- lauraclark849
- Oct 8
- 18 min read
Updated: Oct 9
Review of Developments in GMP and the Regulation of Medicines August 2025
EJPPS vol 30.3B
This month reported issues have come from the UK, EU, USA Australian & PIC/s regulatory authorities.
The topics covered in this edition of the “Update” include:
UK
Medicines and Healthcare products Regulatory Agency (MHRA)
· Government to align with European specifications on high risk in vitro diagnostic devices to reduce regulatory burden.
· Guidance on the use of real-world data in clinical studies to support regulatory decisions
· Cutting-edge personalised treatments, made while you wait, will deliver specialised care to patients more quickly
· 2024–25 Annual Report and Accounts and Impact Report
EU
European Commission- DG for Health & Food safety
Revision of GMP Guidelines Chapter 4 (Documentation), Annex 11 (Computerised Systems) and New Annex 22 (Artificial Intelligence)
European Medicines Agency (EMA)
· Strengthening supply chain of anti-D immunoglobulins
· First reformulation of an inhaled medicine with environmentally friendly gas propellant
· ICH M13B comments
· Stakeholder platform on the operation of the centralised procedure for human medicines
· Nitrosamine impurities in human medicines
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
· Pharmeuropa 37.3
· Reference standards monthly newsletter – June 2025
· Certification monthly report of activities
· Tips to improve the quality of your dossier and get a CEP faster
· Pharmacopeial Discussion Group (PDG) announces outcome of 2025 expansion round
· Public consultation on a new monograph on Adalimumab concentrated solution in Pharmeuropa 37.3
· Implementation of the 12th Edition of the Ph. Eur – Notification for CEP holders
· EPC adopts three revised texts related to pharmaceutical waters
· New general chapter 2.5.46. Phenolic antioxidants in plastic materials
· Revised general chapter 3.2.1. Glass containers for pharmaceutical use.
· NANO Working Party - publication of its first monograph, Iron Sucrose concentrated solution
· Lorazepam 1 mg/mL oral solution monograph in public consultation
· Pilot phase on monoclonal antibodies, setting the stage for future standardisation
United States of America
The US Food and Drug Administration (USFDA)
· Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations
· Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
International
Australia
Therapeutic Goods Administration (TGA).
· TGA AI Review: Outcomes report published
Pharmaceutical Inspection Co-operation Scheme PIC/s
· Revision of GMP Guidelines Chapter 4 (Documentation), Annex 11 (Computerised Systems) and New Annex 22 (Artificial Intelligence)
Products
· MHRA approves nogapendekin alfa inbakicept to treat adult patients with non-muscle invasive bladder cancer
· MHRA approves Elinzanetant to treat moderate to severe vasomotor symptoms ()
· MHRA approves sebetralstat (Ekterly) to treat hereditary angioedema (HAE) attacks
· MHRA- Tofersen approved to treat rare inherited form of motor neurone disease
· MHRA- Mirvetuximab soravtansine approved to treat adult patients who have ovarian, fallopian tube or primary peritoneal cancer
· MHRA approves adrenaline nasal spray - the first needle-free emergency treatment for anaphylaxis in the UK
· EMA/Global - New injection for easier prevention of HIV infection
Conferences, webinars etc.
· Workshop on a tailored clinical approach in biosimilar development
· PHSS Annual Conference
· PHSS - QP Forum Conference 2025
RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS
UK
Medicines and Healthcare products Regulatory Agency (MHRA)
Government to align with European specifications on high risk in vitro diagnostic devices to reduce regulatory burden.
The UK Government has announced its intention to amend the Medical Devices Regulations 2002 for Great Britain to incorporate EU Common Specifications for high-risk in vitro diagnostic (IVD) devices and to repeal regulations on Coronavirus Test Device Approvals (CTDA).
The Common Specifications will also enhance performance standards for IVD devices related to infectious diseases including Hepatitis B, C and D, HIV and Syphilis, as well as devices for blood grouping and tissue typing. These diagnostic tools are critical for effective patient care and public health management.
The move aims to ensure these vital IVD devices, which test samples from the human body to monitor health or manage disease, meet high standards of performance backed by robust clinical evidence.
