1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in August 2026

 

Title:  Regulatory Guidance updates in August 2026.

Body text:

Regulatory Guidance updates in August 2026 – ERA have tracked them for you!

HPRA (IE): 

  • Updated HPRA Guide to the Clinical Trials Regulation
    • to reflect the full implementation of the Clinical Trials Regulation (CTR)
    • to align with current European and national guidance and best practices
    • updated to requirements and timelines for submitting notifications and trial results.

MHRA (UK): 

  • Updated guidance on “Guidance on pharmacovigilance procedures”
    • Added further information on EURD list under section 5.2 of guidance

EMA (EU wide):

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

Medicines – Human: 

  • Fees for human medicines updated:
    • Information about which fee reducations are applicable has been updated. Questions 1.2., 2.2., 4.2., 5.2., 6.1., 13.2 and 14.1. have been updated accordingly. Updated “European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure”
    • To include reference to “Further guidance on the use of the IRIS platform and how to prepare submissions is available on the dedicated IRIS website” in section 1.7.2
    • Remove reference in section 2.1.23 to “Eligibility requests should be submitted via EMA Service Desk, selecting the tab “Business Services”, category “Human Regulatory”
    • Section 2.2 is updated to include” the applicants should use the IRIS platform when applying for eligibility, selecting submission type “Eligibility and letter of intent”. Annex 1 (draft Summary of Product Characteristics) and Annex 2 (Justification for Eligibility) must be included in the request
    • Eligibility request should no longer be submitted via EMA Service Desk
    • Section 2.7 is updated in include “Applicants should use the IRIS platform when the previously indicated submission date of an upcoming application for marketing authorisation is changed, selecting submission type “Notification of changes”.
  •  
  • Reliance for post-authorisation changes: guidance for the pharmaceutical industry
    • EMA makes available guidance on how pharmaceutical companies can apply to a pilot programme that enables them to use reliance to submit post-authorisation changes simultaneously to multiple countries outside the European Union.

Medicines – Veterinary: 

  • Fees for Veterinary medicines updated:
    • Questions 1.2., 3.2., 4.2., 6.2., 11.2., 11.3. have been updated with information on fee reductions
  • Updated Marketing authorisation (veterinary medicines)
    • Steps involved in obtaining an EU marketing authorisationupdated to reflect the migration of veterinary regulatory business services from ServiceNow to the IRIS platform.
  • Updated Verterinary medicines marketing authorisation application pre-submission interaction request form
  • Updated Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6); Questions updated:
    • Is my veterinary medicinal product eligible for evaluation under the centralised procedure?
    • How and when should the request for eligibility for the centralised procedure be sent to the European Medicines Agency?
    • What is the procedure for appointment of CVMP rapporteurs/co-rapporteurs and their assessment teams?
    • In which cases is my veterinary medicinal product eligible for an accelerated review?
    • How is a pre-submission interaction conducted at the EMA?

Upcoming Webinars: 

    • EMA risk management information day: 8th September 2026

 CMDh (MRP/DCP):

  • Update to “Guidance published by Member States on the implementation of the Falsified Medicines Directive”

eSubmissions:

Human Variation interactive PDF eAF v1.28.1.0 version available

  • Minor version 28.0.0of the interactive PDF electronic application form (eAF) for human marketing authorisation application is available on the eAF website.
    • The new version brings a minor change, affecting the substances dropdown in section 2.6.1.
      • The previously published version 1.28.0.0 should be exported and re-imported in the newly published PDF. The steps are explained in the following guidance, page 10: Technical User Guide for eAF.pdf.
      • Reminder:all the new form that are published need to ‘Trusted’. Follow the Practical user guide for electronic Application Forms (eAF) for human and veterinary products in the EU, page 11
      • For the implementation timeline of the 1.28.0.0 MAA forms, please consult the news from 30 June.Veterinary marketing authorisation application (MAA) form naming for Centrally Authorised Products (CAPs)
      • To support the automated processing of CAP(centrally authorised products) Veterinary marketing authorisation application (MAA) submissions at EMA, the electronic Application Form (Vet MAA interactive PDF eAF) included in the VNeeS package must follow a specific file naming convention. The eAF filename must contain the text: ema-form-eaf. Additional information may be included in the filename, provided that the string ema-form-eaf remains present.
      • Examples of acceptable filenames:
        • ema-form-eaf.pdf
        • ProductName_ema-form-eaf.pdf
        • ema-form-eaf_ProductName_v1.pdf

      Please note:

      • The text ema-form-eaf should be used only for the MAA eAF file.
      • No other file within the submission package should contain ema-form-eaf in its filename.

