1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance Updates in May 2026

Did you know that the following Regulatory Guidance was updated in May 2026?

HPRA (IE): 

  • Promoting medicines to the public on social media – the HPRA has launched a new webpage, setting out clear information on the laws that apply to advertising human medicines for the public
  • HPRA webinar – There will be a webinar hosted by the HPRA on the 19th June 2026 on recent updates and developments in the veterinary medicine regulation

MHRA (UK): 

  • Find product information about medicines page is updated to add
    • Guidance with updated additional monitoring list April 2026
  • MHRA opens UK-wide consultation on redefining gene therapies on their proposed changes to how gene therapies are legally defined in UK legislation
    • This will ensure UK regulation keeps up with advances in gene therapy, synthetic biology, and gene editing technologies
  • MHRA launched a public consultation on a proposed new Rare Disease Therapies Framework that would introduce significant regulatory innovation to the UK’s rare disease landscape
    • MHRA is calling on the pharmaceutical and life sciences industries to play a central role in shaping the final framework.
  • MHRA welcomes submissions for participation in MHRA-NICE Real World Evidence Scientific Dialogue
    • The expression of interest form is accessible since the 20 May 2026. Expression of interest guidance for applicants is also available
  • MHRA published the latest ‘conformity assessment routes flow chart’ to help companies conform with the legal requirements for placing medical devices on the market
  • MHRA request that current or potential Marketing Authorisation Holders (MAH) provide information on planned or potential future submissions to the MHRA
    • Template spreadsheet (MS Excel) can be downloaded, filled in with as much information as possible and returned to the MHRA by email (where the information will be treated sensitively and securely)

EMA (EU wide):

As always the EMA regularly updates their website – here are some of the highlights from May 2026.

  • Medicines – Human:     
    • Revamp of marketing authorisation assessment templates
    • Q&A on implementation of Ph. Eur. Medicinal Product Monographs (MPM)
    • Updated questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document for assessors
    • Good manufacturing practice: Multistakeholder workshop on expert contributions to the artificial intelligence guidance development (Annex 22).
    • Updated timetable for Initial (Full) marketing authorisation application – ATMP
    • Updated timetable for accelerated assessment request for initial marketing authorisation applications
    • Updated Product-specific bioequivalence guidance
  • Medicines – Veterinary: 
    • Updated QRD veterinary combined label-leaflet template v.9.1
    • Updated guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 and on the documentation to be submitted pursuant to those variations
  • Upcoming Webinars: 
    • Clinical Trials Information System (CTIS): Information day will be provided by the EMA on the 17 June 2026 on-line
    • Product Management Service (PMS): Information day will be provided by the EMA on the 09 June 2026 on-line
    • Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP) Inspectors Working Group is organising a two-day workshop on 30th June 2026 to help shape a risk-based approach to the use of generative artificial intelligence (AI) in medicines manufacturing.

CMDh (MRP/DCP):

  • Updated – list of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
  • Contact Point List was updated
  • Updated – CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure)
  • Correction to “Q&A – List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008 as amended” to reflect the principles of Q&A 7.3.1. in the European Medicines Agency post authorisation procedural advice for users of the centralised procedure, which addresses the impact of changes in the clinical use of a product on quality documentation

eSubmissions:

  • Updates to web eAF (the most recent one released to production on 11 May 2026) is now available on the eSubmission PLM Portal eAF web page
  • As of 5 May 2026, the Readable IDs functionality is released within the European Shortages Monitoring Platform (ESMP). This improvement simplifies data entry, reduces the need for cross-referencing external lists, and enables more accurate verification of submitted information
    • Live training recording & presentation: The training webinar held on 14 April 2026 introduced the readable IDs alongside other improvements, providing practical guidance to support day-to-day activities. EMA encourage the review of this training recording and presentation on the dedicated event page on EMA’s website for familiarisation with the new features.
    • Updated guidance: The updated ESMP MAH User Guide and ESMP MAH Implementation Guide have been released to accommodate this new functionality. These documents provide detailed instructions on using readable IDs.

