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

EJPPS Volume 31.1B

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INTRODUCTION

This month reported issues have come from the UK, EU, USA PIC/S and Swiss regulatory authorities.

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

• MHRA strategy blog series

• Regulation of AI in Healthcare Open call for evidence

• Strengthening dependency and addiction warnings on medicines used to treat pain, anxiety, and insomnia

• Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation

• MHRA statement on new review of paracetamol safety during pregnancy

• Isotretinoin prescribing requirements updated with revised risk-minimisation measures

• MHRA seizes illegal medicines worth almost £45m in 2025

EU

European Medicines Agency (EMA)

• EMA press briefing on human medicines in 2025

• EMA and FDA set common principles for AI in medicine development

• 3-year rolling work plan for the Quality Innovation Group (QIG)

• Use of paracetamol during pregnancy unchanged in the EU

• Guideline on the pharmaceutical quality of inhalation and nasal medicinal products

• QWP Q&A: how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV)

• Q&A regarding co-processed excipients used in solid oral dosage forms

• Quality of medicines Q & A: Part 2

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

• Pharmeuropa 38.1

• Reference standards

• Certification monthly report:

• European Pharmacopoeia Issue 12.3

• Ph. Eur. general chapter on Quality of data

• Isoniazid 50 mg/mL oral solution monograph published in European Paediatric Formulary

• European Paediatric Formulary: Amlodipine 0.5 mg/mL oral solution monograph in public consultation

• NEW FAQ on how to present the specification for a substance in a CEP application

• Implementation of the European Pharmacopoeia Issue 12.3 – Notification for CEP holders

• European Pharmacopoeia Commission (EPC) clarifies rFC integration and future innovation pathways

• Clarification on the use of the sister file procedure

USA

The US Food and Drug Administration (USFDA)

• M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

USP-NF

• 〈382〉 Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems. (Revision Bulletin)

• 〈661〉 Plastic Packaging Systems and Their Materials of Construction ( Revision Bulletin)  

International

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

Jordan / JFDA joins PIC/S

Switzerland

Swissmedic

• Updating of Annex 7 TPLRO – Revised list of variations

• Product information for veterinary medicinal products and Packaging texts for veterinary medicinal products

• Reassessment of the safety of blood transfusions with regard to vCJD

• Scientific GMDP Meetings

Products

• EMA- Human medicines in 2025

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

• MHRA-Nirogacestat hydrobromide approved to treat desmoid tumours

Conferences / webinars etc

• EMA Product Management Service (PMS) information day 2026

• EDQM webinar on medicine supply status: understanding the new classification approach

• PHSS QRM and Process Risk Management for Annex 1 Compliance

• PHSS CMC and GMP, specific focus on Biologics and ATMPs

RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA strategy blog series

A series of articles from influential external voices about the challenges and opportunities ahead.

The MHRA plays a central role in shaping the future of health and life sciences. The agency’s upcoming five year plan, due to be published in 2026, is an important part of this – helping the agency to deliver on the ambitions of the government’s recent long-term plans for the NHS and life sciences sector.

To support the development of this upcoming five year strategy, the MHRA is publishing a series of blogs on the challenges and opportunities ahead. This series welcomes in important voices across academia, industry and the patient community to stimulate informed discussion on regulatory approaches that balance safety, innovation and trust.

Regulation of AI in Healthcare Open call for evidence

The MHRA is seeking evidence on the regulation of AI in healthcare to inform the recommendations of the National Commission into the Regulation of AI in Healthcare.

The Call for Evidence invites evidence and views on:

• whether the UK’s framework for regulating AI in healthcare is sufficient

• how the UK’s regulatory framework may need to be improved to ensure fast access to safe and effective AI medical devices

• approaches to checking safety once AI medical devices are in use

• how responsibility and liability are managed between different parties involved in the deployment of AI medical devices.

This call for evidence closed on 2 February 2026

Strengthening dependency and addiction warnings on medicines used to treat pain, anxiety, and insomnia

Updated product information and packaging will help patients better understand the risks of dependency, addiction, and withdrawal with these medicines. Following a comprehensive safety review by the MHRA, warnings on the packaging and patient information leaflets for gabapentinoids, benzodiazepines, and z-drugs are being strengthened to better inform patients and healthcare professionals of the risks of dependency, addiction, withdrawal, and tolerance.

Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation

The MHRA is now setting out the next phase of reforms for 2026, aimed at helping patients access new cutting-edge treatments more quickly and boosting the UK’s competitiveness for global clinical research.

The UK is ramping up efforts to become a global first choice for clinical trials, as new figures published today (13 January), show a sharp rise in activity in 2025, and changes coming this year including a fast-track route-that will help companies get studies up and running more quickly, so patients can benefit from new treatments sooner.

MHRA Data shows clinical trial applications received rose by 9 per cent between January and November 2025 compared with the same period in 2024. Growth was strongest in early and innovative research, where speed and expert regulatory support can make or break decisions on where companies invest.

Companies are also coming to regulators earlier for help. The number of MHRA scientific advice meetings provided on clinical trials rose by 75 per cent over that period, as developers seek to design trials right first time and avoid costly delays later on.

Alongside faster assessments, the new framework will support clearer, more agile routes to support innovation. This includes making better use of early safety data from overseas studies that meet UK standards, and new MHRA capability to assess computer model simulations, such as in-silico trials, to help predict how new medicines may behave before they are tested in patients. The aim is to reflect how modern medicines are developed today, without lowering safety standards.

MHRA statement on new review of paracetamol safety during pregnancy

Following publication of a new systematic review and meta-analysis, the MHRA has reaffirmed that paracetamol continues to be the safest option for managing pain and fever during pregnancy.

Isotretinoin prescribing requirements updated with revised risk-minimisation measures

Prescribing requirements for isotretinoin, a treatment for severe acne, are being updated by the MHRA to strengthen its ability to monitor safe prescribing while supporting patient access to treatment.

The updated approach follows independent advice from the Commission of Human Medicines (CHM) which carried out a review of the impact of the existing safety measures for the prescribing of isotretinoin. The review found that safety measures are working well, with healthcare professionals now spending more time discussing the benefits and risks of isotretinoin with patients and monitoring them more closely for side effects. However, the requirement for treatment of young people under 18 to be agreed by two-prescribers was found to be causing potential delays in access to treatment for some under-18s, with minimal evidence of disagreement between prescribers about treatment decisions. Given this evidence, the CHM has recommended that healthcare professionals can prescribe isotretinoin to under-18s without seeking the agreement of a second prescriber, ensuring young people with severe acne benefit from both safer and more timely access to treatment. This is in line with the approach taken by other international regulatory bodies.

MHRA seizes illegal medicines worth almost £45m in 2025 – disrupting major criminal networks

MHRA, working with law enforcement partners, seized almost 20 million doses of illegally traded medicines, with a potential street value of nearly £45 million, during 2025.

As part of a crackdown on criminal profits, the MHRA’s financial investigators also denied criminals access to more than £2.1 million in assets linked to the illegal trade in medicines.

The MHRA’s Accredited Financial Investigators are authorised by the National Crime Agency under the Proceeds of Crime Act 2002 (POCA). They support investigations by tracing, freezing, and confiscating assets linked to crime, including money laundering and the illegal supply of medicines.

[Individual operations have been reported in previous editions of the Update as they arose/ were declared by MHRA. It is good to note the recovery of some assets under the proceeds of crime act, though £2.1 million doesn’t appear a high percentage on 20 million doses of medicines with a street value of nearly £45 million, MBH]

Europe

European Medicines Agency (EMA)

EMA press briefing on human medicines in 2025

Join the EMA (Thursday, 15 January 2026, 13:00 - 13:45 GMT) for its first press briefing of 2026.

During the event, EMA will:

• provide an overview of key developments in human medicines during 2025;

• explore major trends in human medicines;

• spotlight advancements in therapies for endocrine and cardiovascular diseases (e.g., heart diseases, diabetes, weight management).

On the same day, EMA will also publish the Human medicines in 2025 report, offering a detailed review of these developments and trends.

The press briefing will be:

• held in English (no translations provided);

• streamed live on EMA’s U Tube and Linkedin channels.

EMA and FDA set common principles for AI in medicine development

EMA and the U.S. FDA have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle.