Guidance on the use of real-world data in clinical studies to support regulatory decisions
The MHRA is producing a guidance series to provide general points to consider for sponsors planning to conduct clinical research using real-world data (RWD) to support regulatory decision making.
The guidance provides information to aid the design of studies aiming to provide evidence suitable for supporting regulatory decisions. This guidance is applicable to studies regardless of geographical location.
Two guidance documents have been published and a third draft guideline on the use of External Control Arms Based on Real-World Data is now open for consultation.
Cutting-edge personalised treatments, made while you wait, will deliver specialised care to patients more quickly
Patients will receive faster access to life-saving, personalised treatments made at their hospital, clinic or near their homes instead of waiting weeks for therapies manufactured hundreds of miles away, under new UK legislation that came into force on 23 July.
This world first regulation, introduced by MHRA allows breakthrough personalised medicines to be prepared in small or individual batches – bringing care closer to the patient. The change will cut waiting times where every hour counts, help free up NHS beds, and improve access to innovative therapies that were previously out of reach.
2024–25 Annual Report and Accounts and Impact Report
The MHRA 2024–25 Annual Report and Accounts, and accompanying Impact Report, demonstrates how MHRA have enhanced patient safety across the UK, restored its performance to ensure it is meeting regulatory timelines, and sharing its success in enabling access to life-changing medical products.
Europe
European Commission- DG for Health & Food safety
Revision of GMP Guidelines Chapter 4 (Documentation), Annex 11 (Computerised Systems) and New Annex 22 (Artificial Intelligence)
In light of the rapid advancement of digital technologies and the implementation of AI systems in pharmaceutical manufacturing, the update of GMP guidelines is essential to ensure that they continue to provide clear, practical and relevant guidance for manufacturers and national competent authorities.
The revision of GMP Annex 11 and Chapter 4, along with the introduction of a dedicated Annex 22 on Artificial Intelligence aim at supporting innovation in the manufacturing of medicines and ensuring regulatory harmonisation.
To maintain the global alignment of standards, achieving at the same time assurance for the highest quality, these 3 documents have been drafted by the EMA GMDP-Inspectors Working Group in cooperation with the PIC/S.
The revised Chapter 4 incorporates changes which highlight the importance of documentation in GMP compliance and support the use of new technologies, hybrid solutions, and new services in the management of documentation. The revised Annex 11 establishes enhanced requirements for the lifecycle management of computerised systems, mandating that Quality Risk Management principles be comprehensively applied during all steps. The new annex on Artificial Intelligence establishes requirements for the use of AI and machine learning in the manufacturing of active substances and medicinal products. It sets up requirements for the selection, training, and validation of AI models.
The documents are open to comments from designated organisations until 7 October 2025
European Medicines Agency (EMA)
Strengthening supply chain of anti-D immunoglobulins
EMA and the Heads of Medicines Agencies (HMA) have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.
These medicines are currently the only available treatment for the prevention of RhD immunisation during pregnancy. RhD immunisation happens when a pregnant person with RhD-negative blood type is exposed to RhD-positive blood from their foetus. This can lead to an immune reaction that can seriously impact the health of the foetus, and later of the newborn, and have potentially fatal outcomes.
Plasma, collected from donors and containing the anti-D immunoglobulin is currently the only source for manufacturing these medicines. The numbers of donors are declining, and anti-D immunoglobulins are only produced in a limited number of countries, all located outside the European Union (EU). For this reason, the MSSG has been monitoring the supply chain of these medicines and has issued these recommendations to national regulators, the European Commission, as well as to the plasma industry and relevant research organisations, to support actions to strengthen their availability and prevent serious shortages.
First reformulation of an inhaled medicine with environmentally friendly gas propellant
EMA has recommended a change in the composition of Trixeo Aerosphere and its duplicate product Riltrava Aerosphere to replace the existing gas propellant with a low global warming potential (GWP) gas alternative. The new low GWP alternative propellant has a 1000-fold reduction in global warming potential and similar physical properties compared to the current propellant.
