Review of Developments in GMP and the Regulation of Medicines July 2026
INTRODUCTION
The topics covered in this edition of the “Update” have come from the UK, EU, USA Australian and Swiss regulatory authorities.
Medicines and Healthcare Regulatory Authority (MHRA)
Pioneering AI health innovations regulatory sandbox launched
MHRA landmark report reveals public views on AI in healthcare
Unique liaison programme between MHRA and US FDA
Warning on promoting newly licensed prescription-only medicines and unlicensed medicines for weight management
MHRA Innovation Office: guidance and support
Borderline products: medical devices and other products
European Medicines Agency (EMA)
2025 AI Observatory report
EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines
EMA’s 2025 annual report
Reform of the EU pharmaceutical legislation
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
The Pharmacopoeial Discussion Group (PDG) interim videoconference on 24 March 2026
Certification monthly report of activities: End of May 2026
Reference standards
EDQM publishes guidelines to increase reporting on disappearances of medicinal products from the legal supply chain
Ireland
Health Products Regulatory Authority (HPRA)
Safety warning to consumers on teeth whitening products
Certain Postapproval Requirements and Resources for ANDAs
Forms FDA 3542a and FDA 3542: Q&As
Australia
Therapeutic Goods Administration(TGA)
Consultation on increasing transparency of GMP inspection outcomes
Consultation: Radiopharmaceutical regulation in Australia
Switzerland
Swissmedic
Project Orbis guidance document updated
swissdamed Webinar 28 May 2026
SEND datasets for new authorisation applications for human medicinal products with new active substances
Cross-agency targeted campaign "Peptides 2026
Resmetirom (Rezdiffra) -MHRA
Nipocalimab (Imaavy) authorised to treat adults and adolescents with generalised myasthenia gravis
Lower dose needle-free allergy treatment approved for younger children
The UK’s first GLP-1 receptor agonist tablet for weight loss and weight management has been approved by the MHRA.
Conferences
EDQM Symposium: Microbiology on the Move
EDQM Webinar: high-throughput sequencing for the detection of extraneous agents under Ph. Eur. general chapter 2.6.41
RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS
RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS
UK
Medicines and Healthcare products Regulatory Agency (MHRA)
Pioneering AI health innovations regulatory sandbox launched
The London sandbox is a secure environment designed to safely test AI-enabled devices in a real-world environment so patients can benefit more quickly.
The initiative, known as London Region I, will create a real-world environment to safely deploy AI-enabled medical devices while generating additional evidence of benefit across NHS settings, helping ensure patients can access new technologies earlier while maintaining the highest standards of safety.
Up to 10 AI medical device manufacturers will be selected to participate in the initial phase, working alongside NHS providers across London to deploy technologies in live clinical settings under MHRA oversight. MHRA will be inviting expressions of interest from both NHS providers and AI medical device manufacturers interested in participating in London Region I next month.
MHRA landmark report reveals public views on AI in healthcare
The MHRA has launched two reports describing the findings of an extensive engagement and evidence gathering programme undertaken to inform future rules on how AI can be used safely in healthcare.
The over-arching view of these contributions is a recognition of the potential benefits of AI in healthcare, provided that rules appropriately set standards for safety and efficacy. There is a broad consensus that existing regulatory approaches need to be adapted to meet the rapid pace of change and development of AI technology.
Unique liaison programme between MHRA and FDA
MHRA and US FDA have announced a new liaison programme, marking a significant step forward in strengthening the regulatory partnership between the UK and the USA.
The programme will establish dedicated, reciprocal liaison officer roles within each organisation.
The roles aim to enhance day-to-day collaboration, support scientific exchange and enable faster, more coordinated approaches to emerging regulatory challenges and decisions.
By strengthening communication and sharing regulatory insight more effectively, the programme will help both organisations respond more quickly to advances in science and technology and support the development of safe, effective products for patients across both countries.
Importantly, both agencies will maintain full regulatory independence, while enabling closer alignment and collaboration where it delivers clear public health benefit.
Warning on promoting newly licensed prescription-only medicines and unlicensed medicines for weight management
The MHRA, Advertising Standards Authority, and the General Pharmaceutical Council have issued a warning to businesses seeking to promote newly authorised medicines, as well as those that do not yet have a marketing authorisation.
They have seen recent examples of businesses promoting:
· pipeline products, such as newer forms of oral and injectable products used for weight management, including waiting lists for these products, and
· newly licensed oral GLP-1s, which are prescription-only medicines (POMs).
The CAP Code is clear that medicines must have a licence from the MHRA before they are marketed (rule 12.11) and that prescription-only medicines or prescription-only medical treatments cannot be advertised to the public (Rule 12.12).
