The Medicines and Healthcare products Regulatory Agency (MHRA), acting jointly with the Department of Health in Northern Ireland (DoH [NI]), has launched a consultation calling to update the legal definition of Gene Therapy Medicinal Products (GTMPs) in the UK. The proposed changes aim to ensure UK regulation keeps up with advances in gene therapy, synthetic biology and gene editing technologies.

 

Gene therapies have evolved significantly since the current definitions were established more than a decade ago. Since then, advances in science and manufacturing technologies have prompted consideration on whether the wording remains appropriate for use. 

 

The MHRA is consulting on updated definitions that would classify a medicinal product as a gene therapy based on how it works.  

 

For further details, see: https://www.gov.uk/government/news/mhra-opens-uk-wide-consultation-on-redefining-gene-therapies 

 

 

Chromatography

 

The British Pharmacopeia (BP) has an article about chromatography and some of the System Suitability Test (SST) requirements, which can be found in the chapter on ‘Chromatographic Separation Techniques’ (CST).

 

This supporting article covers:

• System suitability requirements of CST
• Peak symmetry
• System sensitivity 

 

The article can be found here: https://www.pharmacopoeia.com/news/key-insights-focus-on-chromatography?preview=true 

 

 

 

BP consults on upcoming draft texts

 

The BP is seeking public consultation and feedback period for some draft revised texts. These are:

• Rizatriptan Orodispersible Tablets
• Nitrazepam Tablets
• Nitrazepam Oral Suspension
• Lidocaine Injection

 

Consultation is open until 30 June 2026. The link is: https://www.pharmacopoeia.com/news/q2-26-draft-texts 

 

 

 

Proposed changes to medical device regulation

 

New pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market have been published by the MHRA on the World Trade Organisation (WTO) notification portal.

 

The notification provides an opportunity for WTO members to comment on the draft pre-market regulatory requirements, titled ‘Medical Devices (Amendment) Regulations 2026’.

 

For details, see: https://www.gov.uk/government/news/mhra-invites-views-on-proposed-changes-to-medical-device-regulation

 

 

 

Maximum residue limits

 

The Maximum Residue Limit (MRL) is the highest concentration allowed for a residue in a food product obtained from an animal that has received a veterinary medicine or that has been exposed to a product used to kill or control germs or pests affecting animals.

 

The European Medicines Agency (EMA) has updated its questions and answers document: https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/maximum-residue-limits-mrl/maximum-residue-limits-mrls-questions-answers 

 

 

 

Clinical trials: ICH

 

The ICH M11 Expert Working Group has issued a final overview presentation (at Step 4 of the ICH harmonisation process) for ICH M11: The Clinical electronic Structured Harmonised Protocol (CeSHarP), a guideline adopted in November 2025.

 

ICH M11 is a comprehensive guideline that consists of three interconnected documents that together standardise clinical trial protocol format, content and exchange: a harmonised guideline, a clinical trial protocol template and a technical specification to enable the electronic exchange of protocol contents.

 

These three documents apply to interventional clinical trials of medicinal products across all phases and therapeutic areas, covering pharmaceuticals, biologics, vaccines, drug-device combinations and cell or gene therapy products.

 

To review, see: https://www.ich.org/news/ich-m11-expert-working-group-issues-final-overview-presentation 

 

 

 

Growing in aseptic services video

 

NHS Aseptic Services has issued a useful video on gowning best practices for entering cleanrooms. 

 

Effective gowning in pharmacy aseptic services protects the cleanroom environment and therefore protects medicines from potential contamination during preparation.

 

This 23-minute video explores principles to consider when developing a gowning strategy and provides examples of where practices can fall short. The video will be of interest to those working in mainstream pharma as well as healthcare.

 

The video can be found here: https://www.sps.nhs.uk/articles/gowning-in-aseptic-services/ 

 

 

 

The importance of titre analytics in bioprocessing

 

Titre analytics is often treated as a black box in bioprocessing, says Ruizhi Wang, founder and CEO of Abselion. Wang notes that as regulatory expectations increase, integrating analytics into bioprocessing can significantly improve efficiency and transparency.

