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Review of Developments in GMP and the Regulation of Medicines May 2026
EJPPS Volume 31.2B
INTRODUCTION
During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the UK, EU, USA, Swiss and Australian regulatory authorities.
The topics covered in this edition of the “Update” include:
UK
Medicines and Healthcare products Regulatory Agency (MHRA)
· MHRA delivers its targets to increase access to medicines and reinforce UK position as a global destination for life sciences
· UK and US deepe
n regulatory cooperation on medical devices
· MHRA expands AI Airlock programme
· Access Consortium Promise Pilot Pathway
· Recommended use of some nasal decongestant sprays limited to five days
· MHRA and eBay working in partnership to safeguard public health
· Changes to medicines access following pharmaceutical partnership with USA
· Launch of clinical trial reforms
· Clinical investigations for medical devices
· Seven sentenced after MHRA investigation uncovers £1.8m illegal medicines and steroids network
EU
European Medicines Agency (EMA)
· Meeting with senior representatives of pharmaceutical companies
· Concept paper on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products
· New pilot to support development of ‘breakthrough’ medical devices
· Highlights – 16th Industry Standing Group (ISG) meeting
· Annexes to: ICH Q3C Guideline on impurities: guideline for residual solvents & - VICH GL18 Impurities:residual solvents in new veterinary medicinal products,active substances and excipients
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
· Guideline on requirements for revision and renewal of CEPs
· European Pharmacopoeia Issue 13.1
· Implementation of the European Pharmacopoeia Issue 13.1 – Notification for CEP holders
· EDQM publishes guidelines to promote traceability of medicines in hospital settings
· CEP holders invited to comment on draft monographs published in Pharmeuropa 38.2
· Public consultation on revised general chapter 5.1.10. Guidelines for using the test for bacterial endotoxins
· Reference Standards
· Launch of the European Drug Shortages Formulary (EDSForm) platform
Ireland
The Health Products Regulatory Authority (HPRA)
· CTCG Guidance and Webinar: New Article 11 Workaround for Clinical Trials
USA
The US Food and Drug Administration (USFDA)
· Establishing Impurity Specifications for Antibiotics
International
Australia
Therapeutic Goods Administration (TGA)
· Bacteriophages
· Therapeutic goods are not affected by the Industrial Chemicals Environmental Management Standard (IChEMS)
Switzerland
Swissmedic
· Implementation of the adjustments from the EU ADRA project
Products
· Sevabertinib approved by MHRA to treat adults with HER2-positive lung cancer that has spread or cannot be removed by surgery
· Olezarsen (Tryngolza) approved by MHRA for the treatment of familial chylomicronemia syndrome
· MHRA approves Single-dose 7.2mg semaglutide (Wegovy) pen.
· Enflonsia (clesrovimab-cfor) approved to prevent RSV in newborns and infants
· EMA recommends authorisation of first veterinary vaccine using RNA technology
Conferences / webinars etc
· EMA Webinar on reflection paper on the qualification of non-mutagenic impurities
· Webinar: EDQM explains new reliance-based and fast-track assessment pathways for CEP applications
RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS
UK
Medicines and Healthcare products Regulatory Agency (MHRA)
MHRA delivers its targets to increase access to medicines and reinforce UK position as a global destination for life sciences
MHRA met or exceeded all statutory targets to increase access to medicines and medical devices for UK patients.
The MHRA continues to speed up access to medicines for patients, increase efficiency of regulation and help to attract innovation and investment in the UK’s thriving £100 billion life sciences industry.
UK and US deepen regulatory cooperation on medical devices
The UK MHRA and the US FDA are strengthening cooperation on medical device regulation, to support faster access to safe, innovative technologies for patients in both countries.
The announcement builds on today’s wider US-UK pharmaceutical partnership, which removes tariffs on UK medicines exports and encourages companies to launch new treatments in the UK.
Closer US-UK regulatory collaboration supports the UK’s global life sciences leadership, reducing duplication for innovators while maintaining world-class safety standards.