Trixeo Aerosphere and Riltrava Aerosphere are the first inhaled medicines in the EU that have a gas propellant with low GWP. They are used for maintenance treatment in a subset of adults with moderate-to-severe chronic obstructive pulmonary disease (COPD) and are administered as two inhalations twice daily using a metered dose inhaler (MDI). High GWP gases, including hydrofluorocarbon gases such as the propellants used in pressurised MDIs treating respiratory diseases, are being phased out for environmental reasons
ICH M13B comments
Overview of comments received on ICH M13B Guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver
Stakeholder platform on the operation of the centralised procedure for human medicines
This ‘Highlights’ report summarises the 14th EMA-Industry stakeholder centralised platform meeting.
These meetings are set up by the Agency as an exchange platform between regulators and representatives of industry stakeholder organisations aiming to foster a constructive exchange on general updates and more focused discussions on specific EMA centralised processes and issues to support continuous improvement.
Nitrosamine impurities in human medicines
This report provides an overview of the response of the European Medicines Regulatory Network (EMRN) to the presence of nitrosamine impurities in human medicines.
In terms of future developments to the regulatory framework, the latest scientific knowledge on toxicology, safety and quality aspects of nitrosamines will be reflected in an addendum to the ICH M7 guideline on the assessment and control of mutagenic impurities in order to harmonise guidance on nitrosamines across ICH members, which was initiated in June 2024.
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
Pharmeuropa 37.3
54 new Ph. Eur. texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments is 30 September 2025.
Users and interested parties are welcome to comment on these drafts. It is extremely important that users provide feedback on such drafts.
Comments made after adoption of the text and/or publication in the Ph. Eur. will be too late to be considered. Users may then be in a position where their product is not compliant with the Ph. Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product can no longer be marketed in Europe.
Certification monthly report of activities:
The latest monthly activity (end of June 2025) report for the Certification of Substances Department (DCEP) is now available
Tips to improve the quality of your dossier and get a CEP faster
As an applicant using the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure, you play a central role in ensuring the smooth processing of your request. One of the best ways to accelerate the process is by improving the quality of your submission. Incomplete or inconsistent dossiers often lead to blocking issues or requests for additional information, which can significantly delay the outcome.
To help facilitate your CEP application and assist you in preparing a high-quality dossier, the EDQM provides a range of guidance documents and tools.
Reference standards monthly newsletter – June 2025
1 new Ph. Eur. And 14 replacement reference standards batches released.
Pharmacopeial Discussion Group (PDG) announces outcome of 2025 expansion round
The initial expansion phase launched in 2022 led, after a successful pilot phase, to the inclusion of the Indian Pharmacopoeia Commission as the first new member of the PDG in 2023.
The PDG carefully reviewed its available resources in light of its strategic priorities, deciding to admit one pharmacopoeia during this second phase. The group has subsequently announced that the Korean Pharmacopoeia has been selected for admission as a Candidate Participant.
Public consultation on a new monograph on Adalimumab concentrated solution in Pharmeuropa 37.3
Ph. Eur. has published a new draft monograph, Adalimumab concentrated solution (3147), for public comment in this quarter’s issue of Pharmeuropa (37.3).
Adalimumab is a widely used therapeutic human IgG1 kappa monoclonal antibody. It targets tumour necrosis factor alpha (TNF-α) – a key mediator in inflammatory responses – and is used to treat conditions such as rheumatoid arthritis and psoriasis.
Given its therapeutic importance and the numerous biosimilars available across Ph. Eur. member states, the European Pharmacopoeia Commission (EPC) decided to elaborate an adalimumab monograph using the multi-source approach. This ensures that the resulting standard can be applied by manufacturers of both originator and biosimilar products.
Implementation of the 12th Edition of the Ph. Eur – 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 2026.
The need to submit information to the EDQM following a monograph revision depends on the changes made to the monograph. Updates to the monographs are classified by the EDQM into two categories, labelled “Case A” and “Case B”, and this influences the information required. In the list of revised monographs, it is indicated which classification (“Case A” or “Case B”) is applicable. In addition to this web announcement, the EDQM, as a courtesy, will contact CEP holders with details of how to proceed for the dossiers impacted by the revised monograph(s).
EPC adopts three revised texts related to pharmaceutical waters
The European Pharmacopoeia Commission (EPC) adopted three revised texts related to pharmaceutical waters during its 182nd session in June 2025. This constitutes a significant step forward in converging quality standards for the most widely used excipients in the pharmaceutical industry. The revised texts are:
Water for Injections (0169);
Water, purified (0008);
Total organic carbon in water for pharmaceutical use (2.2.44).
