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

EJPPS Volume 31.2A

The topics covered in this edition of the “Update” have come from the UK, EU, USA Swiss and Australian regulatory authorities.

UK 

Medicines and Healthcare products Regulatory Agency (MHRA)

·       Joint Statement from the UK Space Agency, the Medicines and Healthcare products Regulatory Agency, the Regulatory Innovation Office and the Civil Aviation Authority

·       Man jailed for ten years for convictions including selling prescription-only medicines worth more than £3.7 million

·       The £1.4bn opportunity: How reclassification can transform healthcare, improve access to medicines and enable growth

·       Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process

·       Precautionary recall of Hibiwash

·       MHRA action boosts drive to phase out animal testing

·       Clinical trials for medicines: GMP and radiopharmaceutical investigational medicinal products

EU

European Medicines Agency (EMA)

·       Concept paper on the development of a reflection paper on the non-clinical development and evaluation of microbiome-based medicinal products

·       Quality of medicines: Q7A - Part 1

·       Methodology to Identify Vulnerabilities in Supply Chains of Critical Medicines

·       EMA Management Board: highlights of March 2026 meeting

·       Pharmaceutical quality system (PQS) effectiveness pilot project

·       Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products

·       Guidance on GMP & GDP Q&A.

·       EMA consults on virtual control groups to help reduce animal use in medicines development

The European Directorate for the Quality of Medicines & HealthCare

·       Reference standards monthly newsletter – February 2026

·       Middle East supply chain disruptions

·       Certification monthly report of activities: End of February 2026

·       Joint EDQM-EPAA Symposium Pyrogen testing 2.0

·       European anti-D plasma collection programmes – Key technical report published by the CD-P-TS 

·       New milestone in the development of the certification concept for rapid microbiological methods

·       Outcome of the 184th session of the European Pharmacopoeia Commission

·       New EDQM guidance on reliance-based or fast-track assessment of CEP applications 

Ireland

Health Products Regulatory Authority (HPRA)

·       Mandatory Use of EUDAMED modules for medical devices

·       Over 750,000 units of illegal medicines detained by the HPRA in 2025

USA

The US Food and Drug Administration (USFDA)

·       New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products:Q&A

·       Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Draft Guidance for Industry – for comment.

·       Q&A on Biosimilar Development and the BPCI Act

·       Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs    

International

Australia

Therapeutic Goods Administration (TGA)

·       Improving the regulation of sunscreens in Australia

Switzerland

Swissmedic

·       Revision of chapters 20 and 21 of the Pharmacopoea Helvetica 13

Products

·       MHRA approves deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults

Conferences

·       The PHSS Virtual Aseptic Processing Workshop 2026 

·       Protective Airflow including First Air Visualisation Virtual Training

RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

Joint Statement from the UK Space Agency, the Medicines and Healthcare products Regulatory Agency, the Regulatory Innovation Office and the Civil Aviation Authority

UK Space Agency, MHRA, RIO and CAA set out support for in-orbit manufacturing of pharmaceuticals, The UK is committed to advancing its leadership in space-enabled manufacturing. In-Orbit Manufacturing (IOM) is one subset of the wider In-Orbit Servicing, Assembly, and Manufacturing (ISAM) market. It represents a transformative opportunity to produce materials and products in space that offer superior quality and performance compared to those manufactured on Earth. The UK Space Agency is providing funding for three in-orbit manufacturing feasibility studies including a £250,000 feasibility study for BioOrbit, a pioneering start-up that is designing a scalable in-orbit manufacturing system to crystallise biologic drugs for cancer treatments. In-orbit manufacturing of pharmaceuticals offers transformative potential across multiple domains, from precision medicines for oncology and rare diseases to drug stability for remote and crisis-affected populations. This reinforces the UK’s commitment to enabling innovation in pharmaceutical manufacturing. This includes supporting the development of novel modalities that could enhance drug quality, improve supply chain resilience and unlock new therapeutic possibilities for patients.

[Well, this is something different!! MBH]

Man jailed for ten years for convictions including selling prescription-only medicines worth more than £3.7million

Having pleaded guilty to five offences at an earlier hearing, Mark Robert Witchell, aged 61, of Stoke-on-Trent, was sentenced on 3 March 2026 at Stoke-on-Trent Crown Court. Three others were convicted and sentenced in March 2023 with similar offences.