      EMA internal systems (IRIS) identify the eAF through an automated search for the string ema-form-eaf. If the naming convention is not respected, the system may be unable to identify the eAF correctly. As part of validation, submissions will be checked for compliance with this requirement. Where the naming convention has not been followed, applicants may be requested to resubmit the package with the correct filename.

      Applicants are therefore encouraged to verify the eAF filename before submission to avoid validation issues and potential delays in processing.

      Veterinary MAA eAF v1.28.0.0 – minor version available

      • Minor version 28.0.0of the interactive PDF electronic application form (eAF) for veterinary marketing authorisation application is available on the eAF website.
      • The new version brings a minor change, affecting the list of member states for sections 2.4.1 and 2.4.4 (UK(NI) is now included).
      • The previously published version 1.28.0.0 should be exported and re-imported in the newly published PDF. The steps are explained in the following guidance, page 10: Technical User Guide for eAF.pdf.
      • Reminder:all the new form that are published need to ‘Trusted’. Follow the Practical user guide for electronic Application Forms (eAF) for human and veterinary products in the EU, page 11.
      • For the implementation timeline of the 1.28.0.0 MAA Veterinary forms, please consult the news from 30 June.

      Updated PLM Portal eAF Release notes now available

      • An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.1.17 released to production on 18 August 2026 is now available on the PLM Portal and esubmission PLM Portal eAF
      • Reminder: mandatory use of PLM web-based eAF for CAPs – 1 September 2026
      • As announced in April 2026, the European Medicines Agency (EMA) is introducing the mandatory use for CAPs as of 1 September 2026. From 1 September date onwards, any human CAP variation submissions sent to EMA using the interactive PDF eAF will be rejected unless it is accompanied by a valid and justified technical reason preventing the use of the PLM web-based eAF (users are encouraged to review the full announcement made on 13 April 2026)
      • Before 1 September 2026, PLM portal eAF users should:

                        – Verify PMS data accuracy

                       – Ensure all users have the correct PLM Portal access and roles

                      –  Familiarise themselves with the PLM web-based eAF and available guidance materials

       – Practice creating submissions in the PLM portal. Draft forms  can be created and deactivated if not submitted.

      • Interactive PDF eAF may still be used for:
        • Large applications (over ~200 medicinal products) due to current performance limitations.
        • Medical Devices section issues.
        • Known PMS or OMS data issues affecting form completion.
        • Lack of PLM portal access or co-authoring capabilities.
        • Other technical issues that prevent timely completion of the PLM web-based eAF
      • Additional guidance:
        • Report resolvable issues through the EMA Service Desk: https://support.ema.europa.eu/esc
        • Use the interactive PDF eAF if issue resolution or service desk response times risk missing submission deadlines.
        • No service desk ticket is required for known limitations such as large applications, Medical Devices issues, or lack of PLM portal access.
      • To justify the use of the interactive eAF PDF, a new radio button will be introduced in the Delivery File User Interface (eSubmissions preparation) on 12 August 2026, after 18:00 CET. It is mandatory to confirm the use of the PLM portal eAF for all human variations (Type IA, Type IAIN, Type IB and Type II), for “Initial” and “Validation response” submission units.

       

      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 1

      Marian Winder 1

1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in July 2026

Regulatory Guidance updates in July 2026 – ERA have tracked them for you!

HPRA (IE): 

  • The SoHO Regulation: all you need to know to get started guideline was published by the HPRA
    • Are you involved in activities concerning Substances of Human Origin (SoHO) intended for human applications?
    • Are you a facility where SoHO are applied to patients such as clinics, sport clinics, dentists, gynaecologists, ophthalmologists and any organisation using or processing SoHO?
    • Are you planning to commence SoHO-related activities?
    • If so, the new SoHO Regulation 2024/1938 shall apply to you as of 7 August 2027
  • The Guide to Fees for Veterinary Products has been updated
  • Labelling requirements for cosmetic products containing fragrances covered under Regulation (EU) 2023/1545
    • The HPRA has published a new information page to help members of the cosmetics industry comply with the fragrance allergen labelling requirements introduced under Regulation (EU) 2023/1545.
  • Guidance on controlled drugs requirements, this updated document follows a targeted consultation held in February 2026 including:
    • Electronic registers
    • Background checks for personnel
    • Transportation of controlled drugs
    • Clarification on the definitions of ‘Operator’ and ‘Responsible Officer’
  • HPRA to support EU Council Presidency
    • The HPRA will actively contribute to Ireland’s Presidency of the Council of the European Union from July to December 2026