The principles give broad guidance on AI use in evidence generation and monitoring across all phases of a medicine, from early research and clinical trials to manufacturing and safety monitoring.

The principles are relevant for those developing medicines, as well as for marketing authorisation applicants and holders. They will underpin future AI guidance in the different jurisdictions and support enhanced international collaboration among regulators, organisations setting technical standards and other stakeholders. Guideline development in the European Union (EU) is already underway, building on the EMA AI reflection paper published in 2024.

3-year rolling work plan for the Quality Innovation Group (QIG)

Short-term strategic goals

To ensure the EU regulatory network is prepared to support innovation in manufacturing and control of medicines, the main focus of the group will be to continue the work on pharmaceutical process models including artificial intelligence (AI) considerations, digitalization, 3D printing, platform technologies, personalised medicines, continuous manufacturing (CM) (particularly end- to-end CM and CM for biologicals), and decentralised manufacturing (DCM). A future area the group is starting to work on is advanced manufacturing technologies enabling pharmaceutical sustainability.

Long-term strategic goals

Future topics the group is considering working on include 3D bioprinting, Artificial Intelligence, automation and robotics, supporting novel regulatory concepts in line with pharma legislation (e.g. decentralised manufacturing (DCM), platforms), Bioinformatics, Next Generation Sequencing (NGS), traceability for personalized medicines, and analytical innovation as experience evolves.

Use of paracetamol during pregnancy unchanged in the EU

Update as of 20 January 2026. Recent publication confirms no increased risk of autism, ADHD or intellectual disability.

A recent systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology, & Women’s Health has found no evidence that using paracetamol at recommended doses during pregnancy increases the risk of autism spectrum disorder, ADHD or intellectual disability in children. This supports the existing evidence and advice that the EMA issued on the use of paracetamol during pregnancy.

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products

This guideline replaces the guideline on pharmaceutical quality of inhalation and nasal products and Quality of medicines Q&A: Part 2 Specific type of products – Dry product inhalers; Orally inhaled products; Storage – What are the requirements for storage orientation recommendations in the product information for pressurised metered dose

inhalers.

The main aim of the first revision is to consolidate the information available in the previous guidance documents, the related published Q&A, also taking into consideration recent advancements in the field, common practice and new regulations, including the medical device regulation. Requirements for demonstration of therapeutic equivalence for orally inhaled products (OIP) are included in the Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD).

These two guidelines are complementary and should be read in conjunction to each other.

Effective date 1 Feb 2026.

QWP Q&A: how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV)

The CEP procedure is widely used in EU for submission of pharmacopoeial active substance manufacturer data.

Based on experience gained by National Competent Authorities (NCA) and the extensive use of CEPs in MAA/MAV, it has become apparent that some aspects of Marketing Authorisation Holders (MAH)/applicant responsibilities need to be elucidated.

This document aims to clarify existing guidance as a compilation of required data to be submitted in a MAA or in certain MAVs when a CEP is referred to in the MA dossier. It is also applicable when an excipient covered by a CEP is used as an active substance (AS).

Even if several aspects of this document would equally apply to ASMFs and when full information on active substance is provided in the MA dossier, the focus of this Q&A is on CEPs.

Q&A regarding co-processed excipients used in solid oral dosage forms

The document outlines the quality requirements for co-processed excipients (CoPE) used in solid oral dosage forms in both human and veterinary medicinal products. The use of CoPEs in pharmaceutical formulations can present a higher degree of risk than using individual excipients due to several factors: for example complexity of composition, quality control, formulation development and stability issues. The Q&A aims to harmonise and clarify dossier requirements for CoPEs using a risk-based approach. It defines three risk categories for the CoPE and the risk factors the MAH/applicant should consider to identify the adequate risk category, and the related quality dossier requirements, which need to be provided by the MAH/applicants as part of new MAA or variations.

On 28 Jan 2026 the section regarding Overview of Comments Received was published.

Quality of medicines Q & A: Part 2

Updated 30 January 2026

'EMAs Quality Working Party (QWP) Q&A to provide technical and procedural guidance on the use of titanium dioxide (TiO2) as colourant in medicines' section.

