Review of Developments in GMP and the Regulation of Medicines August 2026
INTRODUCTION
The topics covered in this edition of the “Update” have come from the UK, EU, USA, PIC/S and Australian regulatory authorities.
Medicines and Healthcare Regulatory Authority (MHRA)
Making regulation a catalyst, not a barrier, for UK life sciences
Best Practice Guidance on Labelling & Packaging of Medicines.
MHRA Innovation Office
Safety review gives UK plasma donations go ahead
Medicines that you cannot export from the UK or hoard
Convictions secured after a decade-long investigation into falsely marked baby-feeding devices
Four sentenced to nearly 15 years combined jail time following major MHRA investigation into illegal online supply of medicines
Updated warnings for botulinum toxin products following rare cases of botulism
2025-26 Annual Report and Accounts confirms growing global influence
AI Airlock Sandbox Phase 2 Programme Report
Thousands of patients to benefit from new daily pill for serious heart condition following co-ordinated MHRA and NICE decisions
European Medicines Agency (EMA)
EMA steps up efforts on medicines for women’s health
Joint European Commission (EC) / EMA multi-stakeholder workshop on regulatory sandbox
17th Industry Standing Group (ISG) meeting
New Zealand – working agreement
GMP & GDP Q&A
Q&A for biological medicinal products
Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1.
Horizon scanning: Identifying emerging trends
Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products.
Concept paper on the revision of the guideline on pharmaceutical fixed combination products
(EMA/CVMP/83804/2005-Rev.1).
Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
CEP holders invited to comment on draft monographs published in Pharmeuropa 38.3
Reference standards(June /July)
Pharmeuropa 38.3 just released
European Pharmacopoeia Issue 13.2 now available
Second issue of Pharmeuropa EDSForm
Certification monthly report of activities: End of June 2026
Follow-up position paper on the consequences of implementing the EU’s Medical Device Regulation for the substances of human origin sector
Outcome of the 185th session of the European Pharmacopoeia Commission
Publication of revised Ph. Eur. general chapter 5.1.6 on alternative microbiological methods
Deployment of a new EDQM CEP database feature: full download of CEP data
A hearing on the European Pharmacopoeia Excipient Strategy
Ireland
Health Products Regulatory Authority (HPRA)
New guidance on controlled drugs requirements
Labelling requirements for cosmetic products containing fragrances covered under Regulation (EU) 2023/1545
Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs - Guidance for Industry
Australia
Therapeutic Goods Administration(TGA)
Adoption of International Scientific Guidelines in Australia - R01/2025
New information relating to s 9D(1) applications for listed medicines
Take control of your learning journey and understand your regulatory obligations
New UDI requirements for medical devices commence.
Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
Concept paper on the revision of EU-PIC/S GMP Annex 15 (Qualification and validation) - Corrigendum
Revision of PIC/S Recommendations on Qualification and Validation (PI 006-4)
2026 PIC/S Seminar (Istanbul / Türkiye)
United Arab Emirates applies for PIC/S Pre-Accession
Uzbekistan applies for PIC/S membership
Gemcitabine delivery system for adults with BCG-unresponsive high-risk non-muscle invasive bladder cancer
Semaglutide (Wegovy) approved to treat form of liver disease
MHRA approves Retifanlimab (ZYNYZ) for the treatment of advanced Merkel cell skin cancer
Medicine for metastatic pancreatic cancer
Nerandomilast (Jascayd)
MHRA approves world's first lower-carbon beclometasone inhalers
Conferences
EDQM Workshop on quality management for tissues and cells
RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS
UK
Medicines and Healthcare products Regulatory Agency (MHRA)
Making regulation a catalyst, not a barrier, for UK life sciences
In a Guest lecture in the USA the MHRA CEO argues that for the UK’s long-term health and prosperity, regulation should help lead, rather than follow, innovation
The ability to navigate long-term trends in science and technology that will define our enduring success in a highly competitive geopolitical future.
That will require both policy changes and rethinking some of the barriers that have held us back, including our approach to balancing risk with the benefits of innovation. And it will require a thoughtful and open approach to harnessing the benefits of AI.
