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

EJPPS Volume 31.1A

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INTRODUCTION

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

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

• UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough health technologies

• Strengthening collaboration between the MHRA and the Department of Health Northern Ireland

• Updated guidance on the Health Institution Exemption to support safe use of medical devices

• MHRA seeks input on AI regulation at ‘pivotal moment’ for healthcare

EU

European Medicines Agency (EMA)

• Minutes of the 129th meeting of the Management Board

• EMA Management Board: highlights of December 2025 meeting

• Draft Guideline on quality of radiopharmaceuticals

• Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals

• EMA welcomes political agreement on new EU pharmaceutical legislation

• Guidance on GMP and GDP Q&A

• Q&A for applicants, marketing authorisation holders of medicinal products and notified bodies regarding medicines used in combination with medical devices and consultation procedures for certain medical devices

• Guideline on the Development and Manufacture of Synthetic Peptides

• Q&A for biological medicinal products

• Shortage Prevention Plan (SPP) and Shortage Mitigation Plan (SMP) pilot report

• Industry reporting via the ESMP during a crisis or MSSG-led preparedness action.

• European Shortages Monitoring Platform (ESMP): Interoperability with national and pharmaceutical industry systems

• Q&A for biological medicinal products

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

• Certification monthly report of activities.

• Ph. Eur. publication schedule evolves to better meet users’ needs

• 183rd session of the European Pharmacopoeia Commission (EPC)

• 1st Ph. Eur. individual monoclonal antibody medicinal product monograph

• Pharmacopoeial discussion group achievements

• EDQM reference standards monthly newsletter – November 2025

• Guideline on requirements for revision/renewal of certificates of suitability to the Ph. Eur.monographs

• A major step towards animal-free testing for the test for bacterial endotoxins

USA

The US Food and Drug Administration (USFDA)

• Q3E Guideline & supporting documentation for Extractables and Leachables

• Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products.

• Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the FD&C Act   

International

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

• Concept Paper - Revision of EU-PIC/S GMP Annex 3 (Radiopharmaceuticals)

Switzerland

Swissmedic

• Medicinal products containing the active substance paclitaxel as paclitaxel albumin

Products

• MHRA approves the first twice yearly biological medicine for asthma and severe chronic rhinosinusitis with nasal polyp

• MHRA approves tisotumab vedotin for the treatment of cervical cancer

• MHRA Mirdametinib approved to treat plexiform neurofibromas in children, adolescents, and adults with neurofibromatosis type 1

• EMA New medicine to treat non-muscle invasive bladder cancer

• MHRA approves lenacapavir for the prevention of sexually transmitted HIV-1 infection

RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough health technologies

Patients in the UK and Singapore could gain faster access to cutting-edge healthcare innovations under a new partnership bringing two globally respected regulators together with one of the world’s leading biotech creators. As part of this first-of-its-kind regulatory collaboration, the UK’s MHRA and Singapore’s Health Sciences Authority (HSA), with Flagship Pioneering as its first partner, companies will have a coordinated pathway enabling them to engage with both regulators at the same time. Under the new corridor, developers will be able to seek early, informal joint advice, helping them plan ahead and design better clinical trials, avoid duplication and cut delays.

Strengthening collaboration between the MHRA and the Department of Health Northern Ireland

As part of this growing partnership MHRA will:

• expand the use and visibility of the MHRA Yellow Card scheme across Northern Ireland

• continue to work together with Northern Ireland partners to ensure participation in cutting-edge research

• establish an MHRA presence in Northern Ireland

• explore opportunities for the development of regulatory science and innovation in Northern Ireland

This statement builds on commitments to collaborate that emerged from the first ever MHRA Board seminar held in Belfast in November 2025

Updated guidance on the Health Institution Exemption to support safe use of medical devices

This updated MHRA guidance will help health institutions, such as NHS Trusts and Boards, safely design and make general medical devices for patients. This will support hospitals and other health institutions to manufacture new devices, or modify existing devices, to meet specific clinical needs for their own patients – from specialist software that supports precise drug dosing to communication aids designed to help patients with a communication impairment.

The updated guidelines will provide health institutions clearer direction on when and how the Health Institution Exemption can be applied in practice.