MHRA expands AI Airlock programme
MHRA has secured a major funding uplift to expand its pioneering AI Airlock programme, the UK’s first regulatory sandbox for Artificial Intelligence as a Medical Device (AIaMD).
Following a successful second phase, the Department of Health and Social Care (DHSC) has allocated £1.2 million per year for the next three years (2026–2029) to the programme.
The newly approved multi‑year funding will enable the AI Airlock programme to scale beyond the constraints of yearly financial cycles. This will support more ambitious, longer-term testing models while helping to create a more sustainable regulatory pathway for future AI medical technologies. AI Airlock is led by the MHRA in partnership with DHSC, NHS AI Team, and Team AB (the consortium of UK Approved Bodies). The programme is a key enabler of wider AI regulatory reform.
Access Consortium Promise Pilot Pathway
The Access Consortium working group for new active substances has established an aligned process for priority review, which includes the decision on priority status. In order to facilitate the process for applicants, common timelines for the priority review request have been established, and the request is evaluated in a collaborative way, seeking a consensus decision.
Applications for new active substances fulfilling the following criteria are eligible for the Promise Pilot Pathway:
diagnoses, treats or prevents a condition that is serious, life-threatening or severely debilitating and
for which no other treatment is currently registered and marketed in participating jurisdictions for the proposed indication
The scope of the Promise Pathway will be further reviewed after the pilot.
Recommended use of some nasal decongestant sprays limited to five days
The MHRA has limited the use of nasal decongestant sprays containing xylometazoline and oxymetazoline to a maximum of five days due to side effects of prolonged use. All new packaging and leaflets inside packs of sprays and drops containing xylometazoline and oxymetazoline will state the duration of use is not to exceed five days. The wording of the leaflets will also be strengthened to emphasise the risks associated with prolonged use. Changes in product information will take some months to be implemented. Shops will continue to sell existing stock of nasal decongestants with packaging that states that they can be used for up to seven days.
MHRA and eBay working in partnership to safeguard public health
The ongoing partnership between the Medicines and Health products Regulatory Agency (MHRA) and global online marketplace eBay has removed a further 215 listings of potentially dangerous unauthorised erectile dysfunction medicines from the platform.
The shape of the tablets indicated that they were not genuine medicines and assessment by MHRA’s Borderline products team, who are responsible for the classification of products, confirmed this was the case. MHRA alerted eBay and the company immediately took action by removing the listings offering the erectile dysfunction tablets from sale to the public.
Arrangements in place between eBay and MHRA enable non-compliant medicines and medical devices to be withdrawn from the platform quickly and this helps to protect the health and safety of the UK public.
eBay has been cooperating with the MHRA for many years, enabling the Agency to provide support and advice. In 2025, a cutting-edge AI algorithm developed with eBay successfully identified and blocked more than two million violations of the company’s policies on prescription-only and non-prescription medicines, before the products could be offered for sale to the public.
Changes to medicines access following pharmaceutical partnership with USA
NHS patients will get improved access to life-changing treatments as a result of medicines pricing changes — 2 new cancer medicines already recommended under the updated approach
The UK is the first country in the world to secure commitment to 0% tariffs on pharmaceutical exports to the US
In a boost to economic growth, the UK will benefit from greater life sciences industry investment and highly skilled manufacturing jobs will be safeguarded
Thousands of NHS patients will get improved access to life-changing treatments, after the government today agreed the full text of its landmark US-UK pharmaceutical partnership. UK pharmaceutical exports to the US — worth at least £5 billion a year — will enter the United States completely tariff free, for at least 3 years. This makes the UK the first country in the world to secure 0% tariffs on pharmaceutical exports to the US.
The partnership also accelerates NHS patients’ access to new medicines.
Under the partnership, pharmaceutical companies have stronger incentives to launch innovative treatments in the UK, meaning patients can benefit from new cancer therapies, rare disease treatments, and other breakthrough medicines sooner — without waiting years after they become available elsewhere.
Launch of clinical trial reforms
Patients in the UK are to get access to new treatments faster and still safely under new clinical trial regulations coming into force on 28 April 2026.