 

An article relating to this topic is available from The Medicine Maker: https://themedicinemaker.com/issues/2026/articles/may/breaking-the-black-box-in-bioprocessing/ 

 

 

 

FDA official details top observation from QMSR

 

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing, purchasing, complaint handling and feedback.

 

This relates to an article from the Regulatory Affairs Professional Society, see: https://www.raps.org/resource/fda-official-details-top-observations-from-qmsr-inspections.html

 

 

 

Critical medicines act

 

The European Parliament and the Council of the European Union have reached ‘provisional agreement’ on the proposed Critical Medicines Act (CMA). This legislation represents an important step in strengthening the resilience, security and sustainability of the European Union’s supply of critical medicines.

 

In recent years, EU Member States have faced serious medicine shortages and global challenges such as the COVID-19 pandemic and geopolitical tensions have exposed vulnerabilities in the pharmaceutical supply chain. Shortages of medicines can put patients' lives at risk and place a significant burden on healthcare systems. They may arise from reasons including manufacturing issues, supply chain vulnerabilities or global competition for resources.

 

By combining regulatory tools with targeted industrial policy measures, the CMA strengthens preparedness and supports a more resilient supply of medicines for patients. It builds on the regulatory tools introduced through EMA’s extended mandate and complements the measures in the revised EU pharmaceutical legislation, to reinforce manufacturing capacity and supply resilience for critical medicines. It also aims to improve access to other medicines of common interest which may not be available in certain EU markets, such as medicines for rare diseases.

 

For details see: https://ec.europa.eu/commission/presscorner/detail/en/ip_26_1017

 

 

 

EU GMP - Annex 22 update

 

The European Medicines Agency (EMA) continues to work on the proposed Annex 2, relating to Artificial Intelligence.

 

EMA's Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group is organising a two-day workshop to help shape a risk-based approach to the use of generative Artificial Intelligence (AI) in medicines manufacturing.

 

The event is titled ‘Good Manufacturing Practice: Multistakeholder Workshop on Expert Contributions to Artificial Intelligence Guidance Development (Annex 22)’.

 

Key topics are:

• How could we accommodate adaptive and probabilistic models in Annex 22?
• What would be the validation paradigm for adaptive models that should be in Annex 22?
• To what extent can available guardrail mechanisms reliably prevent, detect or contain hallucinations, incorrect recommendations or fabricated data when dynamic or adaptive models, probabilistic models and generative AI / LLMs are used within GMP workflows?
• When guardrails fail or detect uncertainty, what mechanisms are required to ensure timely escalation and prevention of GMP impact?
• What level and form of human-in-the-loop oversight is still required when guardrails are implemented?
• Is this oversight sufficient to ensure accuracy, traceability and accountability?
• How can guardrails remain effective when the underlying AI model evolves (in instances such as updates, retraining and drift)?
• What controls are necessary to ensure guardrail performance remains validated over time?
• What type and level of evidence (such as validation data, stress testing results and failure analyses) would be needed to justify that guardrails are a reliable risk mitigation measure enabling generative AI use in GMP functions?
• Can you demonstrate the effectiveness of such guardrails or similar measures?
• Do current guardrail approaches sufficiently address GMP high-risk areas such as data integrity, process control, auditability and traceability - especially where generative AI systems may influence or automate decision-making?
• Where do experts believe the limits of risk-based mitigation lie?
• Are there classes of critical decisions where no combination of guardrails and oversight would be sufficient?
• Are there scenarios in which the level of guardrail effort required to mitigate generative AI risks becomes disproportionate or operationally impractical, thereby indicating that such systems should not be used in certain critical GMP functions?
• What other elements of an overall control strategy should be considered for inclusion in the Annex 22 to allow the use of dynamic or adaptive models, probabilistic models and generative AI / LLMs in GMP applications?
• Is there a need to address prevention and protection of AI systems from tampering or unauthorised access in Annex 22 or is this already sufficiently addressed in Annex 11?
• What risks arise when guardrail infrastructure is outside the manufacturer’s direct control?
• How can supplier qualification, change-control visibility and independent audit capabilities be preserved in cloud-based AI supply chains?