The guidance also provides examples to clarify the types of organisations that may fall within scope, and those that do not.

MHRA seeks input on AI regulation at ‘pivotal moment’ for healthcare

A National Commission is seeking evidence to shape regulation of AI in healthcare and support the UK’s ambition for a world-leading, AI-enabled NHS

The call for evidence seeks to hear from everyone, whether they are familiar with how AI is being used in healthcare or simply have thoughts about what rules should be in place to ensure it is proportionately regulated.

Key themes include:

• Modernising the rules for AI in healthcare

• Keeping patients safe as AI evolves

• Clarifying responsibility

Europe

European Medicines Agency (EMA)

Minutes of the 129th meeting of the Management Board

Minutes of this meeting which was held virtually in Amsterdam on 2 October 2025 were adopted and subsequently published on 14 November.

[Well worth a skim through and a careful read of sections pertinent to you / your company, as a reminder of recent events and a heads up for coming ones. MBH]

EMA Management Board: highlights of December 2025 meeting

The Management Board welcomed the political agreement reached by the European Commission, the European Parliament and the Council of the European Union on the new EU pharmaceutical legislation.

The Board also adopted EMA’s work programme for 2026, as well as adopting the final programming document for 2026-2028 (to be published at the end of January 2026) and the preliminary programming document for 2027-2029.

Draft Guideline on quality of radiopharmaceuticals

This draft guideline describes the specific additional information that needs to be submitted in relation to the chemical, pharmaceutical and biological information for radiopharmaceuticals based on synthetic chemical substances, in the context of applications for marketing authorisations or variations to authorised medicinal products.

Radiopharmaceuticals are a special type of medicinal products. The particularities of radiopharmaceuticals derive mainly from the fact that, when ready for administration to the patient, they contain one or more radionuclides, that the strength is expressed in terms of the radioactivity (radioactivity concentration for liquid dosage forms or total radioactivity per dosage unit in some cases), the posology is expressed in terms of the amount of radioactivity administered to the patient and not in terms of mass (or amount of substance) and finally, that the amount of radioactivity decreases with time as a consequence of the radioactive decay.

The deadline for comments is 30 April 2026

Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals

Since the release of the current version of Annex 3, several revisions of GMP, ICH, other EMA radiopharmaceutical relevant guidelines and of the EU legislation have been adopted, introducing new concepts that are not considered in the current version.

In addition, the experience gained during GMP inspections of radiopharmaceuticals indicates that a revision of Annex 3 is necessary to avoid inconsistent interpretations and to clarify sections in the current version.

Furthermore, recent developments in the field of radiopharmaceuticals, e.g. analytical capabilities and radiosafety equipment, also need to be considered in the revision.

The EMA GMP/GDP Inspectors Working Group and the PIC/S Sub-committee on GMDP Harmonisation jointly recommend that the current version of Annex 3 is revised to reflect changes in regulatory and manufacturing environments, according to this concept paper.

EMA welcomes political agreement on new EU pharmaceutical legislation

The landmark political agreement was reached by the European Commission, the European Parliament and the Council of the European Union on the comprehensive reform of the EU pharmaceutical legislation.

This represents the most significant overhaul of the regulatory framework in over two decades and is a once-in-a-generation opportunity to reshape medicines regulation in the EU.

The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU.

Key elements include:

• A simpler regulatory environment

• More support and improved conditions for innovation

• Stronger safeguards against medicine shortages

• Enhanced environmental protection and focus on antimicrobial resistance

Guidance on GMP and GDP Q&A

A new Q&A has been added to the section 'EU GMP guide annexes: Supplementary requirements: Annex 16

Q&A for applicants, marketing authorisation holders of medicinal products and notified bodies regarding medicines used in combination with medical devices and consultation procedures for certain medical devices

This is revision 6 of this document. Readers may wish at least initially to see the Track Changes version of the document to more easily identify changes that are pertinent to their operations.

Guideline on the Development and Manufacture of Synthetic Peptides

This guideline addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic peptides which are not covered in the Guideline on the Chemistry of Active Substances or Chemistry of Active Substances for Veterinary Medicinal Products. It also contains requirements and considerations related to conjugation, to medicinal product development, to synthetic peptide development using biological peptides as European reference medicinal product, and to investigational medicinal products (human products only).

