Review of Developments in GMP and the Regulation of Medicines September 2026
INTRODUCTION
The topics covered in this edition of the “Update” have come from the UK, EU, USA Swiss and Australian regulatory authorities.
Medicines and Healthcare Regulatory Authority (MHRA)
The Innovative Licensing and Access Pathway grants Innovation Passports to investigational products for cancer and dementia
Clinical trials: Phase 1, 14-Day Pilot Programme
MHRA position paper on regulation of microbiome-based medicinal products (MBMPs)
MHRA Safety Roundup: August 2026
European Medicines Agency (EMA)
Guidance for industry on implementing Shortage Prevention Plans (SPP)
EMA Shortage Prevention Plan Workshop Report
Regulators-Only Workshop on Reliance for Post-Approval Changes (PACs) | 18–19 May 2026
132nd meeting of the Management Board
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
Ph Eur turns its attention to phasing out the mouse LD50 assay from its monographs on botulinum toxin
New control of ethylene glycol and diethylene glycol in Macrogols (1444) published for comment
New Ph. Eur. reference standards available for implementation of the revised monograph on Erythropoietin concentrated solution
Certification monthly report of activities: End of July 2026
New general chapter on procoagulant activity testing of immunoglobulin preparations soon to be published in the Ph. Eur.
Update to the guidance for electronic submissions of CEP applications
Publication of a collaborative study on Ph. Eur. Heparin sodium BRP batches 5 and 6
Revised Guidance on applications for sister files.
Revised guidance about the use of a CEP to describe a material used in an application for another CEP
Ireland
Health Products Regulatory Authority (HPRA)
Delivery of Strategic Plan 2021–2025
Updated HPRA Guide to the Clinical Trials Regulation
The US Food and Drug Administration (USFDA)
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
Container Closure Systems for Human Drugs and Biological Products
Determining Whether to Submit an ANDA or a 505(b)(2) Application
Evaluation of Therapeutic Equivalence
Australia
Therapeutic Goods Administration(TGA)
Consultation on improving the sharing of information about medical devices
Swissmedic
Changes to the Q&A and guidance document on mobile technologies
MHRA approves remibrutinib for adults with chronic spontaneous urticaria
UK first in Europe to authorise orforglipron for weight management and type 2 diabetes
Vimseltinib (romvimza) approved for use in adults to treat tenosynovial giant cell tumours
Conferences
PHSS Airflow visualisation Airborne contamination control guidance
PHSS Annual Conference 2026: The Future of Pharmaceutical Manufacturing – Innovation, Readiness and Regulatory Confidence
PHSS QP Conference 2026
RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS
UK
UK
Medicines and Healthcare products Regulatory Agency (MHRA)
The Innovative Licensing and Access Pathway (ILAP) grants Innovation Passports (IP) to investigational products for cancer and dementia
Two Innovative investigational products recognised through the Innovative Licensing and Access Pathway ahead of next application round opening.
Following assessment by the ILAP Selection Panel, an IP has been awarded to:
· A biological medicine for hepatocellular carcinoma (liver cancer)
· A small-molecule medicine for dementia with Lewy bodies
These new IPs demonstrate the breadth of innovation that is supported through the ILAP and highlights the programme’s role in accelerating the development of potentially transformative medicines across a wide range of therapeutic areas.
Clinical trials: Phase 1, 14-Day Pilot Programme
The pilot is a targeted MHRA initiative to speed up approvals for certain low-risk Phase 1 trials. The pilot aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.
By piloting a two-week assessment timeline for suitable trials, the MHRA seeks to boost the UK’s competitiveness in early-phase research and encourage sponsors to run more Phase 1 studies in the UK.
MHRA position paper on regulation of microbiome-based medicinal products (MBMPs)
MHRA has published a position paper clarifying the UK licencing route for microbiome-based medicines, supporting developers to bring these innovative therapies to patients.
Microbiome-based medicinal products are medicines that work through modulating, restoring or replacing the human microbiome. They represent a promising new category of therapies with the potential to address areas of significant unmet clinical need such as antimicrobial resistance (AMR).