They are jointly emphasising the importance of reviewing advertising as a matter of priority to ensure all advertisers in the sector work within the rules.
MHRA Innovation Office: guidance and support
The Innovation Office is open to queries relating to products or technologies that challenge the current regulatory framework, particularly those early in their development phase or in areas of regulatory uncertainty or fields undergoing rapid change. We can provide regulatory advice if you are developing a product which uses new or novel technology, materials, methods or approaches or manufacturing processes.
MHRA updated these pages in June with more information and to improve ease of use.
Borderline products: medical devices and other products
This guidance explains when a product would be considered a medical device within the terms of Part II of the Medical Device Regulations 2002.
This guidance is specific to products placed on the market in Great Britain (England, Wales and Scotland).
The guidance was updated in June. Updates relate to pre-injection swabs and wipes which has been changed from – ‘Alcohol-only pre-injection swabs and wipes are considered to be medical devices as are those containing anti-microbial substances such as chlorhexidine, cetrimide or iodine.' To ‘Alcohol-only pre-injection swabs and wipes are considered to be medical devices.’
Europe
European Medicines Agency (EMA)
2025 AI Observatory report
Artificial Intelligence (AI) is fast evolving and is rapidly transforming the development and supervision of medicines. The EU AI Act entered into force in 2024 and represents a significant step towards ensuring that AI is developed and used in a trustworthy, transparent and ethical way, while encouraging its uptake and creating a supportive environment for innovation. In 2025, it moved from adoption to practical application.
To keep abreast of such change and to support the development and evaluation of AI in the medicines’ lifecycle, every year the Network Data Steering Group (NDSG) monitors information on activities, trends and emerging AI domains and publishes the network ‘AI observatory’
In line with the NDSG workplan, the 2025 AI Observatory report provides an overview of guidance and policy, applications of AI, ongoing collaborations and engagement activities with stakeholders and partners, as well as a high-level overview of progress in EU-funded initiatives and regulatory science research. It covers both the human and veterinary domains and does not attempt to be a comprehensive and systematic review of all applications of AI. However, further details are included in the Annexes.
EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines
In 2025, EMA recommended 104 human medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before.
EMA’s efforts further extended to global public health, with three positive opinions for medicines intended for use outside the EU.
On the veterinary side, EMA recommended 30 medicines for marketing authorisation – the highest number of recommendations for a second consecutive year. Of these, 13 had a new active substance.
Sixteen of the veterinary medicines were vaccines, which was an increase from 14 vaccines in 2024. Seven of the vaccines were approved under exceptional circumstances to respond to animal health emergencies.
The report also contains the major achievements of EMA’s scientific committees for 2025 and highlights their strategic goals for the years ahead.
In addition, the report highlights the Agency’s preparation for the implementation of the new pharmaceutical legislation and explores how digitalisation and AI continued to transform EMA’s work in 2025 – moving from exploration to practical application.
EMA’s 2025 annual report
Highlights of the June 2026 meeting have now been published
Reform of the EU pharmaceutical legislation
Latest information on the upcoming changes introduced by the European Union's (EU) comprehensive overhaul of its pharmaceutical legislation.
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
The Pharmacopoeial Discussion Group (PDG) interim videoconference on 24 March 2026
The discussions focused on strategy and policy issues as the PDG continues to develop its activities beyond its original harmonisation mandate — expanding membership, engaging with ICH Q4B, and broadening its global outreach. The Korean Pharmacopoeia (KP) also provided feedback on the timeline and challenges associated with its Observing Phase participation in PDG These discussions will inform the continued planning and coordination of PDG activities.
Certification monthly report of activities: End of May 2026
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Reference standards
Nine new European Pharmacopoeia reference standards and fourteen replacement batches were released in May 2026
EDQM publishes guidelines to increase reporting on disappearances of medicinal products from the legal supply chain
The disappearance of medicines – whether through theft, loss or diversion – poses a serious risk to public health. Medicines that leave the legal supply chain may reappear through unregulated channels, increasing the availability of unsupervised, falsified or otherwise compromised products and undermining trust in healthcare systems and the integrity of the pharmaceutical supply chains.
The recommendation and accompanying guidelines address these risks by promoting systematic reporting of all incidents and encouraging data centralisation at national level, allowing NCAs and governments to take informed decisions to prevent and respond to such events. They also emphasise the importance of strengthened co-operation at national and international level, including the use of existing tools and networks.
Ireland
Health Products Regulatory Authority (HPRA)
Safety warning to consumers on teeth whitening products
The HPRA is warning consumers to exercise caution when purchasing teeth whitening products, following new figures which show that illegal and potentially unsafe products, containing high levels of hydrogen peroxide, are entering the Irish market through online sales. Due to potential harmful side effects from hydrogen peroxide, the HPRA advises consumers to consult a dentist before considering teeth whitening - especially if they have existing dental or medical conditions.