The purpose of this guideline is to set out the type of information required for the development, manufacture and control of synthetic peptides (existing or new chemical entities) used in a medicinal product.

Synthetic peptides are at the interface of small molecules and proteins and, from a quality point of view, specific considerations apply to this class of therapeutics.

The guideline is applicable to Marketing Authorisation Applications and post-authorisation procedures; specific considerations related to Investigational Medicinal Products are provided in section 7 of this guideline and applicants are advised to liaise with the relevant National Competent Authorities (NCAs)responsible for the approval and supervision of clinical trials.

The guideline is effective from 1 June 2026.

Shortage Prevention Plan (SPP) and Shortage Mitigation Plan (SMP) pilot report

Conclusions and next steps were:

The SPP and SMP pilot has proven to be a highly valuable exercise, offering important insights into the implementation process and highlighting key areas for improvement to support the effective implementation of the new pharmaceutical legislation. In particular, the voluntary feedback received and active participation of MAHs and NCAs enriched the pilot process and will help guide future steps to optimise SPP and SMP templates and guidance.

The SPP and SMP templates will require further review and update to address the findings of the pilot and to ensure the necessary information is captured to inform deployment of the vulnerability assessment methodology. In addition, the guidance will be updated in the first quarter of 2026 considering the findings and the outcome of the co-legislative process.

Industry reporting via the ESMP during a crisis or MSSG-led preparedness action.

The European Shortages Monitoring Platform (ESMP) supports management of medicine availability across the EU/EEA.

This fact sheet outlines the reporting obligations for MAHs in times of crises and during MSSG-led preparedness actions.

European Shortages Monitoring Platform (ESMP): Interoperability with national and pharmaceutical industry systems

ESMP enables easy and consistent data sharing across the systems of national competent authorities (NCAs) and marketing authorisation holders (MAHs) for monitoring and reporting medicine shortages in the European Union (EU).

The platform's interoperability with the systems from NCAs and MAHs ensures that data can be easily exchanged between these systems.

For NCAs and MAHs who already store their data within their internal systems, the platform enables data extraction and direct upload into it. They can still manually submit data through the ESMP interface.

Q&A for biological medicinal products

Document updated 9 December 2025

Sections added:

• Safety related critical in-process controls? (3.2.S.2, 3.2.P.3)

• Reference standard qualification protocols (3.2.S.5, 3.2.P.6)

• Date of manufacture (3.2.P.3.3 )

• Bioburden testing (3.2.P.3, 3.2.P.5 )

• Visible particles (3.2.P.5 )

• Protein content determination (3.2.P.5.1)

Sections updated:

• Monoclonal antibodies specification, ADCC activity (3.2.S.4.1, 3.2.P.5.1)

• Low Endotoxin Recovery, Endotoxin masking effect (3.2.P.5.3)

• Non-novel excipients with an intended biological effect and manufactured using recombinant technology (3.2.P.4, 3.2.A.3)

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

Certification monthly report of activities: End of October 2025

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

Ph. Eur. publication schedule evolves to better meet users’ needs

Together with its transition to a fully online version, the Ph. Eur. is adopting a new publication schedule that will extend the period between publication and implementation dates from six to nine months. This move will give users more time to prepare for upcoming modifications.

Issue 13.1 will be published on the Ph. Eur. platform in April 2026, with an implementation date of January 2027 for its new and revised texts.

183rd session of the European Pharmacopoeia Commission (EPC)

The EPC adopted 81 texts at this session, to be published in European Pharmacopoeia (Ph. Eur.) Issue 13.1 (April 2026) and be effective as of 1 January 2027.

These 81 texts included 7 new monographs and 2 new general chapters. The general chapters are:

• Uniformity of delivered dose of inhalation and nasal preparations (2.9.54),

• Size-exclusion chromatography for recombinant therapeutic monoclonal antibodies (2.5.43).

