

Many pharmaceutical and healthcare organisations are permitted to keep controlled drugs. In the UK, this is administered through a Home Office licence. This list has recently been updated and can be found here: https://www.gov.uk/government/publications/controlled-drugs-list--2/list-of-most-commonly-encountered-drugs-currently-controlled-under-the-misuse-of-drugs-legislation

 

 

 

Sterilisation

 

The International Standards Organisation (ISO) has issued a technical report relating to Washer-disinfectors (WD): ‘TC 198 Sterilization of health care products ISO 15883-7:2025 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment.’

 

This document also specifies the performance requirements for the cleaning and disinfection of the WD, its components and accessories.

 

In addition, this document specifies the methods for type testing, works testing, validation (installation, operation and performance qualification on first installation), routine control, and monitoring, as well as re-qualifications to be carried out periodically and after essential repairs.

 

The document is accessible via your applicable national standards organisation (e.g. BSI).

 

 

 

Biotechnology

 

ISO have issued a draft technical report – ‘ISO/DTR 4752 Biotechnology — Inventory of methods for detection of microbiological contamination in mammalian cell culture.’

 

This will form part of the process for the standardisation of analytical methods to enable accurate, reproducible and robust measurements and analysis of biologically relevant molecules and entities.

 

The document is accessible via your applicable national standards organisation (e.g. BSI).

 

 

 

Food

 

Salmonella detection

The following food related standard has been issued in 2025 (an ISO standard also adopted within the European Union):

EN ISO 6579-4:2025 ‘Microbiology of the food chain - Horizontal method for the detection, enumeration and serotyping of Salmonella - Part 4: Identification of monophasic Salmonella Typhimurium (1,4,[5],12:i:-) by polymerase chain reaction (PCR) (ISO 6579-4:2025).’

This document specifies a horizontal in vitro method for the molecular identification and differentiation of the monophasic variant of Salmonella enterica subsp. enterica serovar Typhimurium. The method detects specific DNA sequences of an intergenic region of the first H phase flagellin cluster for identification.

Cryptosporidium and Giardia

ISO are advancing their array of food related standards. This includes an amendment to a 2016 issued standard: ‘ISO 18744:2016/ DAmd 1 Microbiology of the food chain - Detection and enumeration of Cryptosporidium and Giardia in fresh leafy green vegetables and berry fruits’.

The 2025 amendment is: ‘Amendment 1: Method validation studies and performance characteristics’.

ISO 18744:2016 specifies a method that is applicable for the detection and enumeration of Cryptosporidium oocysts and Giardia cysts on or in food products that are described herein as fresh leafy green vegetables and berry fruits. With suitable controls, it may also be applicable for the examination of other fresh produce.

The amendment provides additional content not included in the text of the existing standard. The document is accessible via your applicable national standards organisation (e.g. BSI).

 

Draft standards

Also in relation to food, the following standards are currently undergoing review:

• CEN/TC 463 prCEN ISO/TS 17728 rev (WI=00463111)
  o Microbiology of the food chain - Sampling techniques for microbiological analysis of food and feed samples
• CEN/TC 463 prEN ISO 11133 rev (WI=00463110)
  o Microbiology of food, animal feed and water - Preparation, production, storage and performance testing of culture media

 

 

 

Pharmacovigilance following agreement of the Windsor Framework

 

The MHRA has updated its January 2025 guidance designed to provide information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.

 

This should be used in conjunction with the MHRA guidance on the Windsor Framework including UK-wide licensing for human medicines, as well as labelling and packaging guidance. 

 

The update can be accessed here: https://www.gov.uk/government/publications/pharmacovigilance-following-agreement-of-the-windsor-framework/pharmacovigilance-following-agreement-of-the-windsor-framework

 

 

 

Controlled environments

 

Many controlled environments seek to reduce microbial contamination from shoes, not least because of the resuspension effect. There are also considerations for inside the shoe itself.

 

ISO are issuing a technical report relating to the antimicrobial properties of footwear: ‘TC 216 Footwear ISO/DIS 20681 Footwear and footwear components — Test method to assess antimicrobial activity - Agar diffusion test’.

 

This document specifies a test method for evaluating the antimicrobial (antibacterial and/or antifungal) activity of footwear and footwear components. This document is applicable to all types of footwear and footwear components employing diffusing antimicrobial treatments.

 

This report is due to be issued in June 2025. 

 

 

 

Disinfection (food safety)

 

In relation to viruses and food safety, the European Committee for Standardization (CEN) have issued the standard: CEN/TC 216 EN 17914:2025 (WI=00216125), entitled ‘Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the food, industrial, domestic and institutional area - Test method and requirements (Phase 2/Step 1)’.

 

This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when diluted with hard water or, in the case of ready-to-use products (i.e. products that are not diluted when applied), with water.

 

This document is applicable to:

• Food of animal origin
• Food of vegetable origin 
• Flour, milling and baking products
• Animal feeds
• Institutional and domestic areas
• Packaging materials
• Biotechnology and pharmaceutical
• Cosmetics and toiletries

 

The document is accessible via CEN or through a national standards body.

 

 

 

Disinfection (forthcoming)

 

The following European Norms (CEN standards) are currently being drafted, relating to disinfection:

 

CEN/TC 216    (WI=00216151)
Chemical disinfectants and antiseptics — Quantitative test method for the evaluation of virucidal activity on nonporous surfaces with mechanical action employing wipes in the medical area (4- field test) — Test method and requirements (phase 2, step 2) 

 

CEN/TC 164    (WI=00164784)
Water conditioning equipment inside buildings — Devices using UV LED units — Requirements for performance, safety and testing.