The HPRA states that in 2025, it detained 6,849 units of teeth whitening products and was involved in removing 105 website URLs connected to the sale and supply of non-EU compliant teeth whitening products. These products, typically sold as strips or gels, are often marketed online, including through social media platforms.
Hydrogen peroxide is the active bleaching ingredient used in teeth whitening kits and gels. While effective, it is tightly regulated in the E U to protect consumer health. Higher concentrations of hydrogen peroxide in teeth-whitening products are associated with an increased risk of adverse effects. A common side effect of teeth whitening is sensitivity; however, hydrogen peroxide may cause inflammation, pain, gum irritation and chemical burns when concentrations are too high.
United States of America
The US Food and Drug Administration (USFDA)
Certain Postapproval Requirements and Resources for ANDAs
This final guidance is intended to assist holders of abbreviated new drug applications (ANDAs) by highlighting certain postapproval statutory and regulatory requirements for ANDAs, as well as by identifying related guidances and other resources available to reference.
Historically, FDA has highlighted certain postapproval requirements in ANDA approval letters. The letters have included general and largely standardized information to serve as reminders to ANDA holders of certain postapproval statutory and regulatory obligations. In an effort to streamline ANDA approval letters, the Agency has been removing some of the information on postapproval requirements typically included in the letters, while continuing to provide ANDA holders with a helpful resource to reference for reminders about certain postapproval requirements.
Forms FDA 3542a and FDA 3542: Q&As
This draft guidance is intended to assist new drug application (NDA) applicants and NDA holders in submitting patent information to their NDAs using the appropriate forms.
This guidance provides answers to commonly asked questions regarding Forms FDA 3542 and FDA 3542a.
International
Australia
Therapeutic Goods Administration (TGA)
Consultation on increasing transparency of GMP inspection outcomes
Consultation period: 10 June 2026
- 13 July 2026
TGA are seeking feedback on our proposal to increase transparency of GMP compliance of manufacturers of pharmaceutical products on the TGA website.
TGA are seeking views on:
· how GMP certificates and inspection outcomes should be displayed and accessed
· how to ensure published information is clear, accurate and does not disclose confidential information
· any potential benefits or impacts of publishing this information.
A key point for consideration is:-
The TGA is now proposing to publish the outcomes of all GMP inspections and the GMP certificates for international manufacturing sites. This is in response to increased public interest in regulatory transparency and to strengthen public confidence in the oversight of domestic and international manufacturing sites. The proposed approach is consistent with international regulatory practice. Publishing GMP certificates for international manufacturing sites would provide equivalent visibility to that currently available for Australian manufacturers.
Consultation: Radiopharmaceutical regulation in Australia
Consultation period: 5 June 2026 - 31 July 2026.
TGA are seeking stakeholders’ feedback on the regulation of radiopharmaceuticals in Australia. Radiopharmaceuticals are medicines that contain small amounts of radioactive material and are used to support the diagnosis and treatment of serious conditions, including cancer and cardiovascular disease.
To support stakeholder feedback, the TGA has provided an information paper outlining, at a high level, how current regulatory pathways operate in practice. The paper is intended to assist stakeholders and should be considered alongside relevant legislation and guidance.
Switzerland
Swissmedic
Project Orbis guidance document updated
Swissmedic has revised the Project Orbis guidance document. In particular, the process for applications for the Project Orbis procedure is described in greater detail. The structure of the guidance document has also been modified as part of updating, and editorial changes have been made in various sections to improve clarity. The modifications that have been made do not constitute changes to the requirements for applications for the Project Orbis procedure.
The revised Project Orbis guidance document will take effect on 1 June 2026.
swissdamed Webinar 28 May 2026
Swissmedic hosted a free online training on how to register medical devices in swissdamed.
The training is designed for anyone responsible for UDI submissions in swissdamed.
This webinar offers instructions on how to register medical devices in swissdamed. The webinar was recorded and is now publicly available on the Swissmedic website
SEND datasets for new authorisation applications for human medicinal products with new active substances
From 15 June 2026, submission of non-clinical study data in SEND format for new authorisation applications for human medicinal products with new active substances will be mandatory if submission to the FDA is planned or if the submission has already been made.
Swissmedic is therefore not requiring additional data but following the current Data Standards Catalog of the US FDA.