1st Ph. Eur. individual monoclonal antibody medicinal product monograph

Ph. Eur. has continued to build upon its work in the field of therapeutic monoclonal antibodies with the publication of its first monoclonal antibody (mAb) medicinal product monograph, for the IgG1-antibody based TNF-alpha antagonist, Golimumab injection (3187). The new monograph is included in European Pharmacopoeia (Ph. Eur.) Issue 12.2, released in October 2025.As the first individual medicinal product monograph covering a monoclonal antibody, Golimumab injection constitutes another milestone in the European Pharmacopoeia Commission’s commitment to developing public standards for this class of biotherapeutics. The new monograph will come into force on 1 April 2026.

Pharmacopoeial discussion group achievements

The Pharmacopoeial Discussion Group (PDG) held its annual meeting from September 30 to October 1, 2025 in Tokyo, Japan.The group welcomed the Korean Pharmacopoeia (KP) as a candidate participant.

EDQM reference standards monthly newsletter – November 2025

4 new European Pharmacopoeia reference standard and 12 replacement batches released in November 2025.

Guideline on requirements for revision/renewal of certificates of suitability to the Ph. Eur.monographs

EDQM has revised this Guideline to align it with the requirements of the applicable revised EU legislation,

The revised guideline also clarifies situations where revision of an existing CEP is not possible and a separate CEP application is required, and gives guidance on changes related to implementation of CEP 2.0 and on expectations concerning the introduction or modification of a risk assessment.

The consultation deadline is 16 January 2026

A major step towards animal-free testing for the test for bacterial endotoxins

Starting 1 January 2026, the rabbit pyrogen test (general chapter 2.6.8. Pyrogens) will disappear from Ph. Eur. texts, ending decades of reliance on animal-based methods.

This change reflects a clear commitment: protecting animal welfare while ensuring the highest standards of patient safety and scientific rigour. From that date onwards, pyrogen testing will rely on modern, animal-free, science-driven approaches.

Manufacturers will choose methods based on the specific risks of the substance or product containing non-endotoxin pyrogens, using advanced alternatives to animal testing such as the monocyte-activation test or the bacterial endotoxins test (BET). For the latter, the European Pharmacopoeia Commission (EPC) is proud to announce that recombinant Factor C (rFC) – a synthetic, validated, animal-free solution – will be fully integrated as of Issue 13.1 of the Ph. Eur. as one of the seven methods that can be used to test for bacterial endotoxins (general chapter 2.6.14). Users retain method choice guided by risk assessment and suitability under Pyrogenicity (5.1.13). This marks a significant milestone in reducing dependence on natural resources like the horseshoe crab.

United States of America

The US Food and Drug Administration (USFDA)

Q3E Guideline & supporting documentation for Extractables and Leachables

FDA is announcing the availability of a draft guidance for industry entitled “Q3E Guideline for Extractables and Leachables” and a draft supporting document entitled “Supporting Documentation: Class 3 Leachable Monographs.” The draft guidance and supporting document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

FDA deadline for comments is 30 Jan 2026.

Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products.

This guidance addresses questions that firms may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products licensed under section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)) and prescription biosimilar products, including interchangeable biosimilar products, licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k)). This guidance does not make any recommendations for nonprescription products.

This guidance discusses considerations for presenting data and information about reference products or biosimilar products in promotional communications to help ensure that they are accurate, truthful, and non-misleading.

The recommendations in this guidance apply regardless of the medium of the communication (e.g., paper, digital).

International

PIC/S

Concept Paper on the Revision of EU-PIC/S GMP Annex 3 (Radiopharmaceuticals)

The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 3 (Good Manufacturing Practice for Radiopharmaceuticals) of the Good Manufacturing Practice (GMP) Guide.

This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 3, Manufacture of Radiopharmaceuticals, 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 provide guidance within some areas that were not covered in the current version issued in 2008, clarify some sections, and support innovative pharmaceutical manufacturing and control approaches.

This concept paper is submitted to a joint EMA - PIC/S public consultation from 15 December 2025 until 15 February 2026 and can be downloaded on the PIC/S website as well as on the EMA website.

Comments should be submitted via the EU Survey tool in accordance with the PIC/S - EMA Harmonised Consultation Procedure.

