- lauraclark849
- Apr 4
- 11 min read
Review of Developments in GMP and the Regulation of Medicines March 2025
EJPPS vol 30.1C
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 and, EU, regulatory authorities.
The topics covered in this edition of the “Update” include:
UK
Medicines and Healthcare products Regulatory Agency (MHRA)
· MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapies
· Digital mental health technologies guidance launched to help manufacturers and safeguard users
· Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework
· Advanced therapy medicinal products: regulation and licensing in UK
· Licensing plasma master files and vaccine antigen master files
· Guidance on the licensing of biosimilar products
EU
European Medicines Agency (EMA)
· Establishment of regular procedure for scientific advice on certain high-risk medical devices
· GMP - Regulatory expectations and certificates following COVID-19 public health emergency
· Q&A for biological medicinal products
· Certificates Processing System: Demo & Q&A session for industry stakeholders
· Leqembi EMA response
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
· Strengthening European SoHO systems
· EDQM and COVID-19 – Rising to the challenge of a global crisis
· Online publication on study for establishment of new Golimumab BRP
· Online publication of study for establishment of Ph. Eur. Human anti-D immunoglobulin BRP batch 2
Ireland
The Health Products Regulatory Authority (HPRA)
· Certificate of free sale for medical devices process updates
USA
The US Food and Drug Administration (USFDA)
· Post election status
Products
· IXCHIQ vaccine approved to protect adults against Chikungunya
· Medical imaging agent gozetotide approved for diagnosis of prostate cancer
· Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients in the UK
· mRESVIA RSV vaccine approved to protect patients aged 60 and over
Conferences
· PHSS Aseptic Processing Workshop
RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS
UK
Medicines and Healthcare products Regulatory Agency (MHRA)
MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapies
The draft MHRA guidance aims to clarify and streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles
This consultation is for individualised mRNA cancer immunotherapies (colloquially referred to as cancer vaccines). This is an important step in bringing these promising therapies closer to clinical practice.
The eight-week consultation will run until 31 March 2025. The MHRA is asking all stakeholders, including developers of these medicines, to provide comments, after which the guidance will be updated. The UK regulator also welcomes comments from members of the public including people affected by cancer.
The guidance aims to streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles.
Digital mental health technologies guidance launched to help manufacturers and safeguard users
The MHRA has issued new guidance to help manufacturers navigate and meet UK medical devices regulations and ensure digital mental health technologies are effective, reliable and acceptably safe and protect users of digital mental health technologies.
From mental health apps, AI-powered assessments, and virtual reality therapy, digital mental health technologies are increasingly used by individuals and the NHS to support mental health.
Digital mental health technologies that diagnose, prevent, or treat conditions using complex software must meet medical device standards to ensure they are effective and acceptably safe, just like any other medical device. Manufacturers may be unsure how medical devices regulations apply to software, which products are regulated, how they are assessed, and what evidence is required.
This new guidance explains:
· How to define and communicate the intended purpose of a digital mental health technology
· When a digital mental health technology is considered a medical device under UK law.
· How risk classification is determined, ensuring proportionate regulation for different types of technologies.
Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework
This document was updated on 20 Feb. 2025
This guidance is to support manufacturers and wholesale dealers authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) and the associated qualified persons (QPs), responsible persons (RPs) and responsible persons for Import (RPis) in order to implement the arrangements of the Windsor Framework for human medicines.
Marketing authorisation holders (MAH) will need to ensure changes are communicated to the manufacturer in a timeframe which will enable the manufacturer to ensure that all batches it produces have the correct labelling and product information.
The Windsor Framework sets out the long-term arrangements for the supply of medicines into Northern Ireland. It will ensure that human medicines can be approved and licensed on a UK-wide basis by the MHRA and provides for the disapplication of European Union (EU) Falsified Medicines Directive (FMD) safety features for medicines marketed and supplied in Northern Ireland.
Advanced therapy medicinal products: regulation and licensing in UK
This guidance covers how to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
This guidance was updated on 27 Feb. 2025, with information on changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Licensing plasma master files and vaccine antigen master files
This guidance, issued 27 Feb 2025, covers processes for applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
Guidance on the licensing of biosimilar products
Guidelines (updated 27 Feb. 2025-with added links to guidance on licensing advanced therapy medicinal products and plasma master files and vaccine antigen master files) to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
Europe
European Medicines Agency (EMA)
Establishment of regular procedure for scientific advice on certain high-risk medical devices
EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical investigation.