MHRA (UK): 

  • Updated guidance on “Variations to marketing authorisations (MAs)”
    • Added section ‘Deadlines for new therapeutic indication variations’ to the section ‘Variations to add a new therapeutic indication’
  • Updated guidance on Clinical trials for medicines: ending a clinical trial.
    • Clarified requirements and links to additional guidance for submission of results where the trial is sponsored by the holder of a UK marketing authorisation and involves the use of that authorised medicinal product use in a paediatric population
  • Updated guidance on “Best practice in the labelling and packaging of medicines”
  • Updated guidance on ‘Best practice guidance on patient information leaflets’
  • Updated guidance on “Register to make submissions to the MHRA”
    • to change wording from ‘substantial amendments’ to ‘substantial modifications’ in text
  • Updated guidance “Register medical devices to place on the market”
    • To add clarification concerning devices put into service only.
    • This update provides a link to a new guidance document on ‘Registration of medical devices Guidance on the registration requirements for medical devices placed on the market and put into service’

EMA (EU wide):

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

Medicines – Human: 

  • The presence of a Cover Letter is optional to use as from the 1st July 2026 for Type IA/IAIN variations for applications submitted via the Centralised procedure.
  • The following guideline has been amended as a result of this change:
    • European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
    • Questions and answers: Article 13 referral procedures
    • updated guidance clarifies the operational and practical handling of these procedures for marketing authorisation holders (MAHs) and applicants. Key operational steps following Committee for Medicinal Products for Human Use (CHMP) opinions are defined, including the timeline for re-examination requests, document annex submissions, and the translation check process
  • Questions and answers for biological medicinal products 
    • Section ‘Active substance specification Host cell proteins testing’ updated, under the question ‘What information on characterisation, biosimilarity, and comparability after manufacturing changes should be provided for effector functions of monoclonal antibodies’ has been updated.
      • New sections added:
        • Endotoxin Limulus Amoebocyte lysate (LAL) test
        • Biosimilar acceptance criteria
        • Vaccine potency testing
        • Extractable volume testing
        • Viral filtration
        • Pre-use filter integrity testing
        • Adeno associated virus (AAV) infectious titre test
        • Changes to master cell banks
        • Biosimilars containing recombinant hyaluronidase
        • Reference standard qualification protocols
  • Updated “Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form”
    • To reflect new regulations and align with the updated eAF submission portals

Medicines – Veterinary: 

  • New document on ‘Application for Transfer of Marketing Authorisation from Transferor to Transferee, attachment 1 (veterinary)’

Upcoming Webinars: 

    • EMA risk management information day: 8th September 2026

 CMDh (MRP/DCP):

  • The presence of a Cover Letter is no longer required as from the 1st July 2026 for Type IA/IAIN variations for applications submitted via DCP/MRP. Several guidelines including the Cover Letter Template for variations have been amended as a result of this change
  • The guidance on ‘CMDh Q&A – Post-Brexit’ was updated to:
    • clarify the information on reference medicinal products authorised in the UK (Q&A3)
  • The guidance on “Chapter 7 – CMDh Best Practice Guide on Variation Worksharing’ was updated to:
    • to clarify which worksharing procedures are included in CTS
  • The guidance on ‘Q&A – QP Declaration’ was updated to:
    • have been brought in line with the new Variations Guideline for medicinal products for human use. Answers for human and veterinary medicinal products have been aligned where possible. Other minor changes have been included.
  • Updated Type II variation Preliminary-Final Variation Assessment Report Type II variation assessment report
    • The CMDh agreed to merge the current Type II variation Preliminary Variation Assessment Report (PVAR) and Final Variation Assessment Report (FVAR) templates into one single VAR template. The updated template will give a complete overview of the procedural steps, all changes requested within the variation, and the assessment of the responses to the MSs request for supplementary information.
  • Contact Points were updated.

 eSubmissions:

Human Variation interactive PDF eAF v1.28.1.0 version available

  • Minor version 28.1.0 of the interactive PDF electronic application form (eAF) for human variation application is available on the eAF website, together with the associated release notes.
    • The new version brings the annual update checkbox (and the earliest implementation date), mandatory use of OMS for 3 sections and small bug fix.
    • The form can be used for new human variation applications submitted to EMA and NCAs from 3 August 2026. It will be mandatory to use the updated form for all new human variations submissions from 24 August 2026
      • Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

Veterinary Variation interactive PDF eAF v1.28.0.0 version available

  • Minor version 28.0.0 of the interactive PDF electronic application form (eAF) for veterinary variation application is available on the eAF website. Relevant release notes will be published at a later date.
    • The new version brings a change in the display of the section 4c.
    • The form can be used for new veterinary variation applications submitted to EMA and NCAs from 3 August 2026. It will be mandatory to use the updated form for all new veterinary variations submissions from 24 August 2026.
    • Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

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 June 2026

Regulatory Guidance updates in June 2026 – ERA have tracked them for you!

HPRA (IE): 

  • HPRA webinar – There was a webinar held on the 19th June 2026 on recent updates and developments in the veterinary medicine regulation
    • A recording should be made available in due course
  • Guidance on “Submitting a Request for a New National Application Procedure for a Human Medicinal Product” has been updated.
    • The HPRA has increased the non-refundable booking fee to €5,000
  • Guidance on “Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure for a Human Medicinal Product” has been updated.
    • The HPRA has increased the non-refundable booking fee to €5,000 to secure a DCP slot
  • Guidance on “New Applications and Variations to Wholesale Distribution Authorisations” has had a thorough update
    • changes can be viewed in the tracked version on the HPRA website.

MHRA (UK): 

  •  Updated “National Commission into the Regulation of AI in Healthcare: research, engagement and call for evidence findings”.
    • Findings call for evidence and wider research and engagement activities
  • Updated “Regulation of AI in Healthcare“
    • Findings have now been published, alongside a report summarising the wider research and engagement activities undertaken
  • MHRA has launched “AI sandbox” to accelerate medicines development and improve safety
    • will help make medicines safer, speed up development, and reduce reliance on animal testing
  • The MHRA and FDA have announced a new liaison programme, marking a significant step forward in strengthening the regulatory partnership between the UK and the US.

EMA (EU wide):

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

Medicines – Human:     

  • Updated “Member states contact points” for multiple topics
  • Updated “Checklist for the submission of day 215 translations for post-opinion linguistic review – human”
  • Updated “Timetable Safety referrals (Art 20 and Art 31PhV1 )”
  • Updated “Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe”
  • Updated “Regulatory Procedure Management in IRIS roadmap”
  • Updated “Reform of the EU pharmaceutical legislation”
    • The adopted acts of the new pharmaceutical legislation are expected to enter into force in 2026.
    • The following two years, until 2028, will serve as a transition period.
    • In this time interval, all EU Member States will need to update their national laws to align with the new rules.
  • New guideline on “Data recommendations for herbal medicinal products and traditional herbal medicinal products used in paediatric patients”
    • This document aims to provide basic recommendations for establishment of European Union herbal monographs with a paediatric indication
  • Good manufacturing practice: “Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)”
    • Working Group organised a two-day workshop to help shape a risk-based approach to the use of generative artificial intelligence (AI) in medicines manufacturing
    • Recording will be available in due course

Medicines – Veterinary: 

  • Updated “Guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances – Scientific guideline”.
    • This guideline replaces the CVMP related guidelines (“Guideline on requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue” (EMEA/CVMP/IWP/37267/2008) and the “Guideline on requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza” (EMEA/CVMP/IWP/222624/2006).

Upcoming Webinars: 

    • EMA risk management information day: 8th September 2026

eSubmissions:

  • Versions 1.28.0.0 of the interactive PDF electronic application form (eAF) for human and veterinary marketing authorisation application are available on the eAF website
    • Industry must use the updated eAFs, Version 1.28.0.0, for any new CAP MAA Veterinary or Human application submitted to EMA from 28 July 2026.
    • The forms can be used for new MAA applications submitted to the NCAs for NP, MPR, DCP and Subsequent Recognition Procedure (SRP) procedures from 1st September 2026.
    • It will be mandatory to use the updated forms for all new MAA submissions to the NCAs from 1st January 2027. 