Switzerland

Swissmedic

Medicinal products containing the active substance paclitaxel as paclitaxel albumin

Swissmedic is adapting its review practice for new applications for medicinal products containing the known active substance paclitaxel as paclitaxel albumin to the new EMA guideline

The EMA Guideline enters into force on 1 January 2026. Swissmedic is already following the principles it specifies and is taking these into account in the review of new applications.

Accordingly, in future, a clinical bioequivalence study can be waived for applications for new authorisation of medicinal products containing the known active substance paclitaxel albumin, provided that the analytical comparative data meet the scientific requirements in terms of quality and equivalence.

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 the first twice yearly biological medicine for asthma and severe chronic rhinosinusitis with nasal polyp

MHRA has approved depemokimab (Exdensur), the first twice-yearly biological medicine for use as an add-on treatment for asthma in adults and adolescents aged 12 years and older, and as an add-on treatment for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. Depemokimab has been approved, via the MHRA’s national assessment procedure,

The medicine is administered via injection under the skin once every six months.

The marketing authorisation was granted to GSK plc.

MHRA approves tisotumab vedotin for the treatment of cervical cancer

As of 2 December 2025 MHRA has approved tisotumab vedotin (Tivdak) used for the treatment of adults with cervical cancer that has come back or spread. It is used if the disease worsened after previous anti-cancer treatment.

Tisotumab vedotin is administered via an IV infusion into the vein over 30 minutes once every three weeks.

This approval provides a new treatment option for adults with cervical cancer.

The approval was granted on 2 December 2025 to GENMAB AS. This medicine has been approved through the International Recognition Procedure (IRP)

MHRA Mirdametinib approved to treat plexiform neurofibromas in children, adolescents, and adults with neurofibromatosis type 1

Mirdametinib (Ezmekly) is the first treatment for children as young as 2 years old with the genetic condition called neurofibromatosis type 1 (NF1).

NF1 is a rare genetic condition that can cause tumours to form on nerves throughout the body.

Mirdametinib works by blocking certain signals in the body that would otherwise allow these tumours to grow. It is available as a dispersible tablet, which can be swallowed whole or dissolved in water. Marketing authorisation approval was granted to SpringWorks Theraputics Ireland Limited.

At the time of approval, only one medicine was authorised in the UK for plexiform neurofibromas in patients aged three years and older. Mirdametinib provides an additional treatment option and has been shown to be effective in patients from a slightly younger age, starting at 2 years of age.

New medicine to treat non-muscle invasive bladder cancer

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Anktiva (nogapendekin alfa inbakicept) to treat adults with a type of bladder cancer that affects the lining of the bladder (non-muscle invasive bladder cancer, NMIBC) and that is at high risk of growing and spreading . Anktiva is used when the cancer does not respond to treatment with Bacillus Calmette-Guérin (BCG), a therapy that stimulates the immune system to help treat bladder cancer.

Anktiva is given as a solution directly into the bladder, together with BCG, once a week for 6 weeks, and then as maintenance therapy.

Anktiva is a type of immunotherapy that binds to a protein in the immune system known as the interleukin-15 (IL-15) receptor. This activates cells in the immune system that target and destroy cancer cells.EMA’s recommendation is based on the results of a single-arm clinical trial in 100 adults with BCG-unresponsive NMIBC who received Anktiva in combination with BCG given into the bladder weekly over 6 weeks.

Anktiva is recommended for a conditional marketing authorisation, one of the EU regulatory mechanisms to facilitate early access to medicines that fulfil an unmet medical need.

MHRA approves lenacapavir for the prevention of sexually transmitted HIV-1 infection

MHRA has approved lenacapavir (Yeytuo) for the prevention of sexually transmitted HIV-1 infection in adults and adolescents.

Lenacapavir works by reducing the risk of the HIV-1 virus multiplying and spreading throughout the body if a person is exposed to the virus.

Lenacapavir binds to the HIV-1 virus’s outer layer, interfering with the virus’ ability to multiply and spread.

Lenacapavir is administered via a combination of tablets and injections. It is given as an injection once every six months. For the first dose only, people also take two days of tablets by mouth. 

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

The approval was granted to Gilead Sciences LTD

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.