Manufacturers of class III devices and class IIb active devices intended to administer or remove medicines can now submit their request for advice via a portal and consult the medical device expert panels at different stages of the clinical development.
Advice given by the medical device expert panels is a key tool to foster innovation and promote faster patient access to safer and more effective devices.
GMP - Regulatory expectations and certificates following COVID-19 public health emergency
EMA, the European Commission and the Heads of Medicines Agencies (HMA) have phased out the extraordinary regulatory flexibilities for medicines that applied during the COVID-19 pandemic. The GMP / GDP Inspectors Working Group extended the validity of GMP certificates as a temporary regulatory flexibility in 2021. The working group prolonged this extension until the end of 2024. From 2025, this extension no longer applies.
The working group took into account that national competent authorities (NCAs) had resumed regular on-site inspections. It also considered that NCAs are using other methods to gather compliance information, such as distant assessments and inspections that international partners carry out. These methods enabled decisions on certificate validity. They also helped reduce inspection backlogs, which are expected to be resolved in 2025.
NCAs will decide on a case-by-case basis whether any additional extension to a GMP certificate is needed.
Q&A for biological medicinal products
· The following sections have been updated
· Low Endotoxin Recovery, Endotoxin masking effect (3.2.P.5.3)
· Excipient, Composition (3.2.P.1)
· Container closure system (3.2.P.7)
· Prior knowledge
Certificates Processing System: Demo & Q&A session for industry stakeholders
From 1 January 2025, EMA certificates of medicinal product must be ordered through the Certificates Processing System.
The EMA invites all human and veterinary industry stakeholders to an on-line system demonstration session followed by a Q&A on the Certificates Processing System. 13 March 2025, 11:30 - 12:00 Greenwich Mean Time (GMT)
Leqembi EMA response
Leqembi, intended for the treatment of early Alzheimer’s disease in apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes. The applicant for this medicinal product is Eisai GmbH.
As part of its decision-making process, the European Commission asked the CHMP to consider information on the safety of Leqembi that became available after the adoption of the CHMP opinion in November 2024 and whether this would require an update of the opinion. The Commission also asked the CHMP to consider whether the wording of the risk minimisation measures in Annex II of the opinion was clear enough to ensure correct implementation.
The CHMP has now considered this request and concluded that its November opinion recommending the marketing authorisation of Leqembi does not need to be updated. EMA has provided a response to the European Commission which will now resume the decision-making process for Leqembi’s marketing authorisation
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
Strengthening European SoHO systems
EDQM and the European Union (EU) have just signed a new agreement aimed at further enhancing substances of human origin (SoHO) systems and strengthening their capacity across Europe and beyond.
Through this agreement – which covers the triennium 2025 to 2027 – both organisations reaffirm the importance of making the best use of their respective strengths and resources and ensuring that these vital medical resources remain safe, of high-quality and available to those who need them, while protecting both recipients and donors.
Through this agreement, the EU expresses its support to the EDQM in its new role by co-financing the development of standards to be included in the guides and their digitalisation. The agreement also covers other activities aimed at helping member states and SoHO entities to implement the standards, including the development of action plans to ensure a sustainable supply of blood, tissues, cells and organs in Europe, and the extension of data harmonisation and quality activities such as proficiency testing schemes, training programmes and assessments of SoHO establishments.
EDQM and COVID-19 – Rising to the challenge of a global crisis
In this EDQM on air podcast EDQM explains how :-
Protecting public health during a pandemic requires not only preparedness, with robust systems and co-operation networks in place, but also technical and procedural innovation and unwavering dedication among all healthcare professionals. The pandemic highlighted just how important the EDQM’s mission is to ensure high standards in public health protection. Due to the resourcefulness of its staff and its extensive networks of experts, partners and stakeholders, the EDQM played a crucial role in the fight against COVID-19 In this episode, Catherine Milne, Gwenaël Cirefice and Pierre Leveau from the EDQM explain how.