The MHRA’s position is that MBMPs fall within the scope of the existing UK medicines regulatory framework, set out in the Human Medicines Regulations 2012.
Depending on their characteristics, MBMPs may be regulated as biological medicinal products, or in some cases may meet the criteria for advanced therapy medicinal products (ATMPs).
No MBMP currently holds a UK marketing authorisation.
MHRA Safety Roundup: August 2026
This report provides a summary of the latest safety advice for medicines and medical device users.
Europe
European Medicines Agency (EMA)
Guidance for industry on implementing Shortage Prevention Plans (SPP)
The new pharmaceutical Regulation includes provisions aiming to reinforce medicines shortage monitoring and management and strengthen supply chain resilience in the Union, including the obligation for Marketing Authorisation Holders (MAHs) to put in place, and keep up to date, a shortage prevention plan (SPP) for any medicinal product subject to prescription in the EU. The scope may be further extended at the discretion of the European Commission.
In addition to the legal obligation, the recommendation for MAHs to have SPPs in place is included as one of the recommendations (recommendation 4) of the good practices for industry for the prevention of human medicinal product shortages.
The implementation of SPPs will facilitate the MAHs compliance of their obligation to ensure, within the limits of their responsibilities, an adequate and continuous supply to the market (Article 56(3), new pharmaceutical Directive).
This guidance indicates the relevant type and detail of information for shortage prevention plans, according to the different level of risk, including descriptions of the relevant shortage management measures. The degree of effort, formalisation and documentation for each SPP and consequent proposal of shortage mitigating measures should be proportionate to the identified level of risk for each medicine.
EMA Shortage Prevention Plan Workshop Report
On 22 June 2026, EMA organised a workshop to gather technical feedback from industry stakeholders on the updated Shortage Prevention Plan (SPP) template and guidance, which are being revised to align with the requirements of the forthcoming EU pharmaceutical Regulation. SPPs are intended to support the proactive identification, assessment, and mitigation of supply chain risks that could lead to medicine shortages.
The workshop demonstrated broad support for the objectives of the SPP framework while identifying areas requiring further refinement, including risk classification, flexibility for different product types, reporting burden and implementation guidance.
Regulators-Only Workshop on Reliance for Post-Approval Changes (PACs) | 18–19 May 2026
This workshop focused on moving reliance for post-approval changes (PACs) from pilots to routine practice. It combined evidence from EMA-WHO PAC reliance pilots with practical implementation experience from Serbia (ALIMS), Egypt (EDA) and South Africa (SAHPRA), framed by WHO Good Reliance Practices.
PACs are becoming more frequent and complex, while divergent requirements and long, unpredictable timelines increase workload, delay implementation, and raise shortage risks.
Emer Cooke, Executive Director of EMA, noted, “the question is no longer whether reliance is needed, but how to implement it in a way that improves efficiency, convergence, and predictability in practice”.
132nd meeting of the Management Board The minutes (19 pages) of this meeting, held in Amsterdam on 10-11 June 2026 have now been published.
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
Ph Eur turns its attention to phasing out the mouse LD50 assay from its monographs on botulinum toxin
At its June 2026 session, the European Pharmacopoeia Commission decided to reactivate the Botulinum Toxin Working Party (BOT WP), marking an important step towards the gradual phasing out of the mouse lethal dose 50% (mLD50) assay from the current European Pharmacopoeia (Ph. Eur.) monographs on Botulinum toxin type A for injection (2113) and Botulinum toxin type B for injection (2581).
This decision reflects the strong commitment and support to do so expressed by European regulatory authorities and manufacturers.
New control of ethylene glycol and diethylene glycol in Macrogols (1444) published for comment
Recent incidents involving contaminated or deliberately adulterated materials have highlighted the need for robust analytical procedures for the detection and control of ethylene glycol (EG) and diethylene glycol (DEG) in pharmaceutical excipients. These toxic contaminants remain a focus of attention for regulatory authorities and pharmacopoeias worldwide due to the risks they pose to patient safety.
