Review of Developments in GMP and the Regulation of Medicines November 2025 

EJPPS Volume 30.4B 

INTRODUCTION

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the UK, EU, Australia and PIC/S regulatory authorities.

The topics covered in this edition of the “Update” include:

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

·       Regulation in an age of personalised medicine

·       MHRA smashes major illicit weight loss medicine production facility

·       UK clinical trial approval times twice as fast with AI and reforms

·       MHRA and NICE invite early adopters to trial accelerated aligned pathway

·       The new Innovative Licensing and Access Pathway welcomes first investigational products

·       AI tools that could detect diseases earlier selected for next phase of MHRA’s ‘AI Airlock’ programme

·       BLOG- A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors

·       A new antibiotic is positive news – but it will take more to stay ahead of superbugs

·       Protecting patients through biological standards for medicines

·       MHRA Performance Data

·       Blog- Clinical trials regulations: six-month countdown begins

EU

European Medicines Agency (EMA)

·       EMA Management Board: highlights of October 2025 meeting.

·       Network data strategy

·       Annual report of the Pharmacovigilance Inspectors' Working Group for 2024

·       Guideline on in-use stability testing of veterinary medicinal products

·       Frequently asked questions about parallel distribution

·       EMA partners with content creators to promote safe and responsible use of GLP-1 medicines

·       Non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation - Scientific guideline

·       Guideline on quality aspects of phage therapy medicinal products

The European Directorate for the Quality of Medicines & HealthCare (EDQM)

·       New quantification method for suspected adulteration with ethylene glycol and diethylene glycol to be included in the Ph. Eur.

·       Pharmeuropa 37.4 just released

·       European Drug Shortages Formulary (EDSForm)

·       Reference standards

·       European Pharmacopoeia Issue 12.2

Ireland

The Health Products Regulatory Authority (HPRA)

·       Human Tissues Act – review existing procedures

·       HPRA health warning after detention of counterfeit tirzepatide pens containing insulin

·       Prepraring for SoHo – updates on implementation

·       EU Biotech Act public consultation opens for input

USA

The US Food and Drug Administration (USFDA)

No news items reported as a result of the ongoing Federal Government shutdown.

International

Australia

Therapeutic Goods Administration (TGA)

·       Illegal vapes and cigarettes worth close to $9 million seized in joint operation

The Pharmaceutical Inspection Co-operation Scheme (PIC/S)

·       Nigeria, Tanzania, Rwanda and Senegal become PIC/S Pre-Applicants

Products

·       MHRA- Concizumab approved to prevent or reduce the frequency of bleeding episodes in people aged 12+ with haemophilia

·       EMA confirms suspension of sickle cell disease medicine Oxbryta

RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

Regulation in an age of personalised medicine

Lawrence Tallon, Chief Executive of the MHRA summarises -. “In this guest article for the MHRA, Professor Sir David Spiegelhalter, the internationally renowned expert in the calculation and communication of risk and statistics, discusses the concept of a ‘preference zone’ to frame the demands of safety, efficacy and choice in the era of personalised medicine. He draws insights from his experiences of the Covid-19 pandemic and, more recently, his perspective as a patient for whom this calculation is personal as well as professional.”

[The age of personalised medicine is racing along and day to day involves more of us in our work activities and from time to time in our personal lives. This article is well worth a read and offers a view from both perspectives. MBH]

MHRA smashes major illicit weight loss medicine production facility

Officers from the Criminal Enforcement Unit (CEU) of the MHRA have dismantled a major illicit manufacturing facility, making and distributing unlicensed weight-loss jabs, during a raid on a warehouse in Northampton.  This is the first illicit production facility for weight loss medicine discovered in the UK and is believed to be the largest single seizure of trafficked weight loss medicines ever recorded by a law enforcement agency worldwide. 

The street value of the finished weight loss products alone is estimated to be more than a quarter of a million pounds. 

Along with large amounts of sophisticated packaging and manufacturing equipment, officers recovered approximately £20,000 in cash suspected to be linked to medicines trafficking. 

The site, on an industrial estate on the outskirts of Northampton, is believed to have been used for the large-scale manufacture, packaging, and distribution of unlicensed, (and potentially deadly),  weight loss products to customers.  

UK clinical trial approval times twice as fast with AI and reforms

Patients receive earlier access to life-saving treatments as UK trial approval times cut in half from 91 to just 41 days.

This means patients can safely access promising new treatments – from cancer therapies to rare disease studies – several weeks sooner than before.

Findings published this week (6 October) show the reforms are delivering consistently strong results, with 99 per cent of applications reviewed within statutory timelines, and most completed well ahead of target.