Witchell was arrested upon attempting to re-enter the United Kingdom via ferry following a 10-year period overseas in Brazil. For the first time in the MHRA’s history, the CEU took the rare step of seeking extradition and work was ongoing to extradite him to the UK, at the time of Witchell’s return.

The £1.4bn opportunity: How reclassification can transform healthcare, improve access to medicines and enable growth

Empowering people to take control of their own health is an essential pillar of a sustainable healthcare system. As pressure on primary care grows, we must seize every opportunity that enables individuals to manage minor conditions safely and confidently, reducing unnecessary GP appointments and ensuring time is focused on those who need it most. Reclassification of medicines is a practical and impactful way to deliver this shift, broadening access to trusted treatments and giving people faster, more convenient routes to care.

In the latest of MHRA’s strategy blogs, PAGB CEO, Michelle Riddalls explores the scale of this opportunity — for the public, the NHS, and a consumer healthcare sector ready to drive innovation. By strengthening the role of pharmacists and supporting a more prevention‑focused model, reclassification doesn’t just expand choice, it helps build a healthier, more resilient system for everyone. When people are equipped with the right tools, information and access, the benefits ripple across the entire health landscape.

Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process

Patients in England are set to receive some new medicines three to six months earlier under a streamlined approval process being launched by the MHRA)and National Institute for Health and Care Excellence (NICE).The aligned pathway, which launches on 1 April, will help to bring NICE’s decision-making process forward to run alongside MHRA’s, resulting in decisions on licencing and value being made at the same time.

Alongside the pathway, NICE and the MHRA are also launching an improved Integrated Scientific Advice service. This will offer a single-entry point, meeting and report, and one payment, while aligning data and scientific expectations where possible.

Precautionary recall of Hibiwash

As a precautionary measure, Mölnlycke Health Care is recalling three batches of Hibiwash, an antimicrobial wash, due to microbial contamination at the manufacturing facility.

Contamination with Burkholderia cepacia was identified during routine weekly monitoring but there have been no reports of patient harm.  

The risk from Burkholderia cepacia is very low for most people, but some patient groups are at a higher risk and may be more vulnerable to infection. This includes patients who have cystic fibrosis or are awaiting lung transplant. There have currently been no confirmed cases of Burkholderia cepacia infection in patients from the affected batches.

[Over the years this organism has cropped up fairly often and continues to do so (despite its name change). Interestingly this issue was picked up during routine monitoring – a good reminder as to how important such monitoring and indeed contamination control strategies are in our operations MBH]

MHRA action boosts drive to phase out animal testing

By offering early review of non‑animal data and clarifying how it will be assessed, the UK’s medicines regulator aims to give developers more confidence when making marketing applications based on evidence generated without animal testing.

Clinical trials for medicines: GMP and radiopharmaceutical investigational medicinal products

This guidance on GMP and the use of radiopharmaceutical investigational medicinal products in clinical trials.

These amendments come into force on 28 April 2026.

This guidance is also relevant to the manufacturing sites that are named in clinical trial application submissions, and involved in the processing of investigational medicinal products.

Europe

European Medicines Agency (EMA)

Concept paper on the development of a reflection paper on the non-clinical development and evaluation of microbiome-based medicinal products (MMPs)

Unlike standard pharmaceuticals, MMPs may consist of live or non-living microorganisms or their derivatives. These products can modulate the human microbiome through diverse mechanisms, which vary depending on the strain of microorganism and the site of administration. This complexity introduces unique challenges for non-clinical evaluation. The EMA recognizes the growing interest and rapid development in this field and acknowledges the need for regulatory guidance to ensure a harmonized approach to non-clinical development and evaluation.

The objective of this concept paper is to identify aspects specific to MMPs that need to be addressed in a dedicated reflection paper. This reflection paper will outline the current thinking on the non-clinical evaluation of MMPs and support a harmonized approach across the European Union for clinical trials and marketing authorisation applications, as per Directive 2001/83 on medicinal products.

Quality of medicines: Q &A - Part 1

Several sections of this Q&A were amended in January 2026. The concerned sections are clearly identified by date in the Q&A

Methodology to Identify Vulnerabilities in Supply Chains of Critical Medicines

This document outlines the methodology and governance that has been developed in the Working Group of the MSSG on the vulnerability assessment methodology to identify vulnerabilities in the supply chains of medicines on the Union list of critical medicines (ULCM), as set out in new pharmaceutical legislation and considering associated provisions included in the Critical Medicines Act.

