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Updated: 6 days ago

Review of Developments in GMP and the Regulation of Medicines March 2026

EJPPS Volume 31.1C

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, USA Swiss & PIC/S regulatory authorities.

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

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

  • MHRA Guest Blog- Mila to Millions (by Julia Vitarello) : A New Era of Individualized Medicines

  • Public advised to stop using some non-sterile alcohol-free wipes

  • Consultation on indefinite recognition of CE-marked medical devices

  • UK medical device testing hits record high as MHRA backs growth in brain and AI technology

  • Fake Mounjaro (tirzepatide) KwikPen 15mg pre-filled pens

  • Regulation as an Enabler of Innovation: A Regional Perspective – guest blog

 

EU

European Medicines Agency (EMA)

  • Concept paper on the revision of the guidelines on GMP for medicinal products - Annex 15- Qualification and Validation

  • CAT workplan 2026 (Adopted by the committee on 23 January 2026)

  • Drug Shortages Global Regulatory Working Group

  • EMA recommends withdrawal of marketing authorisations for levamisole medicines

  • Summary notes of the HMA-EMA group focused on AI with industry stakeholders meeting

  • Quality Innovation Group (QIG): Listen and learn focus group meeting on sustainability

 

 

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

  • Reference Standards

  • Certification monthly report of activities: End of January 2026

 

 USA

The US Food and Drug Administration (USFDA)

  • Certification Process for Designated Medical Gases


International

Switzerland

Swissmedic

  • Swiss Pharmacopoeia

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

  • Concept paper on the revision of EU-PIC/S GMP Annex 15 (Qualification and validation)

  • Concept paper on the revision of EU-PIC/S GMP Annex 6 - Manufacture of medicinal gases

  • PIC/S membership


Products

• MHRA approves zapomeran (Kostaive) mRNA COVID-19 vaccine

• MHRA - Brensocatib licensed as the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis in patients 12 years and older

• MHRA - zanidatamab (Ziihera) for the treatment of biliary tract cancer

• MHRA - imlunestrant tosylate (Inluryo) - a new treatment for breast cancer

• New single-dose oral treatment for human African trypanosomiasis (sleeping sickness)


Papers

AEGSP, EFPIA and medicines for Europe

  • Digital Medicines Information gains momentum

 

RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS

 

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA Guest Blog- Mila to Millions (by Julia Vitarello) : A New Era of Individualized Medicines

In the MHRA foreword to this Blog, Lawrence Tallon, Chief Executive of the MHRA, states:-

“Mila’s story is one of the most powerful you will ever read. It is both heart-breaking and also inspiring when you learn how her mother, Julia, has turned her own personal tragedy into a global mission to save millions of other children and their families from going through similar ordeals in the future. Where she finds the strength, we will never know, but it surely demonstrates the power of a mother’s love and her determination to create a legacy to change the world in Mila’s name. We were privileged to have Julia speak to our leadership team at the MHRA, which was both deeply moving and also energising. It provided us with even more motivation and drive to put patients with rare and ultra-rare diseases at the heart of our work and to ensure the UK leads the way in bringing the new possibilities of gene therapies to those patients safely and expediently, and that this country can be a torchbearer for others to follow”.

[Its great to see how patient and carer input can lead to medical advancement. Also to see MHRA and our industry taking a lead in these medical advances.

Note: PHSS issued this item as an Impact Statement to members on 3 Feb 2026..]

Public advised to stop using some non-sterile alcohol-free wipes

UKHSA and MHRA are reminding the public not to use 4 specified non-sterile alcohol-free wipe products due to the risk of infection associated with their use. There have been 59 confirmed cases of Burkholderia stabilis associated with some non-sterile alcohol-free wipe products - identified in an outbreak in the United Kingdom from January 2018 to 3 February 2026. A small number of cases continue to be detected. These have included some serious infections which have required hospital treatment and 1 death has been attributed to Burkholderia stabilis infection.