We are in a period of extraordinary scientific discovery, helping us predict, prevent, diagnose, treat and cure diseases more effectively than we could have dreamt of a generation or two ago.
Best Practice Guidance on Labelling & Packaging of Medicines.
This guidance in PDF format was revised and published June 2026
The purpose of this guidance is to support a move to more self-regulation by the pharmaceutical industry of changes to labelling and packaging of medicines.
When the guidance is applied, it will help to ensure that the critical information necessary for the safe use of the medicine is legible, easily accessible and that users of medicines are assisted in assimilating this information so that confusion and error are minimised.
In preparing this guidance, it is acknowledged that different users of medicines require and use information differently. This guidance has been drafted to support the legal framework set out in national legislation. It should be taken into account by MAHs when preparing the labelling provided with Marketing Authorisation applications and variation submissions or when submitting notifications or applications under Regulation 267 of the HMRs.
The guidance applies equally to prescription only medicines (POM) and those available over-the-counter (OTC).
See also:
Guidance for submitting changes to labels and Patient Information Leaflets (PILs) as a self-certification and, Applying for Changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
MHRA Innovation Office
The MHRA’s Innovation Office offers access to expert regulatory guidance for developers of innovative medicines and novel manufacturing processes that face regulatory challenges, uncertainties, or gaps in the current regulatory framework The Innovation Office is part of the MHRA’s Innovation Accelerator which supports queries regarding innovative medicines, medical devices, and novel manufacturing processes that face regulatory challenges, uncertainties, or gaps in the current regulatory framework. This service is available to organisations of all backgrounds and sizes based nationally or internationally including academics, not for profit organisations, and patient groups involved in research and industry
Safety review gives UK plasma donations go ahead
Following an extensive safety review, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of UK‑donor plasma for five high‑priority medicines, helping to strengthen supplies of life-saving treatments used by thousands of critically ill patients each year.
The decision, follows an assessment of the potential risk of variant Creutzfeldt‑Jakob disease (vCJD). Independent experts concluded that the risk of transmission through these products is negligible.
A precautionary ban on the use of UK-sourced plasma for manufacturing these medicines has been in place since 1999, requiring reliance on imported plasma at a time of growing global demand. Restrictions have been lifted for immunoglobulin and human albumin products in 2021 and 2023 respectively. This latest decision extends the use of UK plasma for these essential treatments. Allowing the use of plasma from UK blood donors for the manufacture of Fibrinogen, Prothrombin Complex Concentrates (PCCs), C1 Esterase Inhibitor, Factor X and Protein C, will aid supply and reduce reliance on imports from other countries.
Medicines that you cannot export from the UK or hoard
During July the list was updated
· to remove: Glucagon (strength: all, pharmaceutical form: powder for injection, solution for injection); and Terbutaline (strength: 500micrograms/1ml and 2.5mg/5ml, pharmaceutical form: solution for injection ampoules).
· to add: Cyclophosphamide (strength: 1g/2g/500mg; pharmaceutical form: powder for solution for injection vials).
Convictions secured after a decade-long investigation into falsely marked baby-feeding devices
MHRA has secured convictions following a long running investigation led by its Devices Compliance Unit into the illegal supply of medical devices used in hospitals across the UK.
Kenneth George Harrison of Bolton, and Medicina Limited were found guilty of a number of fraud offences after supplying medical devices with false CE markings and misleading healthcare providers about their safety and regulatory approval.
This case is the result of years of detailed investigative work by the MHRA, which first identified concerns in 2013 and continued to pursue the case to its end.
Throughout the investigation, the MHRA took action to protect patients, including issuing safety alerts, overseeing recalls and instructing the company to stop further supply of the devices.
MHRA have also commenced confiscation proceedings under the Proceeds of Crime Act to recover any available funds from this criminal activity.