 

For any support you might need to navigate the latest guidance or just for assistance with your EU and UK procedure preparations, submissions, responses, etc., you can contact us on info@eureg.ie

Written by

Marian Winder

Marian Winder 1

Marian Winder 1

1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in March and April 2026

Did you know that the following Regulatory Guidance was updated in March and April 2026?

HPRA (IE): 

  • HPRA guidance issued in relation to EMA list of ingredients restricted or prohibited for use in cosmetics from 1st May 2026
  • 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.

MHRA (UK): 

  • Apply for a licence to market a medicine
    • Updated guidance on electronic submissions to the MHRA
  • MHRA Portal: register to submit forms
    • Updated guidance to add MHRA Portal registration form
  • Medicines licensing: how to apply
    • Updated guidance on varying, renewing and transferring ownership of a marketing authorisation were added
  • Clinical trials for medicines: notifiable trials.
    • Updated guidance on ‘Applications that need expert advice’ to change timeline from 14 days to 28 days
    • Addition of the Confirmation of Notifiable Trial Criteria form and clarification that IND refers to investigational new drug (no change note needed)
    • The amended Clinical Trials Regulations took full effect on 28 April 2026
      • As such, this guidance should now be considered effective and is no longer in draft

EMA (EU wide):

As always the EMA regularly updates their website – here are some of the highlights from March and April 2026.

  • Medicines – Human:     
    • A Q&A clinic on the eAF took place on the 9th March 2026
      • the slides from this session can be found on the EMA website.
      • The updated Variation Regulation Classification Guideline has been made available in both the interactive pdf eAF 28.0.0and in the PLM Portal web-based variation form January 2026 version.
      • Users are reminded to verify the accuracy and content of the selected scopes (including the conditions and documentation), before submitting the form to the relevant health authorities.
      • The EMA will introduce mandatory use for CAPs as of 1 September 2026.
    • Updated pre-authorisation guidance
    • Updated post-authorisation guidance
    • Updated guidance on Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products
    • Updated validation checklist for initial marketing authorisation applications – biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)
    • Updated Product Management Service (PMS) – Frequently Asked Questions (FAQs)
  • Medicines – Veterinary: 
    • Updated guidance on variations not requiring assessment (veterinary medicines)
    • Updated guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
    • Updated guidance on transferring a veterinary marketing authorisation
    • Updated pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6); Question 2.1.5 in “Preparing the dossier” section
    • Updated QRD veterinary Appendix I – Adverse event (PhV) MSs reporting details

CMDh (MRP/DCP):

  • Updated “Examples for acceptable and not acceptable groupings for MRP/DCP products” to reflect the possibility of accepting the grouping of related Type IA and Type IAIN variations outside the annual update
  • Updated “Chapter 1 – CMDh Best Practice Guide for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharing” to clarify the allocation of procedure numbers for annual update of Type IA variations
  • Updated “Chapter 6 – CMDh BPG for the Processing of (Super-) Grouped Applications in the Mutual Recognition Procedure” to reflect the agreement on the possibility of accepting the grouping of related Type IA and Type IAIN variations outside the annual update
  • Updated Questions and answers on the Paediatric Regulation to reflect update to align with the new EC guidelines on the details of the various categories of variations and operation of the procedures
  • Updated “Best Practice Guide for Article 45 and 46 – Paediatric Regulation – EU Worksharing Procedure” to align with the new EC guidelines on the details of the various categories of variations and operation of the procedures. Other clarification updates were included

eSubmissions:

  • Mandatory Use of PLM Web-Based eAF for CAPs: To continue advancing the adoption of the PLM web-based eAF, the EMA will introduce mandatory use for CAPs as of 1 September 2026.
  • EU eCTD v4.0 validation criteria v1.1 published. eCTD v4.0 tool vendors may now begin implementing the new rules, and the updated validation criteria will become applicable starting 15 July 2026.