 

The workshop is running on from 30 June -1 July 2026. For details, see: https://www.ema.europa.eu/en/events/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22

 

 

 

Q&A on implementation of Ph. Eur. Medicinal Product Monographs (MPM)

 

The EMA issued a question-and-answer document during April 2026. This is an update of EMA/CHMP/QWP/505156/2023 - Rev.1.

 

The document answers a series of questions relating to the European Pharmacopeia. It can be found here: https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-pheur-medicinal-product-monographs-mpm_en.pdf 

 

 

 

Europe and data processing

 

The EMA has updated its guidance relating to the data it collects when receiving information via Microsoft products. The document is titled ‘Records of data processing activity for the use of Microsoft Applications: OneDrive, Outlook 365, Teams and SharePoint’.

 

The document can be found here: https://www.ema.europa.eu/en/documents/other/records-data-processing-activity-use-microsoft-applications-onedrive-outlook-365-teams-sharepoint_en.pdf 

 

 

 

Biosimilars and veterinary medicine

 

There is currently no guidance available for veterinary biosimilars concerning how comparability with a biological reference veterinary medicinal product can be demonstrated.

 

To address this, the EMA has issued a draft paper titled ‘Concept paper on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products’. 

 

Consultation finishes at the end of July 2026. The paper can be accessed here: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-development-guidance-demonstration-biosimilarity-biological-veterinary-medicinal-products_en.pdf 

 

 

 

Residual solvents

 

Annexes to ICH Q3C guideline on impurities: Guideline for residual solvents (EMA/CHMP/ICH/82260/2006) and VICH GL18 Impurities: Residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/1999) - Revision 2, have been updated.

 

The annexes relate to ICH Q3C (R9) Guideline on impurities guideline for residual solvents - Step 5, which was issued in 2024. 

 

This relates to recommended acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.

 

To access, see: https://www.ema.europa.eu/en/ich-q3c-r9-residual-solvents-scientific-guideline

 

 

 

Clostridioides difficile

 

The U.S. Food and Drug Administration (FDA) has issued a new guidance document titled ‘Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention’.

 

The purpose of this guidance is to assist sponsors in the clinical development of drugs to support an indication of treatment, reduction of recurrence, or prevention of Clostridioides Difficile Infection (CDI). 

 

The bacterium that produces two pathogenic enterotoxins, Toxin A (TcdA) and Toxin B (TcdB). Some C. difficile strains (e.g., 027/BI/NAP1) produce a third toxin called binary toxin, which has been associated with increased production of TcdA and TcdB and more severe CDI.

 

The guidance document can be found here: https://www.fda.gov/media/162692/download

 

 

 

Gene therapy

 

To aid the advancement of gene therapy-based medicines, FDA has issued a guidance titled ‘Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application’.

 

This guidance describes how FDA applies flexibility to the Chemistry, Manufacturing and Controls (CMC) requirements for human Cellular and Gene Therapy (CGT) products being developed for Biologics License Applications (BLAs) under Title 21 of the Code of Federal Regulations (CFR) Part 601 (21 CFR 601). 

 

The document discusses the FDA’s flexible approach serves to help expedite development, review and patient access to safe and effective CGT products to treat serious or life-threatening conditions that represent significant unmet medical needs.

 

The guidance can be found here: https://www.fda.gov/media/192321/download

 

In addition, FDA has issued a draft guidance called ‘Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing’. This guidance is intended for sponsors developing human gene therapy drug products involving genome editing technologies.

 

The draft guidance can be accessed: https://www.fda.gov/media/191966/download

 

 

 

Antibiotics

 

The FDA has issued a draft document titled ‘Establishing Impurity Specifications for Antibiotics’.

 

The guidance provides recommendations to industry for establishing specifications for impurities in antibiotics manufactured by fermentation and semi-synthesis. These recommendations can be used to establish consistent standards for impurity testing and ensure that batches of antibiotic drug products meet appropriate impurity specifications.

 

The draft is located here: https://www.fda.gov/media/192017/download