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!
- 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.
- Updated guidance on “Guidance on pharmacovigilance procedures”
- Added further information on EURD list under section 5.2 of guidance
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:
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- EMA risk management information day: 8th September 2026
- Update to “Guidance published by Member States on the implementation of the Falsified Medicines Directive”
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
- The new version brings a minor change, affecting the substances dropdown in section 2.6.1.