The study is the first comprehensive review of the MHRA’s new way of reviewing trials based on their level of risk, introduced in 2023, showing how it speeds up review timelines while protecting patient safety.

Building on this, artificial intelligence (AI) is now being introduced to further support assessors – helping review complex data and improve consistency – while final decisions continue to rest with experienced assessors to ensure patient safety.

MHRA and NICE invite early adopters to trial accelerated aligned pathway

Pharmaceutical companies who make qualifying medicines can now take advantage of a streamlined approvals pathway for medicines much earlier than anticipated.  MHRA and NICE are now offering some pharmaceutical companies early access to the aligned pathway six months earlier than projected, as user research begins to shape the next phase of the programme.

The pathway is now accepting applications from manufacturers who make medicines which have been designated by the NICE and the MHRA for early access. The pathway brings together the MHRA’s licensing process and NICE’s value assessment process, meaning decisions will be published at the same time, instead of consecutively. This will reduce the 90-day gap between marketing authorisation and NICE guidance decisions, meaning faster patient access, support for the NHS and a more efficient route for industry.

The new Innovative Licensing and Access Pathway welcomes first investigational products

Three potential therapies – including one that could be a lifeline for babies born with a fatal metabolic disorder and another for boys with the muscle-wasting condition Duchenne muscular dystrophy – have become the first to enter a new UK scheme designed to help promising new medicines reach NHS patients faster.

The Innovation Passport gives developers coordinated support from the earliest stages of development, with priority access to services such as clinical trials support and NHS engagement, to help speed up access for patients where current treatment options are limited or non-existent.

What makes ILAP unique is that it is the only end-to-end pathway in the world where healthcare developers, the regulator, the UK-wide national health system, and the health technology assessment (HTA) bodies work together from the outset. By giving developers early, coordinated guidance on safety, effectiveness and value requirements across the system, the scheme is designed to reduce the time it takes for promising new treatments to move through development, licensing and, if approved, to NHS patients.

AI tools that could detect diseases earlier selected for next phase of MHRA’s ‘AI Airlock’ programme

Artificial intelligence (AI) tools that could transform patient care – from reducing bowel cancer test times from weeks to minutes, to detecting skin cancer and genetic eye diseases sooner – are being tested in the next phase of the Medicines and Healthcare products Regulatory Agency’s (MHRA) AI Airlock programme. Seven manufacturers developing novel AI-powered healthcare technologies have been selected for the second phase of the programme, which provides a controlled environment to trial AI tools safely, ensure their effectiveness, identify limitations and challenges around the use of AI as a medical device, and explore potential pathways towards regulatory approval.

The chosen technologies span AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection, hospital stay summaries, and blood test interpretation – targeting critical challenges across the healthcare system and supporting clinicians to make faster, more informed decisions for patients. 

BLOG- A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors

The aviation and marine sectors are a journey away from the traditional scope of a Wholesale Dealer’s Licence (WDA(H)), and one of unique and specific challenges. The lorries and trucks that supply medicines to hospitals and pharmacies also head to aircrafts, ships, and oil platforms. The supply of medicines to these locations are vital to ensure that planes can fly, ships can sail and to ensure the safety and wellbeing of crew and passengers, as well as the people that work in these remote locations. The MHRA is committed to supporting stakeholders and to continue to provide guidance.

A new antibiotic is positive news – but it will take more to stay ahead of superbugs

The MHRA’s Interim Executive Director of Science and Research, Dr Nicola Rose, writes in The British Medical Journal on the approval of the UK’s first new UTI antibiotic in nearly 30 years, and the wider challenge of tackling antibiotic resistance.

[see September 2025 Update for details of this new antibiotic approval]

Protecting patients through biological standards for medicines

The MHRA produces over 95 per cent of the World Health Organization’s (WHO) biological standards.

The biological standards developed, produced, curated and supplied by the MHRA not only support the safe development, testing and use of a wide range of medicines, vaccines and diagnostic tests, but also make it possible for scientific discoveries to be compared, repeated and built upon. This involves experts from across the Science & Research Group at the MHRA, working closely with laboratories around the world.

The MHRA continues to lead in developing biological standards for new therapies – from monoclonal antibodies to cell and gene therapies. The MHRA now provides more than 450 different WHO standards that are widely used to help develop, test and monitor biological medicines and to make sure laboratory tests give accurate, comparable results. 

Standards are also becoming vital for fast-moving areas of science such as microbiome research – the study of the trillions of bacteria and other microorganisms that live in and on the human body.

MHRA Performance Data

This document was updated 23 October 2025

Blog- Clinical trials regulations: six-month countdown begins

O 28 April 2026, the most significant update to UK clinical trials regulations in two decades will come into force.