During outbreak investigations in 2025, the following products were found to be contaminated with Burkholderia. These four products should not be used under any circumstances:

  • ValueAid Alcohol Free Cleansing Wipes

  • Microsafe Moist Wipe Alcohol Free

  • Steroplast Sterowipe Alcohol Free Cleansing Wipes

  • Reliwipe Alcohol Free Cleansing Wipes (testing revealed contamination with a Burkholderia strain not related to the outbreak cases)

The MHRA issued notices to the sellers of these products in July, resulting in their withdrawal from sale. However, some of these products may still remain in some first aid kits and in people’s homes.

Consultation on indefinite recognition of CE-marked medical devices

Around 90% of medical devices currently used in Great Britain are CE marked, and the proposals for indefinite recognition would ensure consistent long-term supply to support the health system. The consultation seeks feedback on the proposals to extend arrangements put in place in 2023 to recognise CE marked devices, and forms part of the MHRA’s wider programme of regulatory reform of medical devices, designed to be risk-proportionate, pro-innovation and patient-focused.

UK medical device testing hits record high as MHRA backs growth in brain and AI technology

UK patients could be among the first in the world to benefit from breakthrough medical devices, as clinical investigations reach their highest level on record in 2025. New figures from the MHRA show a 17 per cent rise in approved clinical investigations compared with last year, as companies increasingly choose Great Britain to test cutting-edge health technologies. At the same time, the MHRA is rolling out new measures to back innovation and remove barriers for smaller companies, including a fee waiver pilot, early market access to promising devices, and enhanced support for high-impact technologies.

The growth reflects a global race to tackle some of the most challenging health conditions. Dementia, Parkinson’s disease and epilepsy are driving huge investment in neurotechnology, with studies in this area doubling since 2024 to make up around a quarter of all UK applications. I-powered medical devices are also surging, including tools that scan medical images to spot disease earlier, guide treatment decisions and personalise care. New studies include digital tools that adjust treatment in real time, such as an app to help people with chronic obstructive pulmonary disease manage their condition, while giving clinicians better information to personalise treatment.

Companies are looking for speed, certainty and expertise, and this is the offering from the UK. The MHRA has met 100 per cent of its statutory deadlines for clinical investigation applications since September 2023, with average approval times for clinical investigations in 2025 at 51 days, running nine days faster than the 60-day target. To build on this momentum, the MHRA is now rolling out a package of measures designed to back the most innovative technologies and cut barriers for smaller companies. From January 2026, the MHRA has waived fees for micro and small UK firms in a pilot scheme.

Fake Mounjaro (tirzepatide) KwikPen 15mg pre-filled pens

As a precautionary measure, the MHRA is contacting certain individual patients to make them aware of a small possibility that they may have been dispensed a fake Mounjaro (tirzepatide) KwikPen 15mg solution for injection for weight-loss management from The Private Pharmacy Clinic in Birmingham.

All the affected fake pens identified to date are 15mg pens with the batch number: D873576 dispensed by this pharmacy.

This is a legitimate batch number for genuine Mounjaro KwikPen 7.5mg, and pens at this strength are not impacted.

Testing has confirmed that the identified fake pens do contain tirzepatide, the active substance in Mounjaro, but because the manufacturing conditions are unknown, MHRA cannot confirm that the contents are sterile.

Regulation as an Enabler of Innovation: A Regional Perspective

Innovation and regulation work best together—enabling new solutions to be adopted quickly while upholding the highest standards of protection and trust.