[This is a 25 minute listen – though you can speed up the delivery if you wish – Going back over Covid-19 is not particularly enjoyable- but it is worth listening to the EDQM podcast to hear their take on some of the issues and lessons learned. MBH]
Online publication on study for establishment of new Golimumab BRP
The outcome of a successful Biological Standardisation Programme study (BSP164) for the establishment of a new European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for golimumab, a fully human therapeutic TNF targeting monoclonal antibody, has been published.
Online publication of study for establishment of Ph. Eur. Human anti-D immunoglobulin BRP batch 2
The EDQM’s Biological Standardisation Programme, a joint programme of the Council of Europe and the European Commission, has recently run a study to establish batch 2 of the European Pharmacopoeia (Ph. Eur.) Human anti-D immunoglobulin Biological Reference Preparation (BRP). The batch was adopted by the European Pharmacopoeia Commission in October 2024 and will be available for purchase once stocks of batch 1 are depleted.
Ireland
The Health Products Regulatory Authority (HPRA)
Certificate of free sale for medical devices process updates
HPRA recently updated its process for applying for certificates of free sale for medical devices.
These process changes should create a more efficient process both for applicants and the HPRA. It is envisaged that these changes will also reduce errors in applications, enable quicker validation checks and improve processing times.
United States of America
The US Food and Drug Administration (USFDA)
Post election status
At this time there are no issues to report whilst the internal processes are ongoing.
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]
IXCHIQ vaccine approved to protect adults against Chikungunya
Chikungunya vaccine has been approved for use as a prophylaxis against chikungunya disease. The vaccine contains a form of the virus that has been weakened in the laboratory so it cannot multiply.
The new marketing authorisation was granted on 4 February 2025 to Valneva Austria GMBH
The vaccine has been approved by the MHRA under the International Recognition Procedure, after confirming it meets the UK regulator’s standards of safety, quality, and effectiveness.
Medical imaging agent gozetotide approved for diagnosis of prostate cancer
MHRA has approved gozetotide (brand name Illuccix) to be used in a type of medical imaging procedure called a Position Emission Tomography (PET) scan which is used to detect specific types of cancer cells in adults with prostate cancer. Gozetotide binds to the cancer cells with prostate-specific membrane antigen (PSMA) on their surface, making them visible during the PET scan.
This product was submitted and approved via a national procedure. The new marketing authorisation was granted to Telix Pharmaceuticals (UK) Limited
Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients in the UK
This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure.
MHRA has approved the medicine nemolizumab (brand name Nemluvio) for the treatment of two skins conditions – moderate to severe prurigo nodularis for adults aged 18 and above, and moderate-to-severe atopic dermatitis (eczema) for adults and adolescents aged 12 and above. Prurigo nodularis is a chronic skin condition that causes hard, itchy bumps called nodules.
Nemolizumab has also been approved for both adults and adolescent patients (from aged 12 years and with a body weight of at least 30kg) for the treatment of moderate-to-severe atopic dermatitis. It has been approved for use in combination with topical therapies used on the skin when the atopic dermatitis is not well controlled by topical therapies alone.
The new marketing authorisation was granted to Galderma (U.K.) Limited.
mRESVIA RSV vaccine approved to protect patients aged 60 and over
MHRA has approved an mRNA respiratory syncytial virus (RSV) vaccine (brand name mRESVIA) to protect patients aged 60 and over against lower respiratory tract disease caused by RSV.
This national approval is supported by evidence from a study in over 35,000 adults who were age 60 or older. In this study, participants were given either a single dose of the RSV vaccine or a placebo (dummy) injection.The study found that around 4 months after vaccination, people who received the RSV vaccine had a 79% reduction in their risk of getting lower respiratory tract disease caused by RSV, compared with those who received placebo.
The new marketing authorisation was granted on 27 February 2025 to Moderna Biotech Spain.
Conferences
PHSS Aseptic Processing Workshop
March 25–26, 2025 | Woodland Grange, Leamington Spa
The Workshop provides two days of intensive, CPD-accredited training on best practices in aseptic manufacturing and contamination control. The program includes keynote presentations and interactive, small-group workshops designed for professionals at various stages in the field of aseptic processing.
Immersive, hands-on experience in aseptic processing led by industry experts.
Enhance your understanding of GMP compliance, contamination control strategies, and environmental monitoring.
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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