Updated on 28 January 2026

Administrative changes implemented to ensure alignment with the revised variations classification framework.

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

Pharmeuropa 38.1

Pharmeuropa 38.1 has just been released. The deadline for comments is 31 March 2026.

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 38.1.

Reference standards

5 new European Pharmacopoeia reference standards and 16 replacement batches were released in December 2025

Certification monthly report of activities: End of December 2025

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

European Pharmacopoeia Issue 12.3

The European Pharmacopoeia (Ph. Eur.) Issue 12.3 is now available and will be applicable in 39 European countries as of 1 July 2026.

New Ph. Eur. general chapter on Quality of data

Ph. Eur. has published a new general chapter on Quality of data (5.38) in Issue 12.3, following its adoption by the European Pharmacopoeia Commission at its 182nd session in June 2025.

Published for information, this chapter addresses the quality of data, with a particular focus on data of digital origin. It complements existing Ph. Eur. chapters that support digital and technological transformation in the pharmaceutical sector

General chapter 5.38 provides a framework for managing digital data quality across its entire life cycle. It introduces:

• general concepts of data, data governance and quality dimensions, such as accuracy, bias, completeness and reproducibility;

• the Extract-Transform-Load (ETL) process as a framework for managing data throughout its life cycle;

• the role of subject matter experts (SMEs) in ensuring data is fit for purpose, especially when used in automated decision-making systems;

• an overview of data sources (e.g. sensors, databases and cloud platforms) and data formats for storage, including open formats.

This new chapter is a significant step in the Ph. Eur.’s adaptation to the evolving digital landscape.

Isoniazid 50 mg/mL oral solution monograph published in European Paediatric Formulary

Isoniazid 50 mg/mL oral solution, the 11th PaedForm monograph developed by the European Paediatric Formulary (PaedF) Working Party, has been published in the European Paediatric Formulary following public consultation on the draft. The monograph describes an age-appropriate oral formulation used in the treatment or prevention of tuberculosis. The need for paediatric formulations of this medicinal product was highlighted by the EMA in 2013, and no licensed age-appropriate products are currently available in most member states.

The formulation of the isoniazid 50 mg/mL oral solution covered by the monograph is based on a formulation published in the Spanish National Formulary and was selected because it was supported by a validated test method and stability data, both of which were provided by the University of Seville.

European Paediatric Formulary: Amlodipine 0.5 mg/mL oral solution monograph in public consultation

Amlodipine, a calcium channel blocker, can be used in paediatric populations for the treatment of hypertension. Although the need for age-appropriate formulations of this medicinal product was highlighted by the European Medicines Agency (EMA) in 2013, no licensed age-appropriate products are currently available in most member states.

The formulation described in the Amlodipine 0.5 mg/mL oral solution monograph was selected based on an existing unlicensed extemporaneous preparation developed in the Netherlands, this formulation is supported by validated test methods and stability data provided by the Erasmus Medical Centre in Rotterdam and by the Laboratory of the Dutch Pharmacists (LNA). The strength of the preparation, 0.5 mg/mL, yields a stable oral solution in simple syrup with methyl parahydroxybenzoate.

The deadline for comments is 31 March 2026.

New FAQ on how to present the specification for a substance in a CEP application

This resource provides clear, consolidated guidance for the preparation of section 3.2.S.4.1 of CEP dossiers and should be used for all future submissions.

The FAQ should be read in conjunction with the EDQM guideline “Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use” PA/PH/CEP (04) 1, 7R.

Implementation of the European Pharmacopoeia Issue 12.3 – Notification for CEP holders

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 July 2026

European Pharmacopoeia Commission (EPC) clarifies rFC integration and future innovation pathways

This milestone reinforces the commitment of the EDQM and of the EPC to patient safety, scientific rigour and sustainability under the 3Rs principle (replace, reduce, refine) and provides another valid alternative for users now that the rabbit pyrogen test has been suppressed (as of 1 January 2026).

To support stakeholders during the transition to rFC, the EDQM has published a comprehensive FAQ addressing common questions about rFC inclusion and future developments. The EDQM also clarifies its position on recombinant cascade reagents (rCR): while promising, these methods are still in the data-generation phase.