 

For any support you might need to navigate the latest guidance or just for assistance with your EU and UK procedure preparations, submissions, responses, etc., you can contact us on info@eureg.ie

 

Written by

Marian Winder

Marian Winder 1

Marian Winder 1

1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in February 2026

Here are the main highlights of Regulatory Guidance updated in February 2026

HPRA (IE): 

The HPRA promoted the Facilitating and Accelerating Strategic Clinical Trials (FAST-EU).  FAST-EU is a pilot initiative aiming to accelerate the assessment and authorisation of clinical trials running in multiple EU/EEA countries. The pilot is currently open for submissions and is expected to run until early 2027.

MHRA (UK): 

The MHRA published a few updates:

  • Medical devices regulations:
    • Targeted consultation on the indefinite recognition of CE marked devices in Great Britain.
  • Addition of the latest Additional Monitoring List for Jan 2026
  • New information on responsibilities and reporting on nitrosamine impurities

EMA (EU wide)

As always the EMA regularly updates their website – here are some of the highlights from February

  • Medicines – Human:
    • Updated validation checklist for Type II variations
    • Concept paper on the revision of the guidelines on Good
      Manufacturing Practice for medicinal products – Annex 15
      – Qualification and Validation. Public consultation began on 09th February
    • ICH M15 Guideline on general principles for model-informed drug development, document updated
    • Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form, document updated
  • Medicines – Veterinary:
    • Guideline on quality aspects of mRNA vaccines for veterinary use, Public consultation began in February
    • Question and answer on the information contained within section 4.2 of the SPC on pharmacodynamic properties for pharmaceutical products
  • Annual fees payable to the EMA, page updated
  • Reflection paper on the qualification of non-mutagenic impurities
  • FAQ document published to address common queries and provide guidance on the European Shortages Monitoring Platform (ESMP)
  • List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs) excel is updated
  • List of contact information for the national competent authorities in the EEA page updated
  • Updated PRAC report templates
  • Guidance on Good Pharmacovigilance Practices (GVP) updated
  • Summary from the industry stakeholder webinar on the revised guideline on the environmental risk assessment of medicinal products for human use
  • The next eAF Q&A will be on the 9th of March

CMDH (MRP/DCP):

  • Agenda for the 24-25 Feb Meeting
  • Report from the CMDh meeting held on 27-28 January 2026
  • Q&A – Generic Applications

eSubmissions:

  • Updated PLM Portal eAF Release notes (version: 1.2.1.6 – Release date 16/02/2026)

For any support you might need to navigate the latest guidance or just for assistance with your procedure preparations, submissions, responses, etc., you can contact us on info@eureg.ie.

 

Written by Fiona Downey

Fiona Downey

Fiona Downey

1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in January 2026

Were you aware that the following Regulatory Guidance was updated in January 2026?

 

HPRA (IE): 

  • Updated fee guidance document for Human medicinal products

MHRA (UK): 

The MHRA have been very busy updating their website in January – here are some of the highlights

  • Medicines: International Recognition Procedure
    • Updated dates indicating the submission deadlines for IRP Route B applications in the IRP Guidance page
  • Medicines: Apply for a variation to your Marketing Authorisation
    • Updated to add new section on Type II variations – ‘Variations to add a new therapeutic indication’
  • Medicines: Statement on new review of paracetamol safety during pregnancy
    • Paracetamol should be taken as directed in the patient information leaflet
  • Medicines: that you can export from the UK or hoard
    • Updated to add: Aspirin (strength: all; pharmaceutical form: all); and Ifosfamide (strength: 1g/2g; pharmaceutical form: powder for solution for injection vials)
  • Medicines: get scientific advice from MHRA
    • Removed info box at the top of the page as out of date
  • Human and Veterinary: Register of licensed manufacturing sites
    • Updated to add the MS and MANSA registers for January 2026
  • Updates to the Orphan Register
  • Early Access to Medicines Scheme: Overview
    • Updated scientific opinion dates for EAMS 2026
  • Clinical Trials: apply for authorisation in the UK
    • Updated to provide link and information under ‘Combined review of an investigative medicinal product and medical device – IMP+Device’
  • Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessment and agile regulation
  • Borderline products: how to tell if your product is a medicine
    • Updated to add Statistics table for May-October 2025