[Good to see that confiscation proceedings under the Proceeds of Crime Act have commenced too. MBH]
Four sentenced to nearly 15 years combined jail time following major MHRA investigation into illegal online supply of medicines
Four members of an organised criminal group have been sentenced at Wolverhampton Crown Court for their roles in a large-scale operation that supplied controlled drugs, prescription-only medicines (POMs) and unauthorised medicinal products online. These sentences come after convictions were secured in Nov 2025, following a major investigation by the MHRA’s Criminal Enforcement Unit (CEU).
Updated warnings for botulinum toxin products following rare cases of botulism
Botulinum toxin medicines are widely used in both medical treatments and cosmetic procedures. However, in very rare cases, the toxin’s effect may spread beyond the injection site, causing botulism, a serious and potentially life-threatening condition.
The MHRA has worked with manufacturers to update product information, including patient leaflets, to more clearly highlight the risk of iatrogenic botulism (botulism caused by medical treatment).
2025-26 Annual Report and Accounts confirms growing global influence
MHRA has published its 2025–26 Annual Report and Accounts highlighting a year of strong and consistent delivery as set out in the agency’s first Results and Forecast report earlier this year.
AI Airlock Sandbox Phase 2 Programme Report
The AI Airlock programme report contains a comprehensive overview of the methodology for establishing the regulatory sandbox, an overview of the seven case studies and the lessons learned from the independent programme evaluation. The report also summarises the key technical and regulatory insights and recommendations for changes to the regulatory and support framework for AI as a medical device.
Also included on this page is the detailed innovator case study reports. These have been drafted by the innovators and do not constitute MHRA guidance or policy.
The AI Airlock Phase 2 programme report has been updated in July 2026 to amend the engagement route into the MHRA included within recommendation 20.
Thousands of patients to benefit from new daily pill for serious heart condition following co-ordinated MHRA and NICE decisions
Around 6,600 people in England with a serious heart condition will be able to access a new treatment following simultaneous MHRA authorisation and NICE approval.
Aficamten, also known as MYQORZO, is a once-daily pill for people with obstructive hypertrophic cardiomyopathy (HCM) - a condition where the heart muscle becomes thickened and stiff, making it harder for the heart to pump blood around the body.
NICE used a cost comparison approach for this drug, where to get a positive recommendation, the company needed to demonstrate the costs for aficamten are similar to or lower than those for mavacamten for treating symptomatic HCM.
NICE has published final guidance two weeks faster than its standard processes due to efficiencies gained through a closer working relationship with the MHRA.
Europe
European Medicines Agency (EMA)
EMA steps up efforts on medicines for women’s health
EMA is launching initiatives to better embed women’s health considerations in medicines development and regulation. Women live longer than men on average but spend more of their lives in poorer health. This disparity is due to societal aspects as well as gaps in disease prevention, diagnosis, and treatments, which do not always fully address the specific health needs of women.
Joint European Commission (EC) / EMA multi-stakeholder workshop on regulatory sandbox
The aim of this workshop on 21 September 2026, is to discuss aspects of the implementation of EU regulatory sandboxes as laid out in the revised pharmaceutical legislation, how sandboxes work, and what is necessary to implement and execute them effectively.
Registration is by invitation only.
Video recording is published after the event.
17th Industry Standing Group (ISG) meeting
The Industry Standing Group (ISG) is a forum for interaction that has been established as part of the EMA's continuous improvement for engagement with industry stakeholders supply chain of human, veterinary and medical device sectors on activities within EMA's responsibilities. It aims to facilitate regular exchange of views and promote dialogue on new and upcoming legislation, including:
· New Pharmaceutical Legislation (EU)
· EMA Mandate extension (Regulation (EU) 2023/123)
· HTA Regulation (Regulation (EU) 2021/2282)
The ISG is also the forum to discuss other topics of mutual strategic interest to the Agency and the industry stakeholders.
[There are 10 topic presentations that you can access - well worth a perusal MBH]
New Zealand – working agreement
The European Commission's Directorate-General for Health and Food Safety (DG-SANTE) and EMA have in place a working arrangement with the New Zealand Ministry of Health since 2026. The Ministry of Health incorporates the New Zealand Medicines and Medical Devices Safety Authority, Medsafe.