This methodology was adopted by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on 17 November 2025. The Working Group was tasked with developing a practical and implementable methodology in a 6-month timeline.

An alternative approach to prioritisation of the first set of INNs was agreed at MSSG on 30 January, to enable completion of initial assessments before the end of 2026.

EMA Management Board: highlights of March 2026 meeting

The Management Board adopted EMA’s annual report for 2025, marking another strong year for medicines regulation in the European Union. EMA delivered 104 positive recommendations for new medicines for human use, including 38 containing a new active substance. The Agency also issued 30 recommendations for new veterinary medicines - the highest number of recommendations for a second consecutive year.

The report, including an interactive digital version, will be published in May 2026.

Highlights include:

·       Preparations for implementation of the new EU pharmaceutical legislation

·       Electronic product information implementation roadmap

·       EMA reports on stakeholder engagement activities 2024-2025

·       Monitoring EMA’s independence policies

·       Impact of war in the Middle East

·       Executive Director vacancy notice

·       Clinical trials in the EU

Pharmaceutical quality system (PQS) effectiveness pilot project

The GMP / Good Distribution Practice (GDP) Inspectors Working Group is running a pilot to assess how the effectiveness of a site’s pharmaceutical quality system (PQS) for risk‑based change management can be demonstrated, and whether the EEA GMP certificate could serve as the main evidence of this effectiveness.

Demonstrating robust PQS effectiveness is a key requirement for using the additional regulatory tools introduced under the revised variations framework, which became applicable in the EU in January 2026. This includes tools such as the product lifecycle management (PLM) document.

Marketing authorisation holders and manufacturers can nominate their sites to undergo on‑site PQS) effectiveness assessments by European Economic Area (EEA) GMP inspectors

Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products

Revision 2 of this document has now been published.

Guidance on GMP & GDP Q&A.

An update log is now available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in March 2026 when 'Implementation of 3DP technology (Additive Manufacturing Technology) for solid oral dosage forms' section was added.

EMA consults on virtual control groups to help reduce animal use in medicines development

EMA’s human medicines committee (CHMP) has issued a draft qualification opinion for a new methodology in preclinical research, which can reduce the overall number of animals (rats) used in specific dose-range finding studies. This method replaces standard (concurrent) animal control groups with virtual control groups. By qualifying this new approach methodology (NAM), the CHMP can accept evidence generated using virtual control groups (within the defined context of use) as scientifically valid in future medicines applications.

Through the integration of virtual control groups, EMA also seeks to improve the relevance and predictability of non-clinical testing, which supports both more efficient and more ethically responsible medicines development.

A key requirement for the implementation of virtual control groups is the assurance that their use does not compromise study outcomes or pose a threat to human safety in later clinical trials.

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

EDQM reference standards monthly newsletter – February 2026

Reference standards monthly newsletter – February 2026

3 new European Pharmacopoeia reference standards and 10 replacement batches released in February 2026.

Middle East supply chain disruptions

Due to the ongoing conflict in the Middle East, several airspaces and routes are currently closed, causing significant disruption to air freight. Airlines have suspended flights and implemented temporary embargoes.

Airspaces closed until 8 March 2026: Israel, Lebanon, Jordan, Iraq, Qatar, Kuwait, Bahrain, the Dammam area (Saudi Arabia), Iran and the United Arab Emirates.

EDQM will continue processing your orders in its system. However, dispatches to or transiting the affected areas are on hold until reliable logistical solutions are available.

Certification monthly report of activities: End of February 2026

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

Joint EDQM-EPAA Symposium Pyrogen testing 2.0

A joint symposium was held on 25 and 26 February 2026 in Brussels, Belgium, co-organised by the EDQM and the European Partnership for Alternative Approaches to Animal Testing (EPAA). The event was attended by over 800 participants (including 100 on-site) from 71 countries. The level of engagement, dynamic exchanges and broad consensus across stakeholders showed how a once strictly European initiative has now been globally embraced, making the symposium impactful and underscoring the shared commitment to advancing the global transition to animal‑free pyrogenicity testing.

European anti-D plasma collection programmes – Key technical report published by the CD-P-TS 

The report addresses the need to (re-)establish anti-D plasma collection programmes within Europe. Anti-D immunoglobulin (IgG) remains essential for preventing haemolytic disease of the foetus and newborn (HDFN) and is the only effective prophylactic treatment for pregnant women at risk of RhD alloimmunisation in Europe. However, almost all anti-D IgG used in Europe is sourced from plasma collected in the United States – a structural vulnerability highlighted by the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA).