EMA (EU wide)

As always, the EMA regularly update their website – here are some of the highlights from January

  • EMA post-authorisation guidance – updated
  • Dates of 2026 Scientific Advice meetings and submission deadlines
  • Medicines: Use of Paracetamol during pregnancy unchanged in the EU
    • Recent publication confirms no increased risk of autism, ADHD or intellectual disability
  • EMA and FDA set common principles for AI in medicine development
  • IRIS guide for applicants – updated
  • Meeting highlights from Pharmacovigilance Risk Assessment Committee (PRAC)
  • Meeting highlights from Committee for Veterinary Medicinal Products (CVMP)
  • Published the Annual report of the Good Clinical Practice (GCP) Inspectors working group 2024
  • Q&A about the clinical study data proof-of-concept pilot for industry – published
  • One Health Approach
    • updated to include ‘One Health task force‘ section
  • Q&A clinic: New Variation classification in eAF (recording available)
  • 3 year rolling work plan for the Quality Innovation Group (QIG)

CMDH (MRP/DCP):

  • Updated ‘contact points’ excel
    • This excel provides names, email addresses and phone numbers for seeking advice from each member state in the EU/UK for regulatory procedures
  • National recommendations for requests to act as RMS – updated
  • Recommendation for classification of unforeseen variations according to Article 5 – corrected
  • ASMF workshare procedure user guidance – updated

eSubmissions:

  • Updated PLM Portal eAF release notes
  • European Shortages Monitoring Platform (ESMP)
    • Expanding to include: new tools and features to better support stakeholders in preventing, managing and mitigating medicine shortages
  • Updated Variation Regulation Classification Guideline
    • has been made available in the interactive pdf eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version
  • Go-Live announcement for EU eCTD v4.0 optional use for Centralised Procedure new MAAs

 

For any support you might need to navigate the latest guidance or just for assistance with your procedure preparations, submissions, responses, etc., you can contact us on info@eureg.ie.

 

Written by Alice D’Alton

Alice Dalton 1

Alice Dalton 1

ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Tailored development of biosimilars without efficacy and safety studies – is this the future?

With growing experience and coverage of the biosimilar market, regulatory strategies must evolve to balance scientific rigor with the need for efficient development.

One of the currently most debated topics in the biosimilar arena is the potential waiver for traditional efficacy and safety studies, a move that could significantly reduce development timelines and costs.

This session focused on the increasing interest in shifting the emphasis to establish similarity mainly based on CMC comparability data, as opposed to relying on results from comparative clinical efficacy trials (CES).

The session explored the scientific rationale behind using robust CMC evidence as the cornerstone of biosimilar approval, while addressing concerns regarding the adequacy of clinical data.

Experts in CMC presented their views on how advanced manufacturing technologies, analytical techniques, and product characterization can generate the necessary evidence to support a waiver for extensive efficacy and safety studies. These experts shared insights on how consistent manufacturing and comparability of biosimilars can be sufficiently demonstrated through state-of-the-art analytical methods, highlighting the potential for regulatory flexibility in this area.

On the other hand, clinical specialists provided arguments from a clinical point of view, discussing the feasibility and concerns about the lack of efficacy and safety data in these developments. They examined the implications of waiving clinical trials, particularly in terms of patient safety, real world outcomes, and public confidence in biosimilars.

By bringing together experts from both the CMC and clinical fields, this session provided a comprehensive, balanced view of the challenges and opportunities in biosimilar development.

Points to note:

There is 20 years of experience now in EU (both Industry and Regulators)

Are Clinical efficacy studies (CES) still needed?