These revisions, initially published for public consultation in Pharmeuropa 36.3, reflect the EPC’s commitment to modernising analytical methods. The most notable change is in the monograph on Water for injections, where the conventional test for oxidisable substances was replaced with the more sensitive and non-selective total organic carbon (TOC) test in the section on “Sterilised water for injections”. This shift enhances the detection of organic impurities and supports a more robust quality control framework.
In general chapter 2.2.44, the reagents sucrose R and 1,4-benzoquinone R were replaced with chemical reference substances (CRSs) to streamline the application of the TOC test.
The revised texts will be published in Issue 12.3 of the Ph. Eur. in January 2026 and will enter into force on 1 July 2026.
New general chapter 2.6.42. Test for procoagulant activity in immunoglobulin preparations
Ph. Eur. has published this draft of a new general chapter, for public consultation. Stakeholders are invited to submit their comments by the end of September 2025.
This new chapter has also been referenced in two revised monographs which are likewise open for comment
New general chapter 2.5.46. Phenolic antioxidants in plastic materials
The experts of Group 16 (Plastic materials, plastic containers and closures), have developed a new HPLC-UV analytical procedure to test for phenolic antioxidants in plastic materials and is described in the new general chapter 2.5.46. Phenolic antioxidants in plastic materials.
The aim of this new, fully validated analytical procedure, which covers seven different plastic additives, is to simplify the testing of phenolic antioxidants in plastic materials using state-of-the-art liquid chromatography. This single procedure given in the new general chapter is referenced in general chapters covering four plastic materials (published in the same issue of Pharmeuropa), replacing the two different existing analytical procedures (A and B) for phenolic antioxidants:
Revised general chapter 3.2.1. Glass containers for pharmaceutical use.
The experts of the Glass (GLS) Working Party, have undertaken the first significant revision of general chapter 3.2.1 since 2019, when it was published.
The primary aim of this revision is to clarify the purpose of tests A, B and C used to define the glass type and characterise its hydrolytic resistance, in response to multiple questions received from users concerning this part of the text. Additional details on each test and its purpose have therefore been incorporated and the presentation of the information has been changed.
The second key update in this general chapter is the modernisation of the spectral transmission test for coloured glass containers. As the light protection or light transmission of a coloured glass depends on the wall thickness of the containers, it was decided to modify the approach used to determine the maximum transmission. As a result, the determination and corresponding specifications are now based on the wall thickness instead of the volume and closure system of the containers.
NANO Working Party - publication of its first monograph, Iron Sucrose concentrated solution
This is a major step forward for the group established in 2023 after the European Pharmacopoeia Commission agreed to intensify the work on standards for nanomedicines.
Iron sucrose is a complex nanomedicine used in the treatment of iron deficiency. Its characterisation poses unique analytical challenges, and the proposed new monograph reflects this complexity by introducing analytical techniques described for the first time in the Ph. Eur., such as particle size distribution by dynamic light scattering or reduction potential by polarography. The inclusion of such techniques represents a forward-looking approach to ensuring the quality and safety of nanomedicine products.
Lorazepam 1 mg/mL oral solution monograph in public consultation
The 12th monograph of the PaedF Working Party, Lorazepam 1 mg/mL oral solution, has been published for public consultation. The deadline for comments is 30 September 2025.
Lorazepam, a benzodiazepine derivative, can be used in paediatric populations for the treatment of anxiety and as a premedication for anaesthesia. Although the need for age-appropriate formulations of this medicinal product was highlighted by the European Medicines Agency (EMA) in 2013, no licensed age-appropriate products are currently available.
Based on an existing unlicensed extemporaneous preparation developed in the Netherlands, this formulation is supported by validated test methods and stability data provided by the Erasmus Medical Centre in Rotterdam and by the Laboratory of the Dutch Pharmacists (LNA).
Pilot phase on monoclonal antibodies, setting the stage for future standardisation
The European Pharmacopoeia Commission (EPC) formally endorsed the conclusion of the pilot phase on monoclonal antibodies (mAbs) during its 182nd session, marking a major milestone in the development of public standards for these complex biotherapeutics.