As outlined by Richard Stubbs in the next MHRA’s blog series, artificial intelligence shows both the immense opportunity and the need for responsible oversight. AI can transform care, but only when developed with rigour, transparency and fairness. There is a tendency to frame regulation as a brake on innovation. In practice, good regulation does the opposite. By setting clear standards, providing proportionate oversight and adapting to emerging technologies, regulators create the conditions in which innovation can be developed, tested and adopted at pace. Nowhere is this more important than in the rapidly evolving field of artificial intelligence, and specifically within healthcare. As the Health Secretary said earlier this month, “moving too slowly” in the shift from analogue to digital in the NHS risks “locking inefficiency into the system while demand continues to rise”. AI has enormous potential to improve patient outcomes, support the workforce and drive productivity across health and care. But that potential will only be realised if these technologies are safe, effective and equitable. This is why the work of the National Commission into the Regulation of AI in Healthcare is so important. The commission’s role in shaping a coherent, future-focused regulatory approach sends a strong signal that artificial intelligence is an essential component of how we create a sustainable, personalised NHS of the future where staff and patients are supported and empowered by groundbreaking technology. And it also makes it just as clear that, of course, it must be responsible.


Europe

European Medicines Agency (EMA)

Concept paper on the revision of the guidelines on GMP for medicinal products - Annex 15- Qualification and Validation

Annex 15 is currently intended to be used by active substance manufacturers as an optional supplementary guidance to the requirements already outlined in EudraLex, Volume 4, Part II. The proposal is to extend the scope of the annex to active substance (AS) manufacturers and amend the text in selected areas supplementing and linking with guidance provided in EudraLex, Volume 4, Part II and other guidance relating to active substances (e.g. GDP)

The EMA GMP/GDP Inspectors Working Group and the PIC/S Sub-committee on GMDP Harmonisation jointly recommends that the current version of Annex 15, Qualification and validation, be revised according to this concept paper.

The comment period ends 9 April 2026

CAT workplan 2026 (Adopted by the committee on 23 January 2026)

For 2026, CAT will focus on the provision of scientific and regulatory guidance and training. In horizontal activities CAT will contribute the ATMP-specific perspective, supporting other Committees and decision makers.

While specific topics are singled out in the workplan, important other activities will continue, such as communication within the network, exchange with international regulators, identifying regulatory challenges for ATMPs and initiating potential paths to solutions, monitoring new legislations for their impact on the ATMP field, participating in scientific conferences to spread regulatory knowledge and interaction with stakeholders in general.

The CAT will continue its responsibilities in supporting the development and authorisation of ATMPs, and will work to embedding ATMP expertise in the future regulatory framework.

Drug Shortages Global Regulatory Working Group

The Drug Shortages Global Regulatory Working Group is an international forum of medicine regulators and the WHO, established to share information about medicines’ shortages with a global impact and the actions taken by each jurisdiction to prevent, mitigate, and monitor the impact of these shortages. In addition, relevant policy measures and best practices to address shortages are discussed.

Recently, the Working Group established a subgroup to specifically address shortages of GLP-1 receptor agonists. Other subgroups may be created to facilitate specific discussions deemed necessary by the Working Group.

EMA recommends withdrawal of marketing authorisations for levamisole medicines

This follows an EU-wide review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic worm infections in adults and children.

The review confirmed that leukoencephalopathy is a rare but serious side effect of levamisole. The information reviewed by PRAC showed that leukoencephalopathy can occur after a single dose of levamisole and that symptoms may develop up to several months after treatment. The review did not identify any measures to reduce the risk or any group of people who may be at higher or lower risk. In addition, other medicines are authorised in the EU for the treatment of parasitic worm infections. Given that levamisole medicines are used to treat mild parasitic worm infections, and that levamisole-induced leukoencephalopathy is a serious condition with an unpredictable onset, PRAC concluded that the benefits of levamisole medicines no longer outweigh the risks and recommended that their marketing authorisations be withdrawn in the EU.

Summary notes of the HMA-EMA group focused on AI with industry stakeholders meeting

An update on the activities related to the EMA and FDA collaboration on AI guiding principles and terminology was noted. Industry welcomed the work on AI principles and terminology and praised the international collaboration underpinning it. Industry participants highlighted the importance of expanding collaboration beyond EMA and FDA and sought clarity about long-term strategic intentions for international harmonisation.