MHRA and Health Research Authority (HRA) are introducing the largest package of reforms in over 20 years. This will include faster assessment of first in human trials and the introduction of notifiable trials, a fast-track route to allow lower-risk trials to start sooner and modification to be approved quicker, whilst maintaining the highest safety standards.
The reforms will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace new approaches, including use of early safety data from overseas studies which meets UK standards and computer model simulations which can help to predict how new medicines may behave before they are tested in patients.
The regulators have already made headway towards delivering more streamlined and efficient approvals, which has contributed to exceeding the government’s ambitious target to reduce clinical trial set-up times to 150 days as part of its 10-year plan for the NHS.
This is good news for patients and researchers, enabling new trials to be set up more quickly and improving patient care.
Innovations include the Route B substantial modification pathway which was successfully piloted from October 2025 to March 2026 and received strong support from the research community. It offers a faster, risk proportionate way to assess certain substantial modifications that do not introduce new safety concerns.
Clinical investigations for medical devices
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. You may need to carry out a clinical investigation as part of the process to obtain a UKCA, CE or CE UKNI marking for your medical device. You must inform the MHRA if you are planning to do this at least 60 days before starting your investigation.
Seven sentenced after MHRA investigation uncovers £1.8m illegal medicines and steroids network
An MHRA-led investigation has exposed a £1.8 million illegal medicines and steroids network, leading to seven men being sentenced. The group received combined sentences totalling more than 21 years’ imprisonment.
The investigation began after UK Anti-Doping (UKAD) identified website linked to the Bolton area that were suspected of selling performance-enhancing steroids and other illegal medicines.
During enforcement action, officers seized more than 130,000 doses of steroids and unauthorised medicines that were being sold by mail order. These included products such as tamoxifen, finasteride and modafinil, highlighting the scale and complexity of the illegal supply network.
Further searches across Bolton led to a number of arrests. Several individuals were charged with offences including conspiracy to supply controlled drugs, supplying unauthorised medicines, and money laundering to the value of over £1.8 million.
Europe
European Medicines Agency (EMA)
Meeting with senior representatives of pharmaceutical companies
EMA is hosting a meeting with senior representatives of pharmaceutical companies to facilitate strategic dialogue on key priority areas for the Agency and the EU Regulatory Network.
The meeting complements EMA's regular engagements with industry trade associations.
Registration is by invitation only.
Friday, 17 April 2026, All day Amsterdam
Concept paper on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products
This concept paper addresses the need for a guideline on data requirements for applications for marketing authorisations based on Article 19 of Regulation (EU) 2019/6 (“hybrid veterinary medicinal products”) for similar biological veterinary medicinal products, henceforth referred to as “biosimilars”.
The need to clarify the data requirements for hybrid applications for marketing authorisation concerning biosimilars was identified by requests for scientific advice from companies seeking guidance in this area. Therefore, guidance on the comparability approach in line with section IV.2.3 of Annex II18 to Regulation (EU) 2019/6 is needed.
The deadline for comments is 31 July 2026.
New pilot to support development of ‘breakthrough’ medical devices
The purpose of the pilot is to test a new regulatory pathway that supports patient access to highly innovative technologies, while maintaining the EU’s rigorous safety and performance standards.
As part of the pilot, manufacturers whose devices are granted ‘breakthrough’ status will benefit from enhanced regulatory support, including priority scientific advice from the medical device expert panels that are overseen by EMA.
Breakthrough designation can be granted to highly innovative medical devices that demonstrate the potential to address unmet medical needs, or that offer substantial advantages over existing technologies.
The EMA pilot will be conducted in three phases. Phase one is open to class III (high risk) medical devices and class IIb active medical devices intended to administer or remove medicines from the body. Detailed guidance and application templates for manufacturers for phase one are published on EMA’s website. Subsequent phases of the pilot will be open to other types of devices, including in vitro diagnostics (IVDs).
Highlights – 16th Industry Standing Group (ISG) meeting
The chair and the EMA Executive Director opened the meeting by welcoming members of the Industry Standing Group (ISG) and emphasising the opportunity represented by the revised pharmaceutical legislation to collectively define the future EU regulatory system focused on simplification, innovation, and digitalisation.