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

ICH image - Generated by AI [Copilot]

ICH M4Q(R2): The Exciting Evolution of eCTD Modules 2.3 and 3.2

ICH M4Q(R2), “The Common Technical Document for the Registration of Pharmaceuticals for Human Use” is a revised draft version of the guidance that outlines how the quality sections of your medicinal product dossier are presented.

ICH M4Q(R2) was signed off as a Step 2 document in May 2025. Public consultation closed in October 2025. In February 2026 an overview of the comments were published. It was 145 pages long! These comments will be taken into consideration by ICH M4Q (R2) Expert Working Group in the context of Step 3 of the ICH process. Step 4 is aimed to be adopted by June 2027.

The ICH M4Q(R2) revision marks an exciting evolution for eCTD Modules 2.3 and 3.2, modernising the Quality section to fully support emerging therapies and structured digital data.

Its objectives are to improve submission and assessment efficiency, resulting in accelerated access to pharmaceuticals by way of the six ‘E’s:

  1. Encouraging global convergence of science- and risk-based regulatory approaches in the preparation of dossiers.
  2. Explaining and defining the organisation and positioning of information for Modules 2 and 3.
  3. Enriching communication between regulators and applicants and enhancing lifecycle and knowledge management.
  4. Embracing product and process innovation.
  5. Enabling efficient use of digital tools for submission and assessment and preparing for the closely linked, upcoming ICH guideline on structured pharmaceutical quality submission.
  6. Elucidating regulatory expectations and supporting efficient assessments, decision making, and actions.

For industry, it hopes to

  • clarify regulatory expectations
  • facilitate the application of the enhanced ICH quality strategy/vision
  • streamline regulatory application preparation
  • improve the quality of submissions
  • facilitate data and information management
  • promote communication with regulators
  • and foster harmonisation and standardisation of data/information requirements for regulatory submissions, while increasing regulatory convergence

But what does this ICH update mean for you?

Module 2.3 will no longer just be a retrospective summary of Module 3. It will serve as the basis of regulatory assessment and will facilitate lifecycle management.

It will be a comprehensive overview of the product and core quality information. Its components will apply science- and risk-based principles.

Module 3 will serve as a repository for the detailed descriptions of methods, data, and other relevant quality information that supports Module 2.3

Most subsections will follow a ‘DMCS’ model:

  • Description: Identifies the material and its key characteristics;
  • Manufacture: Outlines the production process and process controls;
  • Control: Describes quality control measures such as specifications;
  • Storage: Provides container closure system, stability, storage condition, and retest period/shelf life.

 Implementation

As you will see R2 is simply not just a reorganisation of information, it will require careful and detailed planning and efforts to implement. HOWEVER, clarification on transition and implementation timelines are awaited.

Future

Here at ERA, we will keep up to date on this topic, as it evolves, by attending workshops and webinars when they become available.

We hope to see the publication of clear guidance from the regulators and a pragmatic approach adopted (especially for legacy products). We wouldn’t say no to a nice little Q&A document either…

If you would like to discuss any of the above and if you need support with any of your future applications, we are ready to assist you and your team. Feel free to contact us and we will be happy to help.

Written by

Fiona Downey

Fiona Downey 1

Fiona Downey 1

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

Help Support Advise Guidance 21 11 19

You need to apply Type IA Annual Reporting in the EU in 2025

The Type IA Annual Update, also known as the “Annual report”, is a single submission of all the Type IA variations (not requiring immediate notification) which have been implemented during the previous twelve months.

The Annual report should be submitted as close to 12-month deadline as possible, but ultimately no earlier than 9 months and no later than 12 months after the first implementation date of the Type IAs included in the report.

 

Meaning of implementation for type-IA variations:

For quality changes, ‘implementation’ is when the company makes the change in its own quality system.

This implementation date must be carefully planned and recorded to facilitate submission of your Annual Reports.

 

How to plan the submission of your Annual Report:

As submission of the Annual report is dependent on the implementation of the first type IA variation, its submission date can change every year.

It is very important to note that the Type IA Annual report must fulfil the variation conditions for grouping (or super-grouping if it concerns more than one marketing authorisation).

It is expected that Type IA variations included in an Annual report will not be rejected. However, if rejected, Type IA variations from the annual report can be resubmitted as individual Type IAs immediately (outside of an annual report).