Clarification on the use of the sister file procedure

The current EDQM Guidance on applications for “sister files””, has guided the sister file procedure for CEPs for many years.

Experience gathered over time indicates that there may be discrepancies in the understanding of the procedure and the EDQM has noted that certain CEP applications are being submitted under the sister file procedure even though their characteristics would more appropriately classify them as new applications.

To reinforce clarity, avoid misclassifications and ensure consistency, the EDQM will implement the following measures:

Stricter screening of requests for sister file applications at reception

The EDQM will revise the “Guidance on applications for “sister files" in 2026.

The stricter screening of sister file applications as highlighted above is scheduled to begin on 1 February.

United States of America

The US Food and Drug Administration (USFDA)

M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

FDA is announcing the availability of this draft guidance for industry

The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to establish a globally harmonized framework to organizing and presenting quality data included in registration applications for medicinal products for human use. The draft guidance updates the quality section of the common technical document (CTD) to further improve registration and life cycle management efficiency, facilitate digitalization and knowledge management, and support provisions for emerging technologies.

Comments should be provided by 23 March 2026.

USP-NF

〈382〉 Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems. (Revision Bulletin)

Comments were received indicating that a revision is needed to the Needle Self-Sealing Capacity test requirement to penetrate elastomeric closures 1.5 times. It was noted that this differs from ISO 11608-3, which specifies only 1.0 penetrations. Applying the USP requirement could result in excessive punctures—up to 252 for one cartridge product—which may lead to leak test failures, even though such usage does not reflect typical patient behavior.

To resolve this, USP will revise the requirement to specify 1.0 penetrations as the maximum number of scheduled punctures.

〈661〉 Plastic Packaging Systems and Their Materials of Construction ( Revision Bulletin)

The General Chapters Packaging and Distribution Expert Committee has revised the <661> Plastic Packaging Systems and Their Materials of Construction general chapter.

With the development of <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use, the intent has been that, once these chapters become official, the test methods and acceptance criteria currently found in <661> would be omitted because they would be redundant to the requirements established in <661.1> and <661.2>.

Therefore, the purpose of this revision is to remove the test methods and acceptance criteria that arecurrently published in <661> to ensure stakeholders do not continue to use outdated methods and criteria that are no longer applicable.

The <661> Revision Bulletin supersedes the currently official general chapter.

International

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

Jordan / JFDA joins PIC/S

On 1 January 2026, the Jordan Food & Drug Administration (JFDA) became the 57th PIC/S Participating Authority.

Switzerland

Swissmedic

Updating of Annex 7 TPLRO – Revised list of variations

The lists published by Swissmedic, incl. Annex 7 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO; SR 812.212.22) have been revised and amended.

A need for revision, particularly of Annex 7 TPLRO, was identified on the basis of the collected reports and in keeping with the requirements and specifications of EU legislation.

Up until 31 January 2026, variations and extensions for human medicinal products must be submitted using the existing form (valid until 31 January 2026) and, from 1 February, using the new form (valid from 1 February 2026).

Product information for veterinary medicinal products and Packaging texts for veterinary medicinal products

With effect from 1 January 2026 a printed package leaflet can be dispensed with in future for veterinary medicinal products for use exclusively by veterinarians – a QR code on the packaging links directly to the Information for healthcare professionals., it will be possible to dispense with a paper copy of the package leaflet for certain veterinary medicinal products.

The Information for healthcare professionals will not need to be enclosed with veterinary medicinal products that are used exclusively by veterinarians and not dispensed to animal owners, provided that a QR code giving direct access to the Information for healthcare professionals is placed on the outer packaging.

Reassessment of the safety of blood transfusions with regard to vCJD

New blood donation criteria from Swiss Transfusion SRC effective 1 February 2026

Based on the evidence now available, Switzerland – like other countries – carried out a comprehensive reassessment of the existing donor deferral criteria by an expert group comprising specialists in transfusion medicine and infectious diseases. Following a request from Swiss Transfusion SRC and taking the expert group’s recommendation into account, Swissmedic agreed to the following revision:

The general deferral for blood donation is being lifted for people who:

• have received a blood transfusion in the past

• spent extended periods of time in the United Kingdom between 1980 and 1996

• have undergone a neurosurgical procedure in Switzerland

• received dental implants in Switzerland after 1993

Scientific GMDP Meetings

Swissmedic offers companies that hold, or are in the process of applying for, a Swissmedic establishment licence the opportunity to discuss project-specific questions related GMP and GDP within the framework of a Scientific GMDP Meeting. The aim of these meetings is to clarify regulatory requirements and expectations at an early stage in connection with planned projects, extensions or amendments to establishment licences. This approach supports consistent implementation of legal requirements and facilitates efficient execution of projects.