The arrangement enables exchange of information on medical and medicinal products between the EU and New Zealand authorities, as part of their regulatory and scientific processes.
It is a significant step towards mutual recognition and regulatory harmonisation between both regions.
The working arrangement is in effect as of 6 July 2026.
This Page was revised July 2026 to include information on the signature of a working arrangement between DG-SANTE, EMA and the New Zealand Ministry of Health
GMP & GDP Q&A
The following section has been updated :
EU GMP guide part I: Basic requirements for medicinal products: Chapter 5 Production: A new Question 5 has been added.
What are technical and organisational measures that should be taken into consideration to prevent microbial contamination of non-sterile medicinal products
Q&A for biological medicinal products
On 20 July 2026 the Section 'Active substance specification Host cell proteins testing' was updated.
Question 'What information on characterisation, biosimilarity, and comparability after manufacturing changes should be provided for effector functions of monoclonal antibodies' updated.
New sections added:
Endotoxin Limulus Amoebocyte lysate (LAL) test
Biosimilar acceptance criteria
Vaccine potency testing
Extractable volume testing
Viral filtration
Pre-use filter integrity testing
Adeno associated virus (AAV) infectious titre test
Changes to master cell banks
Biosimilars containing recombinant hyaluronidase
Reference standard qualification protocols
Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1.
Legal, regulatory and especially scientific developments require a revision of biosimilar guidelines.
The Guideline on similar biological medicinal products was last revised in 2015. Since then, major progress has been made in the analytical sciences and regulatory field of biosimilars.
This is especially evident from the following two developments: -
· The EMA Reflection Paper on a tailored clinical approach in biosimilar development and initiation of ICH M18 Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs.
· The New Pharmaceutical Legislation (NPL)1 which will amend the legal-regulatory definition of a biosimilar.
Therefore, the main intention is to provide updated high-level guidance regarding the necessity and utility of Comparative Efficacy Studies (CES) and recent regulatory experience obtained with Scientific Advices on biosimilar developments and CHMP decisions on biosimilar marketing authorisation applications (MAAs).
The guideline also needs to be updated to reflect the new legal definitions and associated high level data requirements for biosimilars in the NPL.
Horizon scanning: Identifying emerging trends
The EU Innovation Network (EU IN) of the European medicines regulatory network is conducting horizon scanning to identify emerging science, technologies and trends that may shape the future of human medicines.
Horizon scanning helps EMA and the European medicines regulatory network understand, anticipate and prepare for scientific and technological change.
It supports the network in identifying emerging innovations that may affect medicines development, regulation, manufacturing or patient access.
By detecting these developments early, the network can prepare for future regulatory challenges, support responsible innovation and help ensure that patients in Europe can benefit from safe, effective and innovative therapies.
Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products.
This concept paper addresses the need for a guideline on the quality and safety aspects of RNA13 interference and RNA antisense oligonucleotide therapies as veterinary medicinal products.
Based on a survey among industry stakeholders initiated by the Novel Therapies and Technologies Working Party (NTWP), RNA antisense and RNA interference therapies have been identified as the most advanced class of novel therapies with regard to their stage of development. Thus, CVMP identified the need for the development of a guideline specifically focusing on the quality and safety aspects. This concept paper addresses the need for a guideline on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products.
Concept paper on the revision of the guideline on pharmaceutical fixed combination products
(EMA/CVMP/83804/2005-Rev.1).
The objective of the current guideline is to outline the conditions and clarify the data requirements for efficacy, safety and residues documentation for pharmaceutical veterinary medicinal products containing two or more active substances (so called “fixed combination products”).
Although it is considered that the guideline is still relevant in most of its aspects, based on current scientific knowledge and regulatory experience certain sections would benefit from the inclusion of more detail to aid applicants in preparing applications and lead to a more predictable and consistent outcome
Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases
Seriously debilitating or life-threatening conditions are those associated with morbidity that has substantial impact on patients’ day-to-day functioning and will progress if left untreated, or those associated with a high likelihood of mortality.