This will be a pivotal moment for the evolving clinical trial landscape and marks a new way forward for how trials involving medicinal products are set up and delivered across the UK.

Together, MHRA and the Health Research Authority (HRA) have developed amended regulations that have been shaped by - and will benefit - patients, researchers, health professionals, and industry.

By streamlining approvals processes, reducing duplication and supporting a proportionate and flexible approach to regulation, it will be quicker and easier to set up and run clinical trials, while maintaining the highest standards of safety. This will speed up vital research that could lead to new and better treatments for patients. Greater transparency of clinical trial results will help boost participation, inclusion and diversity.

Europe

European Medicines Agency (EMA)

EMA Management Board: highlights of October 2025 meeting

EMA presented results and achievements of its operations for the first half of 2025. Between January and June, applications for new medicines (orphan and non-orphan) remain at the same high level as last year (29 vs 30 applications in Q1-Q2 2024). In veterinary medicines, the Board noted the same high level of applications as in 2024 (12 vs 11 applications in Q1-Q2 2024). The Board welcomed the positive trend in reduction of company clock stop extensions in Q1-Q2 2025 - an average of 150 days compared to an average of 182 days in 2024 (an approximately 18% reduction). The 2025 mid-year report will be published on EMA’s website shortly.

Network Data Strategy

This strategy sets out the agreed European medicines regulatory network (EMRN) vision, principles to be followed and goals to be met to maximize the value of the data managed by the EMRN.

Success in implementing this strategy relies on effective collaboration with a diverse ecosystem of stakeholders who both contribute to and benefit from EMRN data, including healthcare professionals, patients and their organisations, the pharmaceutical industry, academia, health technology assessment bodies, and policymakers. Through this collaborative approach, the strategy aims to enhance the network's ability to protect public health while fostering innovation in medicines development and regulation.

Data are received, collected, created, updated, and enriched every day by organisations in the EMRN to serve as the basis for their decision making and as a necessary step in fulfilling their legally mandated tasks and other obligations.

Annual report of the Pharmacovigilance Inspectors' Working Group for 2024

This document is the fifteenth annual report of the Pharmacovigilance Inspectors Working Group (PhVIWG).

The PhV IWG focuses on the harmonisation and coordination of pharmacovigilance related activities at EU (hereinafter the "Union") level. The group supports the coordination of the provision of pharmacovigilance inspection related advice and provides a link to other groups such as the Committee for Medicinal Products for Human Use (CHMP), the Committee for Veterinary Medicinal Products (CVMP), the Pharmacovigilance Risk Assessment Committee (Human Medicinal Products) (PRAC [H]), and the Pharmacovigilance Working Party (Veterinary Medicinal Products) (PhV WP [V]).

Guideline on in-use stability testing of veterinary medicinal products

This guideline replaces and merges the ‘Note for guidance on in-use stability testing of veterinary medicinal products and the ‘Note for guidance on maximum shelf-life for sterile medicinal products after first opening or following reconstitution.

The purpose of in-use stability testing is to establish, where applicable, a period of time during which a multidose product may be used whilst retaining quality within an acceptable specification once the container is opened or broached. Based on this testing, a shelf-life after first opening/broaching is generally established and mentioned in the product information.

The continued integrity of products in multidose containers after the first opening/broaching is an important quality issue. This document attempts to define a framework for selection of batches, test design, test storage conditions, test parameters, test procedures etc., taking into consideration the broad range of products concerned.

The dossier for a multidose product should include the in-use stability data on which the in-use shelf- life is based. Alternatively, a justification as to why no in-use shelf-life is established should be included. In the case of solid oral dosage forms such as tablets, usually a justification for the absence of an in-use shelf-life will suffice. In the case of other non-sterile dosage forms, a justification based on experimental results may be necessary

The guidance came into effect 30 Sept 2025

Frequently asked questions about parallel distribution

The following sections of the document were revised in Oct 2025:-

3.14. What are the requirements for QR codes on the packaging material?

3.20. Who receives Notices for parallel distribution (PD)?

EMA partners with content creators to promote safe and responsible use of GLP-1 medicines

EMA has launched its first social media campaign working with content creators. The #HealthNotHype campaign aims to raise awareness about the safe and responsible use of GLP-1 receptor agonists.

These medicines were initially developed to treat type-2 diabetes, but some GLP-1 receptor agonists are now indicated for weight management in people living with obesity and weight-related health conditions.

From news coverage to social media and celebrity endorsements, awareness of GLP-1 receptor agonists and their use for weight loss is soaring, fuelling both interest and the risk of misinformation, misuse and other issues like illegal sales of counterfeit products.