Drawing on survey findings, international expert consultations and case studies from Europe, Australia and the United States, the CD-P-TS report outlines technical, regulatory and operational pathways for building sustainable anti-D plasma collection capabilities at national and pan-European levels. The report identifies several key priorities.

New milestone in the development of the certification concept for rapid microbiological methods

At its 184th Session in March 2026, the European Pharmacopoeia Commission (EPC) approved the creation of a new working party dedicated to the technical development of the certified review of microbiological methods per the European Pharmacopoeia, a novel concept that will also be known as “cMEP”.The cMEP is based on a method‑centric approach intended to facilitate the use of rapid microbiological methods (RMMs) by providing a harmonised scientific review of their validation and comparability, in accordance with the European Pharmacopoeia.

Outcome of the 184th session of the European Pharmacopoeia Commission

The European Pharmacopoeia Commission (EPC) adopted 50 European Pharmacopoeia (Ph. Eur.) texts that will be published in Issue 13.2 (July 2026) and will be effective as of 1 April 2027, and approved four new texts for the European Drug Shortages Formulary (EDSForm) and European Paediatric Formulary (PaedForm).

The Ph. Eur. texts included five new monographs and two new general chapters, the remaining 43 texts were revisions,

New EDQM guidance on reliance-based or fast-track assessment of CEP applications EDQM has published two new guidelines describing how CEP holders or prospective applicants can request reliance-based or fast-track assessment of their dossiers.

The first guideline details when and how prospective CEP applicants may benefit from expedited and harmonised assessment of their CEP application based on prior regulatory approval within the European Union, EEA, Switzerland, the UK, Australia, Canada or the WHO pre-qualification programme.

The second guideline provides information on how regulatory authorities, as well as prospective CEP applicants and holders, can request fast-track assessment of dossiers to address recognised shortages in Europe and/or where fast-track assessment aligns with the objectives of the EU Critical Medicines Act.

Ireland

Health Products Regulatory Authority (HPRA)

Mandatory Use of EUDAMED modules for medical devices

Mandatory use of four EUDAMED modules for medical devices begins on 28 May 2026.

This follows the Commission's publication of the functionalities of the four  EUDAMED modules in the Official Journal of the European Union in November 2025.

Over 750,000 units of illegal medicines detained by the HPRA in 2025

Over three quarters of a million dosage units of falsified and illegal medicines were detained by the HPRA in 2025.

Announcing its annual enforcement figures, the HPRA confirms that it detained a total of 763,027 dosage units which included just under 14,000 individual packages each linked to a separate purchase by a member of the public of illegal or falsified medicines. This represents a threefold (180%) increase of individual consignments since 2024. A significant proportion of these were presented as GLP‑1 products for personal use. In the 12 months of 2025, the most significant categories of illegal products detained included sedatives (27%), erectile dysfunction medicines (14%), anabolic steroids (12%), diabetes/slimming (9%) and analgesics (5%).  The HPRA,

·       Initiated a prosecution relating to the manufacture and distribution of GLP-1 medicines;

·       Shutdown or amended 4,762^ websites, e-commerce listings and/or social media pages.

United States of America

The US Food and Drug Administration (USFDA)

New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products:Q&A

This guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or NDA supplement. The guidance discusses the statutory and regulatory criteria for eligibility for New Clinical Investigation exclusivity and provides recommendations on the content and format of requests for New Clinical Investigation exclusivity in the form of questions and answers (Q&As).

FDA intends to update this draft guidance document to include additional Q&As as appropriate

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Draft Guidance for Industry – for comment.

Although establishments are not required to respond to FDA’s observations listed in an FDA 483, FDA recommends that those establishments that choose to respond submit their responses within 15 business after the FDA 483 was issued. Generally, if FDA receives a response to an FDA 483 within 15 business days after the FDA 483 was issued, FDA plans to conduct a detailed review of the response before determining whether to pursue subsequent action. FDA recommends establishments address all observations within this 15-day time period by submitting a single response to an FDA 483, rather than multiple responses to individual observations. In the case of complex observations that are not fully addressed within 15 business days, FDA recommends establishments submit a CAPA plan and a proposed time frame for substantive responses to the observations within 15 business days. FDA will not ordinarily delay regulatory action, such as issuing a warning letter, to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued.