EMA confirmed that AI principles were drafted to apply to both human and veterinary domains and acknowledged the need for clear communication on this point.

Quality Innovation Group (QIG): Listen and learn focus group meeting on sustainability

The QIG) is organising a listen-and-learn focus group (LLFG) meeting with representatives from academia and industry on innovative technologies to advance sustainability goals in pharmaceutical manufacturing.

The purpose of this LLFG is to understand and discuss with stakeholders their advanced manufacturing and quality control approaches for integrating sustainability into pharmaceutical development, manufacture and supply chain processes.

During the meeting, stakeholders, academia and industry, will discuss with QIG members and additional European regulatory experts how innovative technologies can be developed and implemented to achieve more sustainable pharmaceutical manufacturing. They will talk about any scientific and/or regulatory challenges and identify possible solutions to address them.

 

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

Reference Standards

3 new European Pharmacopoeia reference standards and 17 replacement batches released in January 2026

Certification monthly report of activities: End of January 2026

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.


United States of America

The US Food and Drug Administration (USFDA)

Certification Process for Designated Medical Gases

This draft guidance explains how FDA administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs). Specifically, the guidance discusses what products qualify as DMGs, who must submit a certification request, what information must be submitted, and how FDA will evaluate and act on the request. This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance of the same name issued in November 2015, which was withdrawn on December 18, 2025.

Comments should be provided by 13 April 2026.

 

International

Switzerland

Swissmedic

Swiss Pharmacopoeia

Since 1865, the Swiss Pharmacopoeia has been a synonym for the quality, safety and uniformity of medicinal products. What started as a Latin recipe book for pharmacists is now, in combination with the European Pharmacopoeia, a mandatory reference work and cornerstone of Swiss medicinal product regulation. The pharmacopoeia’s role changed with the arrival of industrialisation, when production shifted to pharmaceutical companies and the importance of state inspections increased. As a result it became mandatory for pharmacies, the industry and regulatory authorities and is now a legally enshrined compendium of quality specifications.

The foundation in Switzerland is provided by the European Pharmacopoeia (Ph. Eur.), supplemented by the Ph. Helv. This latter publication is used where European regulations do not cover areas specific to Switzerland, such as traditional preparations and herbal medicinal products.

The Ph. Helv. is constantly updated to reflect the current state of science and technology. It is Swissmedic’s responsibility to ensure that pharmacopoeia standards are defined, kept up-to-date and implemented in real-world practice.

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

Concept paper on the revision of EU-PIC/S GMP Annex 15 (Qualification and validation)

The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 15 (Qualification and validation) of the EU - PIC/S GMP Guide. This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 15 - Qualification and validation, of the Good Manufacturing Practice (GMP) Guide, that is common to the Member States of the European Union (EU) / European Economic Area (EEA), as well as to the Participating Authorities (PAs) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).The aim of the revision is to extend the scope of the annex to active substances manufacturers and to consider the revision of ICH Guideline Q9 (R1) on quality risk management.

Concept paper on the revision of EU-PIC/S GMP Annex 6 - Manufacture of medicinal gases

The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 6 (Manufacture of medicinal gases) of the EU-PIC/S GMP Guide.

This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 6 - Manufacture of medicinal gases, of the Good Manufacturing Practice (GMP) Guide, that is common to the Member States of the European Union (EU) / European Economic Area (EEA), as well as to the Participating Authorities (PAs) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

The aim of the revision is to carry out a limited review and update of the guideline to reflect industry’s current practices, including the use of new technologies and computerized systems.

PIC/S membership

Kazakhstan applies for PIC/S membership &

Ghana applies for PIC/S pre-accession.

 

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]

 

MHRA approves zapomeran (Kostaive) mRNA COVID-19 vaccine

Zapomeran is given as a single 0.5 mL booster dose by injection into the muscle of the upper arm. It contains a self-amplifying messenger RNA (sa-mRNA) which instructs the body’s cells to temporarily make the SARS-CoV-2 spike protein. This teaches the immune system to fight off the virus in the future.