There is currently no EMA position on how deviations from the core non-clinical ICH guidelines, M3 or S6, could be used to accelerate the development of therapeutics for severely debilitating or life-threatening diseases outside of the scope of ICH S9. A reflection paper would facilitate development of medicinal products in this area, help harmonise non-clinical development, support marketing authorisation applications and earlier patient access to potentially life altering or saving therapies, particularly in those indications where there is an unmet medical need.
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
CEP holders invited to comment on draft monographs published in Pharmeuropa 38.3 Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 38.3.Although these draft monographs are published for public consultation only at this stage and are therefore not official standards, they will, once adopted by the European Pharmacopoeia Commission, become legally binding standards for the substances concerned. It is therefore extremely important that manufacturers and users of the substances provide feedback on these draft monographs before the commenting deadline, i.e. before 30 September 2026.
Reference standards (June / July)
6 new Ph. Eur. reference standards and 25 replacement batches released in June 2026.
A further 10 new European Pharmacopoeia reference standards and 21 replacement batches released in July 2026
Pharmeuropa 38.3 just released
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 38.3 is 30 September 2026. Users and interested parties are welcome to comment on these drafts.
European Pharmacopoeia Issue 13.2 now available
The European Pharmacopoeia (Ph. Eur.) Issue 13.2 is now available and will be applicable in 39 European countries as of 1 April 2027.
Second issue of Pharmeuropa EDSForm
EDQM announces the release of the second issue of Pharmeuropa EDSForm. With this publication, two additional draft EDSForm monographs are being made available to users for public consultation.
Healthcare professionals and interested parties across Europe are invited to provide feedback on the draft monographs for Quetiapine capsules and Sulfamethoxazole/trimethoprim oral suspension.
Certification monthly report of activities: End of June 2026
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Follow-up position paper on the consequences of implementing the EU’s Medical Device Regulation for the substances of human origin sector
The European Committee on Organs, Tissues and Cells (CD-P-TO), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, has published a follow-up position paper examining Regulation (EU) 2017/745 on medical devices (MDR) and its implications for the substances of human origin (SoHO) sector. The document highlights the need for clearer guidance on how rules on medical devices should apply to devices deployed by SoHO entities.
The position paper builds on the committee’s previous work highlighting the risks that shortages of essential CE-marked devices used by SoHO entities in the context of their activities could pose to the safety and quality of SoHO activities, as well as to patients’ access to SoHO-based therapies. While the European Commission's proposal to revise the MDR addresses some of the concerns previously raised by the CD-P-TO, the committee considers that important issues remain regarding the interpretation of existing guidance on the application of MDR Article 5(5) to SoHO entities.
In particular, the position paper highlights two scenarios encountered in SoHO establishments: the deployment by health institutions of research use only (RUO) products for intended medical purposes, and the use of CE-marked medical devices beyond their manufacturer-defined intended purpose.
According to the committee, the current interpretation of these scenarios in theMDCG 2023-1 guidance document prepared by the European Commission’s Medical Device Coordination Group (MDCG) may create obligations that health institutions are unable to fulfil in practice. This could inadvertently curtail critical SoHO activities without providing additional patient safety benefits.
Outcome of the 185th session of the European Pharmacopoeia Commission
The European Pharmacopoeia Commission (EPC) held its 185th session on 23-24 June 2026. The Commission adopted 93 texts at this session, which will be published in Issue 13.3 (October 2026) of the European Pharmacopoeia (Ph. Eur.) and come into effect on 1 July 2027.
Of these 93 texts, 8 are new monographs and 3 are new general chapters:
The new general chapters are entitled Test for procoagulant activity in immunoglobulin preparations (2.6.42), Determination of estragole (2.8.27) and Phenolic antioxidants in plastic materials (2.5.46).
Publication of revised Ph. Eur. general chapter 5.1.6 on alternative microbiological methods
Alternative microbiological methods are increasingly used for pharmaceutical applications. To facilitate their implementation, the European Pharmacopoeia Commission (EPC) adopted the revised general chapter 5.1.6. Alternative methods for control of microbiological quality at its 184th session in March 2026. Published in Issue 13.2 of the European Pharmacopoeia (Ph. Eur.) in July 2026, the revised general chapter has an implementation date of 1 April 2027.