Robust and continuous stakeholder engagement played a pivotal role in the success of the pilot phase. The results of a comprehensive survey conducted in 2024 confirmed strong support for the Ph. Eur. approach, highlighting the importance of continued collaboration.
With the conclusion of the pilot phase, the MAB WP will continue its work as a regular Ph. Eur. group. It will support the development of public standards for multi-source mAbs
The US Food and Drug Administration (USFDA)
Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations
This draft guidance is intended to clarify the key factors in calculating the aluminum content to ensure that the total aluminum exposure in parenteral nutrition (PN) does not exceed an acceptable threshold. It also provides FDA’s recommendations regarding the aluminum concentration limits for small volume parenterals (SVPs) packaged as single doses or SVPs packaged in pharmacy bulk packages (PBPs). Additionally, this draft guidance is intended to assist sponsors and applicants in determining the appropriate placement of information on aluminum toxicity in SVP and large volume parenteral (LVP) Prescribing Information and container and carton labeling. This draft guidance revises and replaces the draft guidance for industry of the same name published on December 7, 2022.
Comments are due by 2 Sept 2025
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
This final guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This final guidance for industry revises and replaces the draft guidance of the same name issued in August 2023.
International
Australia
Therapeutic Goods Administration (TGA).
TGA AI Review: Outcomes report published
This consultation aimed to identify areas for improvement in the TGA legislative framework to mitigate future risks and leverage opportunities associated with the use of AI within the therapeutic goods sector, including software as a medical device.
Government approval has been given to undertake further work in response to the 14 key findings of the report.
Pharmaceutical Inspection Co-operation Scheme PIC/s
Revision of GMP Guidelines Chapter 4 (Documentation), Annex 11 (Computerised Systems) and New Annex 22 (Artificial Intelligence)
For further detail see also the European Commission- DG for Health & Food safety section of this report
Products
[This section makes reference to some of the most notable new products approved during the past month and focuses on approvals of medicines for which there is a previously unmet need and / or where approvals have been made using shared information from other trusted regulators.MBH]
MHRA approves nogapendekin alfa inbakicept to treat adult patients with non-muscle invasive bladder cancer
MHRA has approved nogapendekin alfa inbakicept (Anktiva) for adults with BCG-unresponsive non-muscle invasive bladder cancer, where the disease remains confined to the inner lining of the bladder and may include tumours.
BCG (Bacillus Calmette-Guérin) is a standard immunotherapy for early-stage bladder cancer, delivered directly into the bladder to stimulate an immune response. However, some patients do not respond to BCG, leaving limited treatment options.
Anktiva medicine has been approved through the International Recognition Procedure (IRP). The IRP allows the MHRA to consider the expertise and decision-making of trusted regulatory partners for the benefit of UK patients. The approval was granted to Serum Life Science Europe GmbH.
Elinzanetant to treat moderate to severe vasomotor symptoms
MHRA is the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.
When oestrogen levels drop during menopause, certain brain cells become overactive and interrupt the body’s ability to control temperature, which leads to hot flushes and night sweats.
Elinzanetant is a new non-hormonal medication which works by calming these signals in the brain, helping bring the body’s temperature control back into balance.
Elinzanetant’s approval is based on results from the OASIS clinical trials, which involved over 1,400 women aged 40 to 65 across several countries. The new marketing authorisation was granted to Bayer plc. This national approval was granted after an Access Consortium new active substance work sharing initiative (NASWSI) procedure.
MHRA approves sebetralstat (Ekterly) to treat hereditary angioedema (HAE) attacks
Sebetralstat (Ekterly) for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older.
Sebetralstat is the first and only MHRA-approved oral, on-demand treatment for HAE. It is taken as soon as symptoms begin, giving patients the ability to treat the attacks as soon as they start, wherever they are, without the need for injections.
HAE is a rare genetic condition that can cause sudden and painful swelling in various parts of the body, including the face, throat, abdomen, and limbs. Attacks can be unpredictable and, in some cases, life-threatening if they affect the airways.
Sebetralstat’s approval is supported by the KONFIDENT clinical trial, in which 110 patients experienced and treated 264 hereditary angioedema attacks.
The new marketing authorisation was granted on 15 July to KalVista Pharmaceuticals Ltd.