Annexes to: ICH Q3C Guideline on impurities: guideline for residual solvents & - VICH GL18 Impurities:residual solvents in new veterinary medicinal products,active substances and excipients
This document is open for comments until 30 June 2026.
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
Guideline on requirements for revision and renewal of CEPs
The EDQM guideline has been revised to ensure alignment with the requirements of the following applicable revised EU legislation:
· guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures;
· Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use.;
· Commission implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (veterinary products). The revised guideline also clarifies situations where revision of an existing CEP is not possible and a separate CEP application is required. A transitional implementation period of two months will apply following publication of the revised guideline.
The revised guideline will enter into full force and effect as of 1 July 2026.
European Pharmacopoeia Issue 13.1
The European Pharmacopoeia (Ph. Eur.) Issue 13.1 is now available and will be applicable in 39 European countries as of 1 January 2027.
Implementation of the European Pharmacopoeia Issue 13.1 – Notification for CEP holders
Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 January 2027.
The need to submit information to the EDQM following a revised monograph depends on the changes made to the monograph.
It remains the responsibility of the CEP holder to comply with the requirements of the monograph and if necessary to update their respective applications by the implementation date of the revised monograph at the latest, regardless of whether they have been contacted by the EDQM.
EDQM publishes guidelines to promote traceability of medicines in hospital settings
The aim of this document is to highlight the importance of hospital traceability of medicines at the point of administration, share experiences and best practices and encourage stakeholders to implement the approaches it presents and, by extension, improve patient safety.
Digitalisation prompts new ways of thinking along with changes in organisational culture, processes, roles and expertise. Given the diversity of hospital resources, healthcare systems and IT infrastructures across Europe and the significant investments required. The guidelines do not propose a single model. Instead, they present best practices and a harmonised European regulatory framework for barcoding all authorised medicines at primary packaging level, with options for phased implementation.
CEP holders invited to comment on draft monographs published in Pharmeuropa 38.2
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 38.2.
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.
Public consultation on revised general chapter 5.1.10. Guidelines for using the test for bacterial endotoxins
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter
General chapter 5.1.10 provides guidance for the use of the test for bacterial endotoxins described in general chapter 2.6.14. Bacterial endotoxins. It has been revised to add the method using recombinant factor C (rFC) and to clarify which specific provisions apply only when using amoebocyte lysate. In addition, section 11 – ‘Replacement of a method prescribed in a monograph’ – has been reinstated and now includes a new reference to the method using recombinant cascade reagents (rCRs), which may be considered as an alternative method in accordance with the General Notices. The methods using rFC and rCRs avoid the use of animal-derived reagents. Revised general chapter 5.1.10 also reflects the changes introduced in general chapter 2.6.14, which will be published in Issue 13.1 of the Ph. Eur.
The draft general chapter will remain open for public consultation until the end of June 2026. All interested parties are encouraged to review it and submit their comments.
Reference Standards
EDQM has just published its monthly newsletter on the situation of European Pharmacopoeia reference standards. It includes information on new and replacement batches, distribution quotas, the removal and future removal of reference standards, changes in sales units, amounts per unit, price and in EDQM storage and/or shipping conditions, as well as information on International Chemical Reference Substances and International Standards for Antibiotics.
Launch of the European Drug Shortages Formulary (EDSForm) platform
This launch marks a significant step forward in supporting the continuity of patient care during medicine shortages. Developed under the joint auspices of the European Committee on Pharmaceuticals and Pharmaceutical Care (CD‑P‑PH) and the European Pharmacopoeia Commission, the initiative aims at bringing together, at European level, a coherent set of monographs describing methods for the compounding that may be used when licensed alternatives are unavailable. The overarching aim of the project is to provide healthcare professionals with standardised formulations that can be prepared safely and effectively when shortages occur, thereby helping to safeguard patient access to essential treatments.