As part of this revision, the description of technologies has been comprehensively updated to remove outdated methods no longer used in quality control and to incorporate modern approaches.
To support stakeholders, a training session on the revised chapter will be held during the EDQM Micrrobiology Symposium (13-15 October 2026).
Deployment of a new EDQM CEP database feature: full download of CEP data
To further improve access to database information, the EDQM has introduced a new feature that enables users to download the complete dataset. The download includes the main information associated with each CEP, such as the CEP number, holder and status, the European Pharmacopoeia monograph number and substance name.
By clicking on the “Download CEP data file” link users can generate a .TXT file containing the full dataset. This file can be easily opened in spreadsheet software or processed automatically by data management software systems.
A hearing on the European Pharmacopoeia Excipient Strategy
EDQM is pleased to announce an in-person hearing on the European Pharmacopoeia (Ph. Eur.) Excipient Strategy, to be held at its premises in Strasbourg, France, on 28 January 2027.
In principle, the approach applied to excipients is similar to that used for active substances. However, some requirements do not fully address the intended uses and specific characteristics of excipients, such as their functionality and interactions with other ingredients.
At the hearing, the EDQM will gather feedback from stakeholders on the draft recommendations before they are finalised and submitted as the Ph. Eur. Excipient Strategy to the EPC for adoption.
Ireland
Health Products Regulatory Authority (HPRA)
New guidance on controlled drugs requirements
The HPRA has published a new guidance document for operators on the documentation, storage and security requirements for controlled drugs, helping licence and registration holders meet their obligations under the Misuse of Drugs Act 1977 (as amended), and other Orders and Regulations made under it.
The updated document follows a targeted consultation held in February 2026, during which the HPRA sought feedback from controlled drug operators and representative groups.
Labelling requirements for cosmetic products containing fragrances covered under Regulation (EU) 2023/1545
The HPRA has published a new information page to help members of the cosmetics industry comply with the fragrance allergen labelling requirements introduced under Regulation (EU) 2023/1545.
The Regulation expands the list of fragrance allergens requiring declaration on cosmetic product labels to more than 80 substances. The changes aim to strengthen consumer protection by enabling individuals sensitised to specific allergens to identify and avoid triggering substances.
The new webpage provides clarification on regulatory requirements and addresses frequently asked questions.
United States of America
The US Food and Drug Administration (USFDA)
Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs - Guidance for Industry
This final guidance provides recommendations to industry on formal meetings between the FDA and sponsors or requestors of nonprescription drugs without approved new drug applications that are governed by section 505G of the Federal Food, Drug, and Cosmetic Act or organizations nominated by sponsors or requestors to represent their interests in a proceeding.
This guidance discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings between FDA and meeting requesters. In doing so, it describes procedures under which meeting requesters can meet with appropriate FDA officials to obtain advice on the studies and other information necessary to support submissions under section 505G of the FD&C Act, to obtain advice on other matters relevant to the regulation of OTC monograph drugs, and to obtain advice on the development of new OTC monograph drugs. This guidance also applies to meetings with FDA to obtain advice on clinical investigations that may be conducted under an investigational new drug application (IND) where the purpose of the IND is to conduct a clinical investigation to support a determination whether there are conditions under which a nonprescription drug is generally recognized as safe and effective (GRASE). This guidance
specifies procedures to facilitate efficient participation in joint meetings by multiple meeting requesters and/or organizations nominated by them to represent their interests.
International
Australia
Therapeutic Goods Administration (TGA)
Adoption of International Scientific Guidelines in Australia - R01/2025
The TGA has adopted 23 international scientific guidelines following a public consultation process between 24 November 2025 – 10 February 2026.
While international scientific guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements. Any deviation from a guideline relevant to an application to register or vary the registration of a medicine must be justified.
New information relating to s 9D(1) applications for listed medicines
The TGA has released a new information page relating to the availability of s 9D(1) of the Therapeutic Goods Act 1989 to correct information in the Australian Register of Therapeutic Goods (ARTG) about listed medicines.