Cross-agency targeted campaign "Peptides 2026"
Swissmedic and SSI warn of the health risks associated with illegally imported peptides and conduct a joint campaign with FOCBS
Swissmedic, together with the Federal Office for Customs and Border Security (FOCBS), and Swiss Sport Integrity (SSI) conducted a targeted campaign against illegally imported peptides. In the campaign, shipments suspected of containing illegally imported peptides or comparable substances were subjected to targeted checks. The findings showed that such products are increasingly ordered from unregulated online channels.
These products are often unauthorised, with no guarantee of quality and pose considerable health risks.
The results confirm a trend that Swissmedic, FOCBS and SSI have been aware of for some time: products that straddle the line between medicines, lifestyle offers and doping agents are increasingly being ordered from online channels by private individuals in Switzerland.
Peptide-like substances advertised on websites, social media or messaging services are often inadequately tested for use in humans and are not authorised as medicinal products in Switzerland. Swissmedic and SSI want to raise public awareness and warn against ordering peptides or comparable substances via websites, social media or messaging services from unknown suppliers. Unauthorised products are not a safe shortcut to more performance, a better appearance or faster regeneration since they pose considerable health risks.
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]
Resmetirom (Rezdiffra)
MHRA has authorised resmetirom (Rezdiffra) to treat adult patients with metabolic dysfunction-associated steatohepatitis (MASH).
MASH is a liver disease where fat builds up in the liver, which can result in inflammation and damage to the liver cells. It is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction.
The authorisations, of resmetirom 60 mg, 80 mg and 100 mg film-coated tablets, were approved under the International Recognition Procedure (IRP). These new marketing authorisations were granted to Madrigal Pharmaceuticals EU Limited.
Nipocalimab (Imaavy) authorised to treat adults and adolescents with generalised myasthenia gravis
Myasthenia gravis is an autoimmune disease in which the immune system disrupts communication between nerves and muscles, causing muscle weakness and tiredness. It most commonly affects the muscles that control the eyes and eyelids, facial expressions, chewing, swallowing, and speaking, but it can affect most parts of the body.
Nipocalimab binds to a protein in the body called the neonatal Fc receptor (FcRn). This binding reduces levels of IgG autoantibodies - immune system proteins that mistakenly attack the body’s own tissues. By doing this, the medicine can improve the ability of muscles to contract and reduce the symptoms of the disease and their impact on daily activities.
The new marketing authorisation was granted to Janssen-Cilag Limited. This application was approved under the International Recognition Procedure (IRP)
Lower dose needle-free allergy treatment approved for younger children
MHRA has approved a new lower dose version of the adrenaline (epinephrine) nasal spray, EURneffy, for the emergency treatment of serious allergic reactions (anaphylaxis) in children aged four years and over.
This approval means younger children are eligible for a needle-free treatment option for the first time in the UK.
The new marketing authorisation was granted to ALK-Abelló A/S.
The UK’s first GLP-1 receptor agonist tablet for weight loss and weight management has been approved by the MHRA.
The starting dose for the semaglutide tablet is 1.5mg once daily, increasing to 4mg, 9mg and 25mg with a minimum duration of one month at each dose level.
Patients currently treated privately with a 2.4mg semaglutide injection once weekly can be transitioned straight to semaglutide 25 mg tablets once daily.
Authorisation for this new indication for the semaglutide (Wegovy) tablet was granted to Novo Nordisk.
Conferences / webinars / workshops etc.
EDQM Symposium: Microbiology on the Move
Registration is now open for this symposium, which will be held in Strasbourg from 13-15 October 2026. Organised by the EDQM & Council of Europe, the symposium offers a unique opportunity for regulators, industry representatives and other international stakeholders to explore how best to align practices and contribute to shaping the future direction of microbiological quality standards by directly addressing current challenges and emerging opportunities in this field.
Over the course of three days, participants will:
· review internationally harmonised pharmacopoeial chapters on microbiology
· explore rapid/alternative microbiological methods, with a focus on solutions for short-life products (e.g. ATMPs, radiopharmaceuticals) and emerging products (e.g. live biotherapeutics)
· benefit from a dedicated training session on the newly revised European Pharmacopoeia (Ph. Eur.) general chapter on Alternative Methods for control of microbiological quality.
EDQM Webinar: high-throughput sequencing for the detection of extraneous agents under Ph. Eur. general chapter 2.6.41
EDQM will host a free, live webinar on the European Pharmacopoeia’s (Ph. Eur.) new general chapter High-throughput sequencing for the detection of viral extraneous agents (2.6.41). Participants will gain a practical overview of this new chapter in which high-throughput sequencing (HTS) methods for the detection of viral extraneous agents in biological products are described, as well as their validation. 3 September 2026 (13:00 to 14:30 CEST, Paris, France). Places are limited, so register early to secure your spot!
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.
Comments