As part of this launch, three finalised texts are being published:
· the Introduction to the European Drug Shortages Formulary, presenting its purpose, scope and objectives;
· the General principles of the European Drug Shortages Formulary, setting out the background to the texts and the general rules for their interpretation;
· a monograph on Amoxicillin capsules (125 mg, 250 mg and 500 mg), supporting the preparation of a critical antibiotic in the event of shortages. already demonstrated its practical value during previous supply disruptions in France.
Ireland
The Health Products Regulatory Authority (HPRA)
CTCG Guidance and Webinar: New Article 11 Workaround for Clinical Trials
The Clinical Trials Coordination Group (CTCG) has published guidance for sponsors on a new workaround for Article 11 of the Clinical Trial Regulation (Regulation (EU) No 536/2014). This approach will apply from 27 April 2026.
The new process applies to clinical trials where Part I-only submissions are planned for some Member States Concerned (MSCs). Currently, if any MSC remains Part I only, sponsors cannot submit substantial modifications or add new MSCs in CTIS.
Under the new approach, clinical trial sponsors may submit Part II placeholder documents for these MSCs as part of the initial application. This will prevent CTIS issues and enable all MSCs to be included in any future substantial modifications to the trial.
The Webinar was held on April 15
United States of America
The US Food and Drug Administration (USFDA)
Establishing Impurity Specifications for Antibiotics
This draft guidance provides recommendations regarding the establishment of specifications for organic impurities in antibiotics manufactured by fermentation and semi-synthesis. This draft guidance applies to antibiotic drugs subject to approval under new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and associated type II drug substance drug master files (DMFs) referenced in antibiotic NDAs and ANDAs. This guidance also applies to nonprescription antibiotic drugs, often referred to as over-the-counter (OTC) monograph drugs. By providing these recommendations, FDA intends to clarify effective control strategies, support the development of high-quality antibiotic products, and promote consistency in quality standards.
Comments on the draft guidance should be submitted by 22 June 2026.
International
Australia
Therapeutic Goods Administration (TGA)
Bacteriophages
Bacteriophages are viruses that kill bacteria. In Australia, bacteriophage therapy when used in humans are regulated as a medicine
This page was last updated 28 April 2026
Manufacturers of most bacteriophage products are still required to hold a GMP licence and meet all standard regulatory requirements. However, following feedback from public consultation in late 2025, we intend to amend the legislation to allow a 3-year GMP exemption for the domestic manufacture of small batch bacteriophage therapy products used to treat an infection in a particular individual or a limited number of individuals. The exemption is expected to commence in 2026, although the exact timing is yet to be confirmed
The exemption will apply only to GMP licensing of the manufacturing site.
It will allow manufacturers to produce small batches of bacteriophage therapy products to treat a specific infection or a limited number of patients without holding a GMP licence, once the exemption is in place.
Therapeutic goods are not affected by the Industrial Chemicals Environmental Management Standard (IChEMS)
Following stakeholder queries, we are providing an updated statement on the IChEMS and the prohibitions relevant to chemicals such as certain PFAS chemicals, UV-328 and Dechlorane Plus.
IChEMS prohibits the import, manufacture and use of specified chemicals in Australia and support Australia’s obligations under the Stockholm Convention on Persistent Organic Pollutants. However, IChEMS does not apply to chemicals used for therapeutic purposes.
We do not regulate environmental safety and cannot grant exemptions to IChEMS prohibitions, but we encourage manufacturers to reduce the use of IChEMS listed chemicals in medical devices, medicines and biologicals over time. We also encourage sponsors to contact us if they become aware of a potential impact on patients due to a disruption to supply of a medical device, medicine or biological because of the IChEMS prohibitions.
Switzerland
Swissmedic
Implementation of the adjustments from the EU ADRA project
Launched in the EU, the ADRA project aims to adjust the dosage regimens and withdrawal periods of antibiotics with older authorisations without clinical studies. Swissmedic intends to adopt the results of the project for the relevant veterinary medicinal products authorised in Switzerland as soon as specific recommendations are communicated by the EMA.