As part of the Ph.Eur ongoing efforts to strengthen safeguards against EG and DEG contamination and adulteration of pharmaceutical products and to make detection of these impurities more robust, a new analytical procedure for their determination has been introduced in the Ph. Eur. Monograph Macrogols (1444) which covers 12 grades of macrogol, a substance also known as polyethylene glycol. The revised monograph has been published in Pharmeuropa 38.3 for public consultation.
The proposed text introduces a new gas chromatography (GC) procedure employing a capillary column, making it possible to quantify the impurities via a derivatisation step and the use of an internal standard. It also proposes revised limits for EG and DEG. While the current monograph describes a combined limit for ethylene glycol and diethylene glycol, the proposed text establishes individual limits for each contaminant: 620 ppm for ethylene glycol and 0.10 per cent for diethylene glycol. Both substances are also well-known process impurities especially in low-molecular mass grades of macrogols.
The new procedure included in this draft revised text follows other Ph. Eur. initiatives aimed at expanding the control of EG and DEG in pharmaceutical excipients, such as the recently adopted Propylene glycol (0430) and Glycerol (0496) monographs, or the ongoing activities on dedicated EG/DEG tests that will soon be proposed for liquid sorbitol and maltitol.
Interested parties are encouraged to review the draft text and submit comments, together with any relevant analytical data generated using the proposed GC procedure or another procedure, during the consultation period (deadline: 30 September 2026).
New Ph. Eur. reference standards available for implementation of the revised monograph on Erythropoietin concentrated solution
In response to the high demand for the current Erythropoietin for physicochemical tests CRS (catalogue reference Y0001725), a collaborative study was conducted to establish two new CRSs for erythropoietin, namely Erythropoietin for glycan analysis, peptide mapping and SDS-PAGE/immunoblotting CRS (catalogue reference Y0002611) and Erythropoietin for CZE CRS (catalogue reference Y0002610). The latter is intended solely for use as a reference standard in capillary zone electrophoresis (CZE, identification test B).
Certification monthly report of activities: End of July 2026
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
New general chapter on procoagulant activity testing of immunoglobulin preparations soon to be published in the Ph. Eur.
EDQM has continued to build upon its work in the field of plasma-derived medicinal products with publication of a new general chapter 2.6.42. Test for procoagulant activity in immunoglobulin preparations in the European Pharmacopoeia (Ph. Eur.). The chapter is accompanied by the revised monographs Human normal immunoglobulin for intravenous administration (0918) and Human normal immunoglobulin for subcutaneous administration (2788), which reference the new general chapter. All three texts are included in Ph. Eur. Issue 13.3, which will be published in October 2026.
Procoagulant activity (PCA) in immunoglobulin preparations, typically caused by activated human coagulation factor XI (FXIa), poses a potential safety concern. The new general chapter describes three methods for the detection of procoagulant activity in these preparations: a chromogenic substrate assay (CSA) specific to FXIa, and two methods – the thrombin generation assay (TGA) and the non-activated partial thromboplastin time (NAPTT) assay – which can also detect other potential procoagulant impurities. It provides guidance on how these methods can be implemented, including overcoming matrix effects and the use of appropriate controls, as well as recommendations for selecting an appropriate substrate plasma.
Update to the guidance for electronic submissions of CEP applications
EDQM has updated the guidance in order to reflect current requirements regarding the need to provide an eCTD validation report, as communicated previously. CEP applicants are encouraged to consult the updated guidance to ensure compliance with these revised requirements when preparing their CEP submissions.
The updated guidance:
· describes how the eCTD validation report should be named, where in the CEP application package it should be located, and the format in which it should be presented;
· indicates that changes to the content of module 3 of a CEP application should be described in module 1 and not highlighted in module 3 itself.
Publication of a collaborative study on Ph. Eur. Heparin sodium BRP batches 5 and 6
The outcome of the study to establish batches 5 and 6 of the European Pharmacopoeia (Ph. Eur.) Heparin sodium Biological Reference Preparation (BRP) has been published in Pharmeuropa Bio Scientific Notes – an online journal of the EDQM
Revised Guidance on applications for sister files.