  • Analytical tools are more sensitive to detect differences than CES.
  • CES can not always contribute relevantly to decision making and could not solve PK issues
  • Trials can cost $100-$300 million dollars
  • Biosimilar void is coming (many products off patent soon with no generics in development)
  • Regulators are getting ready for less clinical data to make decisions (when appropriate)
  • You do need a comparative PK study, supportive safety/immunogenicity data, CES may only be needed to answer outstanding scientific questions
  • Quality and Non-clinical evidence grounded in comparability (ICH Q5E) – better knowledge of mode of action today than before

EMA/CHMP/BMWP/60916/2025 (Reflection paper – https://www.ema.europa.eu/en/reflection-paper-tailored-clinical-approach-biosimilar-development)

EMA/CHMP/138502/2017 (Reflection paper – https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-statistical-methodology-comparative-assessment-quality-attributes-drug-development_en.pdf – use it for discussion and clarification with Regulators. It won’t always be applicable to your product)

  • Impacts on potency (discussion in dossier required), Critical Quality Attributes (CQA) risk ranking approach (examples given on how to justify)
  • Quality of Reference Product can differ over time and so needs to be monitored by R&D, PK/PD study data becomes essential when CES is excluded.
  • Protein quantity similarity assessment is necessary
  • PK/PD could be used to supplement immunogenicity data requirements (via better assays)
  • Ask Regulators not to get bogged down in differences that don’t matter (convince them in your submission)

EMA perspective:

  • Quality data has evolved
  • Reflection paper on statistics is a tool box of options (not a requirement).
  • Industry should use Quality data as appropriate.
  • Immunogenicity topic is still under discussion at EMA.
  • Structural analysis needs to be robust, guideline for biosimilars is being developed.

Q&A:

  • Discuss CES requirement with EMA in scientific advice – Application must be mature enough to allow for Regulator advice, see reflection paper – Approach them after batch manufacture once you can see how things are aligning
  • Prescribers may need help to accept Biosimilars approved without CES.
  • IPRP workshop was valuable (https://admin.iprp.global/sites/default/files/2024-07/IPRP_BWG_Final%20IPRP%20Scientific%20Workshop%20Summary%20Report_2024_0506.pdf)
  • Wider community is pretty open to waivers, follow-up with NCA initiated (Reflection paper).
  • WHO guidance is already followed by many countries and also mentions CES waiver.

Written by

Alice D’Alton

Alice Dalton 1

Alice Dalton 1

ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Session 8 – Human – ePI is on Fire! (I mean FHIR !!)

This session focused on the regulatory implications and readiness strategies for the implementation of electronic Product Information (ePI) based on the HL7 FHIR® standard.

As outlined in the EU pharmaceutical strategy and reinforced by EMA’s digital initiatives, the structured, interoperable ePI format will play a critical role in improving the accessibility, reliability, and lifecycle management of product information.

Regulatory authorities and marketing authorisation holders must prepare for changes in submission formats, review procedures, and data governance models.

The session provided an overview of current status of the EU ePI project including linking to ePI from EU medicine packages, regulatory frameworks, and anticipated timelines.

Practical insights were shared on how regulatory professionals can adapt internal processes and evaluate IT infrastructure needs to ensure compliance and facilitate the seamless integration of FHIR-based ePI into existing regulatory operations.

Points to note:

  • Guidance on PLM portal (incl style guide). ePI pilot report available. Reflection paper published Q2-2025. You Tube videos. Quarterly system demos ongoing
  • Free software from regulators via PLM portal. Pilot showed it took just 4 hours for a company to create ePI from scratch using these tools
  • Technology used is the FHIR common standard for healthcare data exchange. Harmonised EU approach. PLM portal storage and access (FHIR repository)
  • User testing would still be required in some form in future
  • Better supply chain management for industry 
  • 73% of delegates at this session said their company have not implemented any ePI process yet
  • ePI will be submitted as additional material alongside word and pdf version for assessment (for a while)
  • Once ePI is approved it is put into the central repository and then is available to the patient for download
  • Go live for CAPs and early adoption NCA is planned soon (ePI type 1) – likely with New legislation implementation (~2028) – implementing act may have more specific information to clarify ePI requirements
  • What does the future look like?: ePI type 4 is under development (ePI 2 & ePI 3 exist but not implemented). ePI type 5 is in the idea stage
  • ePI is already implemented in other jurisdictions so EU needs to catch up