Products
Sevabertinib approved by MHRA to treat adults with HER2-positive lung cancer that has spread or cannot be removed by surgery
Sevabertinib is a protein kinase inhibitor that works by blocking abnormal HER2 protein which drives the growth of cancer cells. By targeting this protein, the medicine can help to slow or stop the cancer from growing and, in some cases, shrink the tumour. Clinical trial evidence shows sevabertinib produced positive responses in 71% of previously treated patients with advanced HER2 mutations, with many positive responses lasting six months or longer. Sevabertinib has been approved through Project Orbis, a global partnership between the MHRA, the Therapeutics Goods Administration in Australia, Health Canada, the Health Sciences Authority in Singapore, Swissmedic, Agência Nacional de Vigilância Sanitária in Brazil and Israel’s Ministry of Health, coordinated by the US Food and Drug Administration. This programme reviews and approves promising cancer drugs, helping patients to access treatments more quickly.
Olezarsen (Tryngolza) approved by MHRA for the treatment of familial chylomicronemia syndrome
MHRA has approved olezarsen (Tryngolza) to help treat adults with familial chylomicronemia syndrome (FCS). FCS is an inherited disease that gives rise to abnormally high levels of fats called triglycerides in the blood. This can lead to inflammation of the pancreas, causing severe pain, lasting damage to the pancreas, and can be life threatening. Olezarsen is administered as an injection under the skin,
In a main study involving 66 adults with FCS, olezarsen was shown to significantly reduce triglyceride levels in the blood. All patients followed a controlled diet and received either Tryngolza or a placebo.
The approval was granted to Swedish Orphan Biovitrum AB (publ)
This product was submitted and approved via International Recognition Procedure (IRP) Route B
MHRA approves Single-dose 7.2mg semaglutide (Wegovy) pen.
MHRA has approved the new single-dose 7.2mg semaglutide (Wegovy) pen to treat adult patients with obesity, who have a Body Mass Index (BMI) of 30kg/m² or higher.
Today’s approval will support adult patients with obesity by providing the option of a single-dose injection to receive the maximum weekly dose for weight loss and weight management.
The 7.2mg dose is administered via one injection.
This decision follows the January 2026 approval of the 7.2mg maximum weekly dose, which required three 2.4mg doses administered on the same day using the standard 2.4mg pen.
Enflonsia (clesrovimab-cfor) approved to prevent RSV in newborns and infants
MHRA has approved the medicine Enflonsia (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants up to 12 months of age throughout their first RSV season.
The active ingredient in Enflonsia, clesrovimab, is an antibody that helps prevent lung disease caused by RSV.
The new marketing authorisation was granted to Merck Sharp Dohme (UK) Limited.
EMA recommends authorisation of first veterinary vaccine using RNA technology
EMA has recommended granting a marketing authorisation in the EU for Nobivac NXT HCPChFeLV, a vaccine for protecting cats against common infectious diseases.
The vaccine targets five pathogens. Nobivac NXT HCPChFeLV is the first veterinary vaccine recommended for authorisation in the EU that contains self‑amplifying RNA as an active substance.
Conferences /webinars etc
EMA Webinar on reflection paper on the qualification of non-mutagenic impurities
EMA has published a reflection paper on the qualification of non-mutagenic impurities.
The current version follows the earlier one that was published in 2018 and has been updated considerably. The update focuses on alternative strategies for qualifying novel impurities or qualifying higher levels of impurities that were previously qualified at a lower level.
The aim of the reflection paper is to provide a practical reference for applicants regarding the qualification of novel impurities:
· arising from changed manufacturing processes;
· discovered after safety studies have been concluded;
· when higher levels need to be qualified and existing data from safety studies are not sufficient for qualification.
Wednesday, 06 May 2026 , 09:00 - 10:30 British Summer Time (GMT+1) (online)
Webinar: EDQM explains new reliance-based and fast-track assessment pathways for CEP applications
This free live webinar to be held 11 May 2026 (10:00 to 11:30 CEST, Paris, France). Places are limited, so, register today to secure a spot!
The 90‑minute session will guide CEP applicants and holders through the EDQM’s new formal pathways for requesting reliance-based and fast-track assessment of dossiers. The webinar will also explain the eligibility criteria for these assessments and the regulatory conditions under which they can be requested.
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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