 

CMDh confirmed that although not specified in their guidance, Type IA variations implemented before 1 January 2025 can still be submitted as single type IA variations according to the current rules. The EMA confirmed that Type IA variations implemented in 2024 and not submitted to the Agency by 31 December may also be submitted by MAH no later than 12 months after implementation.

 

Therefore, Type IA variations implemented from 1 January 2025 should be submitted as part of the Annual report.

Type IAs can still be submitted outside the Annual report in the following cases:

  • If they are part of a grouped Type IB or Type II variation
  • If they are part of a super-grouping variation
  • If it involves the resubmission of a Type IA variation previously refused in the Annual report (12-month reporting period is criteria in this situation)
  • In exceptionally cases which should discussed and agreed with the EMA/NCAs.

 

eAF:

There are no current plans to amend the eAF to reflect Annual Reporting, instead, Applicants are advised to include a note in the cover letter and an additional note in the eAF scope to clarify that the application relates to the Annual Update of Type IA variations e.g. as foreseen in the updated Cover letter template:

<Annual update of type IA variation(s)

[X] We confirm that the annual update is submitted within 12 months following the implementation of the first type IA variation applied for in this notification. Implementation date of the first type IA variation:      >

 

If you need any assistance with planning and submission of your Annual Reports, contact us and we will be happy to help.

 

Written by

Fiona Downey

Fiona Downey 1

Fiona Downey 1

pharma vigilance

Back to Basics – The Risk Management Plan (RMP)

The Risk Management Plan (RMP) documents the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks.

The RMP should be updated throughout the life cycle of the product, for example;

  • if there is a change in the list of the safety concerns
  • when there is a significant change in the existing additional pharmacovigilance activities
  • if an emerging safety issue is confirmed.

The RMP should be assigned a new RMP version number and a date each time it is updated and submitted for assessment.

An updated RMP can be submitted as a standalone [currently C.I.11] variation, when necessary, but it is most often submitted as a consequence of or part of another variation.

The format and content of the RMP should follow the RMP template; Guidance on the format of the risk management plan (RMP) in the EU – in integrated format which consists of seven parts.

For a generic medicinal product, hybrid products and/or fixed combination products with no new active substance the safety concerns should be aligned to those of the originator product that are available;

  • either from the originator’s approved RMP
  • or from the list of safety concerns of the substance published on the CMDh website.

RMPs are approved per each medicinal product, not per MAH, therefore only one RMP should be submitted for an MRP or DCP with different MAHs. The RMP must remain identical in RMS/all CMS throughout the product life cycle.

The RMP should be provided in eCTD section 1.8.2. To facilitate the assessment a ‘tracked changes’ version of the RMP, in Microsoft word, should also be provided in the ‘working-documents’ folder outside eCTD.

The QPPV’s actual signature or the evidence that the RMP was reviewed and approved by the QPPV should be included in the finalised approved version of the document; for eCTD submissions this would be the RMP submitted with the last eCTD sequence of the procedure (usually the closing sequence).

UK RMP: The MHRA states you can either submit a GB/UK RMP or use the approved EU RMP with the GB/UK specific annex attached. Further information of UK RMP can be found on the MHRA website and their Guidance note on good pharmacovigilance practices.

Feel free to contact us here at ERA to assist you with all things regulatory in Ireland, UK and across the EU.

We take the pain out of regulatory so that you can take your medicine to the next level.

Written by

Fiona Downey

Fiona Downey 1

Fiona Downey 1

When will DADI application forms replace the current eAFs?

The electronic application forms (eAFs) we are familiar with are in the process of being replaced later this year by a web based digital application form in a new eAF portal. The new eAF portal will look somewhat similar to the current IRIS portal.

This project, known as DADI (Digital Application Dataset Integration), is intended to be used for both CAP (Centrally Authorised Products) & NAP (Nationally Authorised Products) applications to make the future of form-filling and submission-handling more efficient at an EU level.

The Human medicinal product Variation application form will be the first to go live in DADI format. Every person involved in drafting an eAF will need to have an EMA account and user access. Companies who use consultants to prepare eAFs will need to make sure that they assign an EMA role to the consultant.

The next stages of DADI will cover the

  • Veterinary variation application form
  • Initial MAA form for Human and Veterinary products
  • Renewal form for Human and Veterinary products

 How will it work?