MHRA- Tofersen approved to treat rare inherited form of motor neurone disease
MHRA approved tofersen (Qalsody) to treat adults with amyotrophic lateral sclerosis (ALS) caused by mutations in the SOD1 gene – a rare, inherited form of motor neurone disease (MND).
ALS is a progressive condition that affects nerve cells in the brain and spinal cord. This leads to muscle weakness, including the muscles needed to breathe and swallow.
The MHRA approval was granted via the International Recognition Procedure (IRP) to Biogen Netherlands B.V.
MHRA- Mirvetuximab soravtansine approved to treat adult patients who have ovarian, fallopian tube or primary peritoneal cancer
MHRA has approved the medicine mirvetuximab soravtansine (Elahere) to treat patients whose cancer cells have a protein on the surface known as folate receptor-alpha (FRα), and who have previously not responded to or are no longer responding to treatment with ‘platinum-based’ chemotherapy, and who have already received one to three prior treatments.
Mirvetuximab soravtansine has been approved via the International Recognition Procedure (IRP). MHRA granted the new marketing
MHRA approves adrenaline nasal spray - the first needle-free emergency treatment for anaphylaxis in the UK
This first needle-free nasal spray formulation of adrenaline for the emergency treatment of anaphylaxis in the UK represents an important new option, adrenaline auto-injectors remain a vital and potentially life-saving treatment, giving people experiencing anaphylaxis valuable time before emergency help arrives.
Adrenaline (epinephrine) nasal spray is a ready-to-use single dose nasal spray that delivers its entire contents (2mg) upon activation. Patients should always carry two nasal sprays with them in case a second dose is needed and let friends or family know they have them in case of an emergency.
This medicine has been approved through the International Recognition Procedure (IRP).The approval was granted to ALK-Abelló A/S
New injection for easier prevention of HIV infection
EMA has recommended granting a marketing authorisation in the European Union (EU) for Yeytuo (lenacapavir) for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents at high risk of becoming infected. Yeytuo will facilitate PrEP uptake and compliance because it only has to be administered twice a year via a subcutaneous injection.
Yeytuo was evaluated by the CHMP, EMA’s human medicine committee, under an accelerated timetable because it is considered to be of major public health interest in the EU and the rest of the world. The CHMP simultaneously reviewed the medicine for the EU market, under the centralised procedure, and for non-EU countries, under the ‘EU-Medicines for all’ (EU-M4all) programme.
This aims to make medicines that address unmet medical needs or are of major public health interest available in Europe and globally faster, while avoiding duplication of efforts from regulators. Experts from the World Health Organization (WHO), Uganda, Zambia, Kenya, Nigeria, Zimbabwe, South Africa, Thailand and Vietnam participated in the assessment.
The applicant for Yeytuo is Gilead Sciences Ireland Unlimited Company.
Conferences webinars etc.
Workshop on a tailored clinical approach in biosimilar development
This Biosimilar Medicinal Products Working Party (BMWP) workshop takes place as part of the consultation process.
The event supports the implementation of the BMWP’s workplan and aligns with broader efforts to facilitate proportionate, science-based regulatory pathways for biosimilars. It takes place during the public consultation period, which runs until 30 September 2025.
The workshop brings together EU and non-EU regulators, international partners, patient and healthcare professional organisations, academia, and industry stakeholders to discuss the proposed approach and provide feedback on the draft document.
Objectives of the workshop:
· gather targeted feedback from stakeholders on the draft reflection paper;
· promote awareness and understanding of the proposed tailored approach to biosimilar development;
· support the finalisation of the reflection paper by considering practical insights and scientific perspectives.
Registration for online attendance is open till 15 Sept. In person attendance is by invitation only.
PHSS Annual Conference
This year's PHSS Annual Conference is in association with BioMerieux.
There will be a site tour locally (TBC) and a networking dinner, which BioMerieux is sponsoring.
The conference day on the 17th of September, is packed with keynote speakers, industry SME, and MHRA (TBC).
PHSS - QP Forum Conference 2025
The Conference is designed for all QPs and aspiring QPs. Listen and interact on topics and the latest developments regarding the duties and responsibilities of QPs.
This annual event has proved valuable to those in the QP role.
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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