“#HealthNotHype is about passing the message that GLP-1 receptor agonists are not magic solutions for weight loss. Like all medicines, they have benefits and risks and are not for everyone. They are long-term treatments that must be accompanied by other lifestyle changes, always under the supervision of a doctor. By working with content creators, we want to ensure that validated scientific information is part of the conversations people are having on social media about these medicines.”- States EMA’s Executive Director, Emer Cooke

Non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation - Scientific guideline

This reflection paper aims to provide an overview of the scientific and regulatory considerations for non human primate use in safety testing of human medicinal products. It highlights the existing flexibility within published guidelines to incorporate 3Rs approaches and describes novel alternative approaches which may become available in the future.  Notwithstanding the detailed conditions outlined herein, some important examples include; use of rodent species (including transgenics) only to evaluate repeat dose toxicity, the waiving of long-term (6 month) studies to evaluate the safety risk associated with monoclonal antibodies, the use of alternative assays to predict malformations or embryo-foetal lethality in developmental and reproductive toxicity. 

Comments should be provided by 31 Jan 2026,

Guideline on quality aspects of phage therapy medicinal products

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. It 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.

Deadline for comments 30 April 2026.

The European Directorate for the Quality of Medicines & HealthCare (EDQM)

New quantification method for suspected adulteration with ethylene glycol and diethylene glycol to be included in the Ph. Eur.

In light of continuing reports of paediatric syrups contaminated with ethylene glycol (EG) and diethylene glycol (DEG) linked with deaths in Africa and Asia, the European Pharmacopoeia Commission (178th session, March 2024) mandated the Carbohydrates Working Party (CRB WP) to establish a method capable of detecting and quantifying both these contaminants in sorbitol and maltitol, excipients that are widely used in syrup formulation,.A “Potential adulteration” section describing an analytical procedure for the quantification of EG and DEG when suspected to be present in harmful amounts has been included in the four European Pharmacopoeia (Ph. Eur.) monographs concerned, Sorbitol, liquid, partially dehydrated (2048), Sorbitol, liquid (non-crystallising) (0437), Sorbitol, liquid (crystallising) (0436) and Maltitol, liquid (1236), all of which have been published in Pharmeuropa 37.4 for comment. This is the first time that a group of experts has proposed to incorporate a “Potential adulteration” section as described in the Ph. Eur. The new section published in the four monographs describes a gas chromatography method to be used for the detection of harmful levels of EG and DEG when adulteration is suspected, with limits of 620 ppm for EG and 0.10 per cent for DEG. All users are encouraged to comment on these four texts in Pharmeuropa 37.4 (with a deadline for comments of 31 December 2025), viewing them as a package and considering whether a comment made on one of them also applies to the others.

Pharmeuropa 37.4 just released

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation.

Draft monographs must not be regarded as official standards, they will, once adopted by the Ph. Eur. Commission at a later date, become applicable and legally binding standards for the products concerned in all Ph. Eur. member states;

While general texts are not legally binding per se, they become mandatory when referred to in a monograph. Changes to general texts may therefore impact monographs.

It is therefore extremely important that users provide feedback on such drafts.

Similarly Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 37.4.

The deadline for comments on Pharmeuropa 37.4 is 31 December 2025.

European Drug Shortages Formulary (EDSForm)

EDQM announce the public consultation on the first three texts of its second formulary after the European Paediatric Formulary 

Healthcare professionals and interested parties across Europe are invited to provide feedback on the draft Amoxicillin capsules monograph and on the Introduction to the European Drug Shortages Formulary and the General principles of the European Drug Shortages Formulary, two general texts intended to help users navigate the content and concepts laid down in the Formulary.

The EDSForm brings together, at European level, monographs describing methods for the preparation and quality control of unlicensed pharmaceutical preparations that may be needed when licensed alternatives are unavailable.

Monographs selected for inclusion in the EDSForm are subject to rigorous evaluation based on criteria adopted by the CD-P-PH, including the reproducibility of the preparation process, therapeutic relevance and compliance with European Pharmacopoeia requirements.

Reference standards

14 new European Pharmacopoeia reference standard and 17 replacement batches were released in September 2025

European Pharmacopoeia Issue 12.2

The European Pharmacopoeia (Ph. Eur.) Issue 12.2 is now available and will be applicable in 39 European countries as of 1 April 2026.

Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2026,

Ireland The Health Products Regulatory Authority (HPRA)

Human Tissues Act – review existing procedures

Part 1 and 2 of the Human Tissues Act came into law in June 2025. It sets out key rules for organ and tissue donation. 