  1. The eAF will be filled in using the new eAF portal (via user interface).
  2. The user will then finalise the eAF by generating a PDF rendition
  3. This PDF version must still be included in the eCTD submission, as before.
  4. It will not be possible to submit the form directly from the eAF portal

 When will it happen?

As outlined in the EMA roadmap (link provided below) the two immediate key deliverables are as follows:

Key deliverables Go-Live Time Lines
Year Quarter
Launch of Human variations web-form (parallel use of old and new variation forms as part of a Transition period) 2022 Q4 (October)
Use of variation web form only 2023 Q2 (April)

It is important for all industry stake-holders to keep up to date with the development of these new web-based forms by consulting the EMA website for updates at the various launch stages.

Where can I find information?

  • DADI Network Project Webinar – 18/01/2022 – Live broadcast is available here.
  • The updated DADI roadmap, including key milestones, is available here.
  • The updated version of the DADI Questions and Answers documents is available here.
  • The “Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF”documents are available in the following link.

The project will be implemented in phases, through a set of projects known as SPOR (Substances, Products, Organisations and Referentials) data management services for Human products. The Union Product Database will be the source of data for Veterinary products.

What is SPOR?

SPOR datasets Description of data types Status
Substance Management Services (SMS) Harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product. Under Development
Product Management Services (PMS) Harmonised data and definitions to uniquely identify a medicinal product based on regulated information (e.g. marketing authorisation, packaging and medicinal information). Under Development
Organisations Management Services (OMS) Data comprising organisation name and location address, for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers. Operational
Referentials Management Services (RMS) List of terms (controlled vocabularies) to describe attributes of products, e.g. lists of dosage forms, units of measurement and routes of administration. Operational

Once the above PMS and SMS are in place, pharmaceutical companies should start preparing to replace their current data submission format in Article 57 Database from the eXtended EudraVigilance Product Report Message (XEVPRM) format to the new ISO IDMP compatible format (HL7 FHIR). Webinars and training will be provided by EMA in due course.

 What do Marketing Authorisation Holders have to do at this stage?

  • Marketing authorisation holders need to check their data in SPOR (OMS) to ensure it is accurate and up to date. For CAPs the use of OMS data in the current eAF is already mandatory.
  • Marketing authorisation holders with authorised MA(s) need to check their data in Article 57 database (xEVMPD) to ensure it is accurate and up to date.

 Should you need any support at this stage in getting ready for the new Application Form format please feel free to contact us & the Ivowen team will be here to help.

Written by Marian Winder

marian 150x150 1

2019 – What a year

Ivowen attended the Medicines for Europe conference in January (Regulatory and Pharmacovigilance), the annual EuDRAcon conference in May, exhibited at TOPRA in October and joined our clients from around the world at CPhI in November.

We all saw Brexit come and go, Twice !! We wait to see what lies in store for the next deadline in January 2020.

The FMD came into effect across Europe in February in most member states.

Bulgaria joined CESP, eCTD became mandatory for all human procedures, lots of new guidance was published (to keep us all on our toes) and Nitrosamines in medicinal products moved to the top of everyone’s agenda.

With the festive season now upon us and 2020 on the horizon, Ivowen are setting our sights on the year ahead.

We will be attending the Medicines for Europe conference in January 2020 (Regulatory and Pharmacovigilance) and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’. This is a great opportunity to ask those difficult questions that you just could not get a straight answer to in 2019, on the ever present grey areas of Regulatory procedures.

To help you to plan ahead here are some helpful updates, in brief, as full articles will be posted in 2020:

Falsified Medicines Directive – Where we are now:

  • Implemented on 9th Feb 2019 in all MS except Greece, Italy and Belgium
  • The European Commission has produced a video to explain more about the safety features.
  • The HPRA have extended the use and learn period, initially to Sep 2019 and extended it again to end on a phased basis starting from 31st January 2020.
  • The MHRA is also taking a pragmatic, flexible approach to how they enforce the new legal requirements.

Nitrosamines

 

Ivowen are here to assist you in 2020 and will continue to provide the top quality service you have come to expect from us.

For more information on Ivowen’s services and how we can help you, contact us.

Written by Alice D’Alton.

Alice Dalton

Need help with all the regulatory jargon?

Check out our updated GLOSSARY OF ABBREVIATIONS AND ACRONYMS.

Read More

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