Q&A on Biosimilar Development and the BPCI Act

At this time, FDA is withdrawing Q&As I.8, I.10, and I.19 from the final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act” issued September 20, 2021, and reissuing the final guidance (with certain updates to the introductory text) solely for the purpose of withdrawing these particular Q&As. The Agency continues to evaluate other Q&As in this final guidance as part of its efforts to further enhance efficiency in biosimilar development programs and intends to update any Q&As that may no longer reflect the Agency’s current thinking, as appropriate.

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs

This guidance provides recommendations for physicochemical and structural (collectively, Q3) characterizations that can be used (1) to identify the dosage form of a proposed generic (test) topical product and (2) to describe properties of the drug product that may be critical to its performance (to support a demonstration of bioequivalence (BE). When comparing the Q3 attributes of two topical products (e.g., to support a demonstration of BE), we generally advise that applicants conduct a comparative Q3 characterization of their proposed generic product against the reference standard, which ordinarily is the reference listed drug (RLD).

International

Australia

Therapeutic Goods Administration (TGA)

Improving the regulation of sunscreens in Australia

TGA has opened an 8-week public consultation, ‘and is inviting interested parties to provide a response by 23 May 2026.

Given Australia has the highest rates of skin cancer and melanoma in the world, with around 2,000 people dying each year, it is critical that the regulatory settings are appropriate to ensure consumer confidence in sunscreens.

Switzerland

Swissmedic

Revision of chapters 20 and 21 of the Pharmacopoea Helvetica 13

To clarify the distinction under therapeutic products legislation between manufacture and preparation for administration, Swissmedic decided, with effect from 1 June 2025, to make an urgent amendment to the Good Manufacturing Practice rules for medicinal products in small quantities as stated in the Swiss Pharmacopoeia (Ph. Helv.). These texts have been further revised. The revised chapters 20 and 21 will be incorporated in the upcoming edition of the Ph. Helv, which will be published this year.(October 2026)

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 deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults

Alopecia areata is a disease where the body’s own immune system attacks hair follicles, causing inflammation that leads to hair loss on the scalp, face and/or other parts of the body.

Deuruxolitinib was approved to Sun Pharma UK Limited.

This medicine was approved via the International Recognition Procedure (IRP)

Conferences / webinars / workshops etc.

The PHSS Virtual Aseptic Processing Workshop 2026,

This virtual workshop taking place on 28th, 10:00-13:00 GMT & 29 April 2026 (10:00–12:00 GMT), will bring together leading industry experts and professionals for two half‑day sessions of insight, collaboration, and discussion. This year's virtual format ensures global accessibility while maintaining the depth and interactivity that define PHSS educational events.

Across the workshop, participants will explore how a clear understanding of aseptic processes underpins compliance, strengthens contamination control strategies, and reduces the likelihood of inspection failures. Recent regulatory observations reveal consistent deficiencies: insufficient justification of aseptic practices, weak operator controls, poor environmental discipline, and ineffective integration of risk assessment. These findings highlight the critical importance of both foundational design and practical execution, ensuring that each step is grounded in knowing why it exists and how it contributes to sterility assurance.

Through dedicated topic sessions covering facility design, cleanroom classification, contamination control, operator qualification, and a lifecycle approach to sterility assurance, attendees will gain a structured understanding of how each component supports an effective Contamination Control Strategy (CCS).

Protective Airflow including First Air Visualisation Virtual Training

This PHSS training course provides insight into the characteristics of Protective airflow, including First Air protection as defined in EU GMP & PICS Annex 1, and considers the design and qualification of airborne contamination control in Aseptic manufacturing.

The course aligns with training provided by the PHSS to international regulatory authorities on Airflow visualisation, supporting published research on the characterisation of protective airflow and 'First Air', and using a set of 'Rules' to provide a framework for acceptance criteria in airflow visualisation studies.

The airflow visualisation research presented applies the science of Computational Fluid Dynamics (CFDs) and its connection to Smoke

study airflow visualisations.

The value of CFD in the design phase to improve aerodynamics, provide knowledge of airflow patterns: flow vectors and velocity profiles to improve protective airflows, including First Air protection, which in turn provides better Airflow visualisation, Smoke study outcomes are increasingly recognised by industry and regulators. This training course 18th & 19th May, 09:00 - 12:00 BST,will be repeated on 29th and 30th June.

Registration is free for worldwide drug regulatory bodies 

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.