Take control of your learning journey and understand your regulatory obligations
TGA has launched a series of interactive e-learning modules designed to help stakeholders understand their regulatory obligations.
Whether you're new to regulatory processes or looking to refresh your knowledge, these modules offer a self-paced, structured learning experience to help you navigate complex topics with clarity and confidence.
They are designed to help sponsors, manufacturers and other stakeholders understand how we regulate therapeutic goods in Australia. They also explain key responsibilities for compliance, advertising and inspections.
New UDI requirements for medical devices commence.
From 1 July 2026, some medical devices supplied in Australia must meet Unique Device Identification (UDI) requirements. The introduction of UDI will begin with higher‑risk medical devices (Class IIb and Class III) followed by lower-risk medical device (Class IIa, Class Is and in vitro diagnostic devices) over later years.
UDI can support consumers, health professionals, industry and other stakeholders to more easily access accurate and up‑to‑date information about medical devices.
UDI requirements will be progressively rolled out to other medical device classifications over the coming years.
Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
Concept paper on the revision of EU-PIC/S GMP Annex 15 (Qualification and validation) - Corrigendum
This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 15 - Qualification and validation, 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 extend the scope of the annex to active substances manufacturers and to consider the revision of ICH Guideline Q9 (R1) on quality risk management. This concept paper was submitted to a joint EMA - PIC/S public consultation and comments have been collected until 9 April 2026. Following the public consultation, the initial timetable has been revised, and only this section has been updated accordingly.
Revision of PIC/S Recommendations on Qualification and Validation (PI 006-4)
These Recommendations have been revised by a dedicated PIC/S Working Group, successively chaired by Norman Gray (UK / MHRA) and subsequently jointly chaired by Kevin O’Donnell (Ireland / HPRA) and Rebecca Dowd (USA / US FDA). They supersede the PIC/S Recommendations on Validation Master Plan; Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation (PI 006-3).
PI 006-4 will enter into force on 1 October 2026.
2026 PIC/S Seminar (Istanbul / Türkiye)
Registrations for the 2026 PIC/S Seminar on “Digital Transformation in GMP” which will be hosted by Türkiye / TMMDA from 4-6 November 2026 are now open (for Medicines Regulatory Authorities only).
United Arab Emirates applies for PIC/S Pre-Accession
On 15 July 2026, a Rapporteur was appointed by written procedure for the pre-accession application of Emirates Drug Establishment (EDE), for which a pre-accession application was received on 5 March 2026.the designation of the Rapporteur marks the start of the pre-accession process.
Uzbekistan applies for PIC/S membership
On 17 December 2025, the State Entity “Center of Good Practices” of the Pharmaceutical Industry Development Agency under the Ministry of Health of the Republic of Uzbekistan and the State Institution “Center for Pharmaceutical Products Safety” under the Ministry of Health of the Republic of Uzbekistan, submitted a joint membership application to PIC/S.
Rapporteurs and Audit Team are in the process of being appointed
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]
Gemcitabine delivery system for adults with BCG-unresponsive high-risk non-muscle invasive bladder cancer
MHRA has authorised an intravesical delivery system containing gemcitabine (Inqlexzo) for the treatment of adults for certain types of bladder cancer who are ineligible for - or have chosen not to undergo - radical cystectomy.
The intravesical delivery system containing gemcitabine is placed into the bladder by a healthcare professional using a catheter. The system provides sustained local release of gemcitabine over approximately three weeks before being removed by cystoscopy.
These new marketing authorisations were granted to Janssen-Cilag Ltd.
This product was submitted and approved via the International Recognition Procedure (IRP) Route B.
Semaglutide (Wegovy) approved to treat form of liver disease
MHRA has approved a semaglutide injection (Wegovy) to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis (scar tissue in the liver).
Semaglutide has existing authorisations for weight management in adults and adolescents and for the reduction of cardiovascular events in adults.
Semaglutide has been approved to treat MASH on the condition that further results from an ongoing study in adults with MASH and moderate to advanced liver scarring will be submitted. The product has a conditional marketing authorisation because further confirmatory evidence is required of its efficacy and safety as a treatment for MASH before a full marketing authorisation can be issued. The MHRA will review new information on this medicine at least every year and the Summary of Product Characteristics will be updated, as necessary.