The approval was granted on 2 January 2026 under the International Recognition Procedure (IRP). The Reference Regulator was the European Medicines Agency (EMA)

MHRA - Brensocatib licensed as the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis in patients 12 years and older

MHRA has granted a marketing authorisation for the medicine brensocatib (Brinsupri) to treat patients 12 years and older with non-cystic fibrosis bronchiectasis (NCFB) who have experienced two or more flare-ups or worsening of symptoms in the past 12 months.

NCFB is a chronic, long-term condition where the airways of the lungs are damaged, causing a cough with mucus production. It can affect anybody but is more common in older adults.

Brensocatib is available as a tablet to be taken by mouth once a day.

The marketing authorisation was granted to Insmed Netherlands B.V.

MHRA - zanidatamab (Ziihera) for the treatment of biliary tract cancer

MHRA has approved zanidatamab (Ziihera) for use in adults to treat biliary tract cancer (cancer of the structures that store and transport bile) whose cancer has high levels of a protein called HER2 and has progressed after previous treatment.

Zanidatamab is used when the cancer cannot be removed by surgery and has spread to nearby tissues or other parts of the body.

Zanidatama is administered by a infusion drip into a vein every two weeks.

A study in 80 patients with locally advanced or metastatic biliary tract cancer that could not be removed by surgery found that, among the 62 patients with high levels of HER2, the cancer shrank or was no longer detectable in around 52% of patients after an average follow-up of 34 months. The study did not compare Ziihera with placebo or another cancer medicine.

Approval was granted to Jazz Pharmaceuticals Research UK Limited. This product was submitted and approved via the International Recognition Procedure.

MHRA - imlunestrant tosylate (Inluryo) - a new treatment for breast cancer

MHRA has approved imlunestrant tosylate (Inluriyo), a new treatment for adult patients with a certain type of breast cancer that is locally advanced or has spread to other parts of the body (metastatic) and hasn’t responded, or has progressed further, following at least one line of hormonal treatment.

It is used when the cancer cells have oestrogen receptors (ER-positive) and do not have many receptors called human epidermal growth factor receptor 2 (HER2-negative).

Inluriyo can only be used in patients who have certain changes (mutations) in a gene called ESR1.

Imlunestrant tosylate is taken as a daily tablet. The new marketing authorisation was granted to Eli Lilly Nederland B.V.

New single-dose oral treatment for human African trypanosomiasis (sleeping sickness)

EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Acoziborole Winthrop for the treatment of human African trypanosomiasis (HAT; sleeping sickness) caused by Trypanosoma brucei gambiense (g-HAT).

Acoziborole Winthrop is intended for use outside the European Union (EU) and was assessed under the EU-M4all programme.

Following concerted efforts to control g-HAT, transmission has been eliminated in many countries. Fewer than 1,000 cases are now reported annually on the African continent. However, the disease is usually fatal without treatment and current therapies are complex.

Acoziborole Winthrop is given as a single oral dose and is effective in all stages of g-HAT, removing the need for lumbar puncture and hospitalisation. This simplifies treatment for patients, facilitating compliance and accessibility.


Papers

AEGSP, EFPIA and medicines for Europe

Digital Medicines Information gains momentum

Europe is moving towards a digital future for medicines information. A new report provides a comprehensive overview of electronic Product Information (ePI) pilot projects across 31 countries. The findings reveal a landscape of innovation, collaboration, and cautious optimism as countries prepare to move from paper-based patient leaflets to digital solutions, aligned with the revision of the European pharmaceutical legislation.

This report is a detailed resource on ePI pilots in Europe, providing valuable insights for policymakers, healthcare professionals, and industry stakeholders.

AESGP, EFPIA and Medicines for Europe reaffirm their commitment to working with all stakeholders to drive the successful rollout of ePI across Europe.

 

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.

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

 






 
 
 

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