Written by

Alice D’Alton

Alice Dalton 1

Alice Dalton 1

ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Session 6 – Human – How AI is Transforming Regulatory Approaches towards CMC

This session explored the transformative role of Digital tools including Artificial Intelligence (AI) in enhancing Chemistry, Manufacturing, and Controls (CMC) processes within the pharmaceutical industry.

As AI technologies continue to advance, their integration into CMC activities offers exciting opportunities to streamline development, optimize manufacturing, and improve regulatory decision-making.

Points to note:

  • The Quality Innovation Group (QIG) supports the development of new technologies throughout the product lifecycle. They want to collaborate with as many groups (regulators) as possible to avoid silos (contact qig@ema.europa.eu)
  • Revision of EU GMP guide Annex 11, 22 and Chapter 4 ongoing (all under stakeholder consultation – comments by 7th October)
  • New Annex 22 does not cover Generative AI or Large Language Model (LLM). Detailed overview of the requirements and expectation were presented
  • UK: Centres of Excellence for Regulatory Science and Innovation (CERSIs) & MHRA – Regulatory science and innovation network. They are looking at the regulatory challenges that are slowing the adoption, and realising of the full potential of, digital tools so they can be used in lieu of generating new data. Using VERA (virtual assistant) to find and review content of documents they already have

https://www.gov.uk/government/news/mhra-showcases-next-phase-of-regulatory-science-to-bring-innovative-treatments-to-patients-sooner

  • Digital CMC sandbox for testing digital tools in a safe place
  • Industry perspective: using models whenever possible and LLM, GenAI, Deep Learning (DL), Neural Network (NN) for e.g. visual inspection on production floor, Machine Learning (ML). 
  • EMA/90634/2024 guidance – decision tree under consultation
  • Risk management approach to AI (EU AI act)
  • ISPE guideline 2025 – use in parallel with GAMP 5 (2022)
  • Panel discussion: Models already used in manufacturing for years, AI is an evolution of digital tools already being used (not a revolution)
  • AI being used to generate annual product reviews, analysis of trends.
  • Regulators are exploring possibilities of using AI for CMC review (there is potential)
  • Industry needs Regulators around the world to accept the data generated or it will not be cost effective to implement process modelling technology
  • Training will be critical

Written by

Alice D’Alton

Alice Dalton 1

Alice Dalton 1

ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Session 5 – Human – Programme COMBINE – Clinical Trials with Medicine + Medical Device

This session looked into opportunities and challenges with application procedures when performing a combined clinical trial in Europe, that involves a medicinal product and an in vitro diagnostic (IVD), or companion diagnostic (CDx) and/or a medical device (MD) component.

The clinical trial application for the medicinal product is submitted under the Clinical Trial Regulation (CTR) via CTIS, while the device/diagnostic follows different national procedures.

An update on the COMBINE project was provided.

The device regulation (MDR and IVDR) has introduced major changes and has been suggested as a contributing factor to the decrease in the number of clinical trials in Europe.

The European Commission and EU Member States have launched the COMBINE initiative to propose solutions for combined trials (drug using a device in a clinical trial), specifically looking at the interplay of IVDR, MDR and CTR, also identified as one of “most important issues” by stakeholders ACT-EU workplan ‘25-’26.

The panel discussion explored whether the proposed solutions stemming from this highly welcomed initiative are already demonstrating benefits. It also offered concrete strategies to ensure the European clinical trial ecosystem is well-suited to promote the conduct of clinical trials in Europe.

Points to note:

  • Guidance will be published but in the meantime please seek scientific advice
  • The COMBINE project team would like to see devices included in the Regulatory sandbox concept
  • There are 8 applications in the pilot phase of COMBINE already
  • UK involvement in the project could be beneficial in order to manage the complex requirements currently in place for Northern Ireland and to encourage clinical trials to be located there. 