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]

EMA- Human medicines in 2025

The overview of the 2025 key recommendations includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.

In 2025, EMA recommended 104 medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before. This includes medicines representing important innovation or contribution to public health, such as the first medicine to treat non-cystic fibrosis bronchiectasis, a first-in-class treatment to delay the onset of stage 3 type 1 diabetes in children and adults, and the first oral medicine to treat postpartum depression following childbirth.

EMA also recommended 16 medicines for rare diseases and adopted three positive opinions for medicines for use in countries outside the EU, including a medicine for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents.

There were also 41 recommendations for new biosimilar products.

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-Nirogacestat hydrobromide approved to treat desmoid tumours

MHRA has approved the medicine Nirogacestat hydrobromide (Ogsiveo) for the treatment of progressing desmoid tumours in adults.

Desmoid tumours are tumours that form in connective tissue in the body, usually the arms, legs or abdomen. Whilst they are not cancerous, as they grow, they can cause damage in nearby tissue and become difficult to remove.

Nirogacestat hydrobromide may cause harm to an unborn baby if taken during pregnancy. It is uncertain how it may damage ovaries and testicles, and how it may affect men and women’s fertility. Therefore, nirogacestat hydrobromide must not be taken during pregnancy, and highly effective contraception must be used.

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

Ogsiveo is developed and commercialized by SpringWorks Therapeutics, a biopharmaceutical company that became a wholly-owned subsidiary of Merck KGaA

Conferences

Product Management Service (PMS) information day 2026

The third edition of the Product Management Service (PMS) info day is designed to provide interested stakeholders with a clear understanding of the strategic direction of PMS and how it contributes to the broader Network objectives.

The event will start Tuesday, 09 June 2026 , 08:00 - 12:00 British Summer Time (GMT+1)

with a public session from 9:00 to 13:00

aiming to:

• present the strategic direction of PMS and how we will reach the desired target;

• present the activities currently being undertaken by the network to support PMS implementation;

• show how all initiatives come together, including a high-level view of the PMS system.

This public session will be followed by afternoon discussions exclusively for on-site attendees at EMA premises.

EDQM webinar on medicine supply status: understanding the new classification approach

The EDQM will host a live webinar on 3 March 2026 (10:00 to 12:00, CET) to present its new assessment approach for classifying medicines as prescription or non prescription.

This event offers a unique opportunity for stakeholders to gain first hand insight into a rapidly evolving area of public health regulation.

This free event is designed for health authorities, policy makers, the pharmaceutical industry, pharmacists, doctors, prescribers, patients and academics interested in medicines regulation.

PHSS-Quality Risk Management and Process Risk Management for Annex 1 Compliance

This immersive one-day seminar builds on the foundational insights from the PHSS webinar "QRM and PRM for Annex 1 Compliance". It offers a hands-on, expert-led exploration of QRM and PRM principles, with a focus on their application in sterile and advanced therapy medicinal product (ATMP) manufacturing.

Date: Tuesday 10 February 2026. Location: Bristol, UK

PHSS-Chemistry, Manufacturing, and Controls (CMC) and Good Manufacturing Practice (GMP), with a specific focus on Biologics and Advanced Therapy Medicinal Products (ATMPs)

This two-day intensive workshop is designed to provide a deep dive into the critical aspects of CMC and Good Manufacturing Practice GMP, with a specific focus on Biologics and ATMPs.

This workshop is ideal for professionals in regulatory affairs, quality assurance, CMC development, and biomanufacturing operations who are navigating the complexities of bringing advanced therapies to market.

This is a new PHSS Training Course and will be held at Heathrow on : 24–25 Feb 2026

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.