Authorisation for this new indication for semaglutide (Wegovy) was granted on 3 July 2026 to Novo Nordisk.
MHRA approves Retifanlimab (ZYNYZ) for the treatment of advanced Merkel cell skin cancer
Merkel cell carcinoma (MCC) is a rare and aggressive type of skin cancer that develops from Merkel cells, specialised neuroendocrine cells found in the top layer of the skin. Retifanlimab works by helping the body’s immune system recognise and attack cancer cells. It blocks a pathway that cancer cells can use to avoid being detected by the immune system, allowing immune cells to better identify and destroy them. Retifanlimab is administered via diluted intravenous infusion over 30 minutes.
The approval was granted to Incyte Biosciences UK Ltd.
This product was submitted and approved via International Recognition Procedure (IRP).
Medicine for metastatic pancreatic cancer
EMA’s human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer.
A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases, as they become available. EMA’s decision is based on the results of a phase 3 study which compared daraxonrasib with chemotherapy in patients with metastatic pancreatic cancer who had received prior treatment.
People with metastatic pancreatic cancer whose disease progressed after previous treatment have very limited treatment options and a poor prognosis, with a life expectancy of about 6 months. There is therefore a significant unmet medical need for these patients.
Medicines assessed under phased reviews are subject to the same standards for quality, safety and efficacy as any other medicine.
The overall review timeline for daraxonrasib cannot be anticipated; however, the process is expected to be shorter than a regular evaluation since part of the assessment will be carried out before the complete marketing authorisation application is submitted.
The applicant for daraxonrasib is Revolution Medicines.
Nerandomilast (Jascayd)
MHRA has approved the medicine nerandomilast (Jascayd) to treat adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). IPF and PPF are conditions where the lung tissue becomes scarred over time and as a result breathing becomes increasingly difficult. The active ingredient, nerandomilast, helps to regulate the immune system and reduces tissue scarring on the lungs. The recommended dose is an 18mg tablet taken orally twice a day. Nerandomilast provides a new treatment option for adults with PF and PPF.
The new marketing authorisation was granted to Boehringer Ingelheim Limited International GmbH.
MHRA approves world's first lower-carbon beclometasone inhalers
MHRA has (as of 21 July 2026) approved new versions of Clenil# Modulite 100 micrograms inhaler and Clenil Modulite 200 micrograms inhaler, containing beclomethasone dipropionate for the maintenance treatment of asthma in adults and children.
The approval marks the world’s first authorisation of pressurised metered-dose inhalers (pMDI) using the next-generation propellant HFA-152a. The propellant itself is not an active medicine but is used to deliver the inhaled dose. These new versions will be available in the UK later in 2026.
The variation to the existing marketing authorisation was granted on 21 July 2026 to Chiesi Limited.
Conferences / webinars / workshops etc.
EDQM Workshop on quality management for tissues and cells
EDQM is launching a new training session to promote sharing of knowledge, skills and best practices among professionals across Europe – a two-day, in-person workshop focusing on qualification, validation and verification for SoHO establishments handling tissues, cells, and other related SoHO (such as human milk or intestinal microbiota) from 16 to 17 November 2026. This training is co-funded by the EDQM and the EU commission.
This is an exceptional opportunity to engage directly with numerous experts, many of whom were involved in the elaboration of the upcoming Guide to the quality and safety of tissues and cells for human application (6th edition). The application phase closed on Sunday, 19 July 2026 and all applicants were to be notified about the status of their application by 31 July 2026.
And finally…
We hope that our readers find our reviews to be both informative and helpful in keeping up to date with pharmaceutical legislation and regulatory guidance.
Further information on these and other topics can be found in recent versions of the “Regulatory Update” on the PHSS website (members area) by utilising the hyperlink within that particular Update.
GMP Update is compiled by Malcolm Holmes C.Chem. MRSC, a member of the PHSS Management Committee.
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