The revised guidance aims to ensure a consistent understanding and implementation of this procedure by clarifying eligibility criteria, supporting the correct classification and assessment of Certificate of Suitability (CEP) applications and promoting transparency and equal treatment of applicants.
The updated guidance includes several important clarifications and improvements. In addition, the revised guidance provides an extended range of examples illustrating situations that may be considered acceptable under the sister file procedure. The EDQM’s expectations regarding the documentation to be submitted in support of a sister file application have also been clarified.
The revised guidance will enter into force on 1 September 2026.
Revised guidance about the use of a CEP to describe a material used in an application for another CEP
The revised document has been updated to reflect the implementation of CEP 2.0 and to align its content with the principles described in the EMA Quality Working Party (QWP) Q&A document on how to use a CEP in a Marketing Authorisation Application or a Marketing Authorisation Variation
CEP applicants and holders should refer to the updated document when preparing or revising CEP applications.
Ireland
Health Products Regulatory Authority (HPRA)
Delivery of Strategic Plan 2021–2025
The HPRA has now published the final progress update on delivery of the strategy. It summarises the principal achievements, areas of impact and organisational developments delivered over the lifetime of the plan, and provides an overall assessment of progress across each of the strategic goals and objectives.
Updated HPRA Guide to the Clinical Trials Regulation
The HPRA has published an updated guidance document for sponsors conducting clinical trials in Ireland. The guide has been updated to reflect the full implementation of the Clinical Trials Regulation (CTR), and to align with current European and national guidance and best practices. It outlines HPRA supports for sponsors, including regulatory advice to determine if a study falls within the scope of the CTR, and the option for pre-submission meetings for non-commercial sponsors.
United States of America
The US Food and Drug Administration (USFDA)
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
This draft guidance is intended to help applicants develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. This draft guidance expands on and clarifies the Agency’s recommendations and expectations regarding the development of delivery devices and container closure systems described in Q.I.4 of the guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and the guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product” for biosimilar and interchangeable biosimilar products, respectively.
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs
This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The guidance replaces the draft guidance (Revision 2) issued on April 13, 2023.
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA’s recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization studies. This draft guidance replaces the previous draft guidance of April 2023.
Container Closure Systems for Human Drugs and Biological Products
This draft guidance document provides guiding principles for evaluating the quality of container closure systems (CCSs) used to package drugs and biological products, for human use. This includes CCSs that are also device constituent parts of combination products and CCSs used to package the drug or biological product constituent parts of combination products.
Specifically, this guidance discusses FDA’s current thinking on how to evaluate CCSs according to a risk-based framework that includes quality assessments and quality control of packaging materials and components.
When final, this guidance will supersede the guidances for industry Container Closure Systems for Packaging Human Drugs And Biologics (May 1999) and Container Closure Systems for Packaging Human Drugs and Biologics — Questions and Answers (May 2002).
FDA intends to supplement this guidance with additional guidances to provide topic-specific recommendations related to the general information described in this guidance. These topic-specific guidances will address methods related to evaluating and characterizing novel CCSs and provide information about specific quality attributes and testing requirements, including considerations for extractables and leachables evaluations and associated toxicological risk assessments.
Determining Whether to Submit an ANDA or a 505(b)(2) Application
This draft guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA. This draft guidance revises the guidance for industry issued in May 2019 and, when finalized, will replace the 2019 guidance for industry.
Evaluation of Therapeutic Equivalence
This guidance explains FDA’s thinking on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes). FDA’s therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the FD&C Act in the active section of the Orange Book.
This guidance finalizes the draft guidance of the same title issued in July 2022.
International
Australia
Therapeutic Goods Administration (TGA)
Consultation on improving the sharing of information about medical devices
The proposed changes intend to provide more information to the public after post-market reviews or investigations of medical devices, particularly where review findings relate to the safety, quality, performance or use of a medical device.
These proposed changes align with the intent of ‘An action Plan for Medical Devices’, which aims to provide more information to patients about the medical devices they use.