Written by

Alice D’Alton

Alice Dalton 1

Alice Dalton 1

ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Session 4 – Human – Revision of the EU variation Regulation

The EU variation Regulation was updated in March 2024 and the new Detailed guideline for classification of variations [last dated from 2008, last update 2013] was published this month.

Nevertheless, this is the first step, limited by the current legislation, and a second step is awaited after the new EU general pharmaceutical regulation is in force (expected 2028).

The current European Commission updates simplify the requirements and procedures, modernise the framework, adapt the rules for grouping and work-sharing, adapt the classification for some products, reduce administrative burden, and implement a risk-based approach.

This session presented an overview of the original goals of the revision, the new changes in the management of post-approval changes; including a comparison of the previous and proposed classifications with statistics and impact for both regulators and industries in term of volume of variations being generated.

The session discussed opportunities to continue re-inventing both submission policies and processes for post-approval changes in the EU for centrally and nationally registered products.

Points to note:

  • Second revision will come with implementation of new Directive ~ 2028 and will aim to reduce the number of Type IA variations 
  • Reinforcement of Annual Reporting and now mandatory worksharing (e.g. Update RMP, ASMFs, CEPs, etc.) discussed
  • Supergrouping can now include NAPs and Type IA variations
  • Worksharing (WS) now includes CAP, MR/DC and NAPs. New Declaration in eAF. Letter of Intent required.
  • MEB have seen significantly increased in WS applications. MEB is seeing a decline in IB variations already. Supergrouping applications have also increased in NL. 
  • EMA Q&As are being compiled and will be published in Q4 2025 (e.g. Stability testing, classification of changes, skip/periodic testing, PLCM, etc.). More Q&As planned for Q1 2026
  • SPOR (referential lists) and eAF/PLM updates to follow
  • EMA encourages the use of the Change Management Protocol and hope to see it used more in future
  • Mandatory worksharing should be useful for both industry and Regulators, to increase efficiency and get faster approvals for multiple MAs
  • EMA allows the grouping of related IA and IAin despite the fact that variation regulation does not technically allow this (and it is not allowed for MR/DC), new guidance should help to clarify
  • Article 5 recommendations will remain as an option for variations that are not included in the new regulation
  • ICH Q12 should be reviewed in conjunction with new regulation and guidance

Written by

Alice D’Alton

Alice Dalton 1

Alice Dalton 1

ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Session 3 – Human – Applying Artificial Intelligence in Real-Life

Artificial Intelligence has already been a hot topic in numerous workshops, conferences, symposia and more in the past years. This session focused on questions such as:

How is it actually being applied in pharmaceutical development and regulation?

Where has it made the most impact in the field?

The session put aside the high-level discussions on what is possible with AI and discussed the real-life examples of where AI is already making a difference.

Points to note:

  • Auto dossier was presented and Demo shown of how it can automate CTD building
  • Collaborare: Unleashing the power of
    patient voices using AI.  This was presented and showed how patient voices can be added to decision making with AI tools
  • The Paul-Ehrlich Institut presented their ICSR processing tool and its benefits
  • The EMA presented its Signal detection tool and it benefits
  • Large Language models are routinely used today by industry and regulators to aid decision making and streamline their processes leaving more time for analysis and less time spent on admin, data collection and sorting
  • The AI workplan to 2028 is published – ‘Data and AI in medicines regulation
  • Fears of error introduced by AI was tempered by asking why we expect 100% accuracy from AI when humans do not output 100% accuracy all the time either
  • AI guidance from EMA will be principles based to future proof it as much as possible. Reflection papers will be followed by guidance in time

Written by

Alice D’Alton

Alice Dalton 1

Alice Dalton 1

Need help with all the regulatory jargon?

Check out our updated GLOSSARY OF ABBREVIATIONS AND ACRONYMS.

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