Authorised tissue establishments and organ donation and transplant centres must now review their procedures for consent and for transplantation conditions. This is to ensure they meet the requirements of all relevant legislation, including the new Human Tissues Act. 

The HPRA will continue to monitor these procedures during inspections. 

HPRA health warning after detention of counterfeit tirzepatide pens containing insulin

An ongoing investigation by the HPRA and Revenue’s Customs Service has identified a small consignment of counterfeit tirzepatide injection pens that have been found to contain insulin and could pose a serious health risk for consumers. The HPRA is advising members of the public to only source prescription medicines from a registered pharmacy using a valid prescription to ensure they are accessing legitimate authorised medicinal products. The consignment detained, which included falsified pens, was sourced online and originated from outside Europe. Laboratory tests confirm that two of the pens contain insulin instead of tirzepatide, posing a serious risk to unsuspecting users due to the possible onset of severe hypoglycaemia upon administration.

Prepraring for SoHo – updates on implementation

New EU rules for substances of human origin (SoHO) will replace existing regulations for blood, tissues, and cells. These changes will start from 7 August 2027, with some parts delayed until 2028.

Organisations working with these substances must prepare for compliance with the new regulations. To support compliance, it is important to stay informed about developments as implementation progresses.

The HPRA will publish updates in the relevant areas of the site

EU Biotech Act public consultation opens for input

The EU is asking for your views on the new Biotech Act. This Act will aim to speed up the development of biotech products, like new medicines and advanced treatments, while keeping patients' safety a top priority.

The new Biotech Act will help bring more medical research and clinical trials to Europe, including Ireland. This means patients here could get access to new treatments and medicines faster, while keeping strict safety standards in place. The Act will include proposals to improve and simplify the regulatory landscape, including changes to the Clinical Trials Regulation.

United States of America

The US Food and Drug Administration (USFDA)

No news items reported as a result of the ongoing Federal Government shutdown.

International

Australia

Therapeutic Goods Administration (TGA)

Illegal vapes and cigarettes worth close to $9 million seized in joint operation

A coordinated crackdown on illegal vapes in southeast Queensland has led to a significant seizure of illegal vaping and tobacco products with a street value exceeding $8.8 million. During the operation, the Therapeutic Goods Administration (TGA) seized illicit vapes, vaping accessories and nicotine pouches with a street value of more than $3 million. Queensland Health seized more than $5.8 million of illegal cigarettes and loose tobacco.The operation, which enforced vaping laws under the Therapeutic Goods Act 1989 (the TG Act) and Queensland’s tobacco legislation, was carried out by the TGA and Queensland Health, with support from the Queensland Police Service (QPS).The actions of the TGA and the Queensland Government are underpinned by the National Vaping Enforcement Framework, which aims to deter the illegal supply of vaping products and disrupt criminal networks profiting from the illicit vape trade.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Nigeria, Tanzania, Rwanda and Senegal become PIC/S Pre-Applicants

On 15 August 2025, a Rapporteur was appointed by written procedure for the pre-accession applications of the above regulatory bodies.

In line with the revised PIC/S Guidelines for the Pre-Accession Procedure, the designation of the Rapporteur marks the start of the pre-accession process.

Products

[This section makes reference to some of the most notable new products approved during the past month and focuses on approvals of medicines for which there is a previously unmet need and / or where approvals have been made using shared information from other trusted regulators.MBH]

Concizumab approved to prevent or reduce the frequency of bleeding episodes in people

aged 12+ with haemophilia A or B with inhibitors

MHRA has approved the medicine concizumab (brand name: Alhemo). The active substance, concizumab, which acts independently of factor VIII and factor IX, works by blocking a natural protein that prevents blood from clotting (known as tissue factor pathway inhibitor).

Concizumab is injected subcutaneously (under the skin) daily.

Approval was through the International Recognition Procedure (IRP).

The new marketing authorisation was granted to Novo Nordisk. 

EMA confirms suspension of sickle cell disease medicine Oxbryta

EMA’s human medicines committee (CHMP) has recommended that the marketing authorisation of the sickle cell disease medicine Oxbryta remain suspended. This recommendation follows interim measures taken by the Committee in September 2024, when it temporarily suspended the medicine to review emerging safety data.

And finally…

We hope that our readers find our reviews to be both informative and helpful in keeping up to date with pharmaceutical legislation and regulatory guidance.

Further information on these and other topics can be found in recent versions of the “Regulatory Update” on the PHSS website (members area) by utilising the hyperlink within that particular Update.

GMP Update is compiled by Malcolm Holmes C.Chem. MRSC, a member of the PHSS Management Committee.