TGA are seeking feedback on proposals to expand its ability to release information lawfully under section 61 of the Therapeutic Goods Act 1989. We would like to know if:
· We should share information about medical devices included in a post-market review or investigation, and
· What types of information should be shared when a post-market review or investigation is being undertaken.
Consultation period ends 2 Oct 2026
Switzerland
Swissmedic
Changes to the Q&A and guidance document on mobile technologies
There have been an increasing number of queries on implementing the requirements with regard to the details and placement of Uniform Resource Locator (URLs0, the placement of QR codes and captions for QR codes. Swissmedic has therefore revised the guidance document. The aim of the changes is to clarify which elements are mandatory and which are recommended. It has been made clear that aspects such as the use of a URL and labelling of QR codes with a caption such as “Medicinal product information” are presented as recommendations.
The revised guidance document is valid with effect from 1 August 2026. The two new Q&A’s on mobile technologies are also be available on Swissmedic’s website.
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 remibrutinib for adults with chronic spontaneous urticaria
MHRA has approved remibrutinib (Rhapsido) 25 mg film-coated tablets for the treatment of adults with chronic spontaneous urticaria (CSU) whose symptoms are not adequately controlled by antihistamines.
Chronic spontaneous urticaria is a long-term condition that causes recurrent hives, itching and swelling.
In people with CSU, the immune system can become overactive. Remibrutinib works by blocking Bruton’s tyrosine kinase (BTK), helping to reduce inflammation and make symptoms less frequent and less severe.
This marketing authorisation was granted to Novartis Pharmaceuticals UK Limited and was submitted and approved via the International Recognition Procedure (IRP) Route B.
UK first in Europe to authorise orforglipron for weight management and type 2 diabetes
This GLP-1 tablet alongside a reduced-calorie diet and increased physical activity, is authorised for weight loss and weight maintenance in adults in the UK with a BMI of 30 or above, or a BMI of between 27 and 30, and at least one weight-related comorbidity. It is also authorised to improve glycaemic control for patients with insufficiently controlled type 2 diabetes.
Authorisation for this new indication for orforglipron (Foundayo) was granted to Eli Lilly.
Vimseltinib (romvimza) approved for use in adults to treat tenosynovial giant cell tumours
MHRA has approved vimseltinib (romvimza) to treat adult patients with tenosynovial giant cell tumour (TGCT) when it impacts movement or where surgery is not an option. TGCT is a rare non-cancerous tumour that forms around a joint and tendons.
The active ingredient in Romvizma, vimseltinib, helps slow the growth of TGCTs by blocking the proteins that cause these tumours to grow.
Vimseltinib is a capsule that should be swallowed whole with water and with or without food, twice a week.
The new marketing authorisation was granted to Deciphera Pharmaceuticals. This product was submitted and approved via the International Recognition Procedure (IRP) Route B.
Conferences / webinars / workshops etc.
PHSS Airflow visualisation Airborne contamination control guidance
The successful PHSS Airflow visualisation online training applied in Airborne contamination control is to be updated and presented over two new dates, covering attendees from different time zones. The online training builds on PHSS research into characterisation of Protective Airflows, including First Air protection for compliance to EU GMP & PICS Annex 1.
These trainings will follow publication of PHSS guidance documents:
1) Definitions of Airflows in GMP applications
2) Protective Airflow and First Air protection.
PHSS Annual Conference 2026: The Future of Pharmaceutical Manufacturing – Innovation, Readiness and Regulatory Confidence
The conference will provide a valuable forum for knowledge sharing, professional networking and discussion of the key topics shaping the future of pharmaceutical manufacturing. We are especially fortunate to be hosted by Moderna for both the site tour and the conference, giving delegates the chance to experience the Harwell facility and gain insight into the environment supporting innovation, operational readiness and advanced manufacturing capability.
PHSS QP Conference 2026
PHSS QP Forum Conference is an annual event for Qualified Persons and pharmaceutical professionals, with a programme focused on complex supply chains, herbal medicines, new GMP/ICH guidance, decentralised manufacturing, and clinical trials for ATMPs.
The agenda also includes time for networking, discussion, and QP-relevant updates across the day.
Designed for Qualified Persons – and the professionals who support them.
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.
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