Regulatory Guidance updates from 1st September to 9th October 2026

 

Regulatory Guidance updates 1^st September to 9^th October 2026 – ERA have tracked them for you!

HPRA (IE):

• HPRA Strategic Plan 2026–2029 sets out priorities & direction for the next four years
• HPRA has arranged a MedSafety Week to take place between the 2–8 November 2026
• International Coalition of Medicines Regulatory Authorities (ICMRA) has issued a statement on implementing alternative methods to animal testing for human medicines
  • ICMRA notes that scientific developments in recent years suggest that regulatory dependence on animal testing for human medicines can be reduced, provided that quality and patient safety are appropriately ensured. The statement encourages the development, validation, and adoption of non-animal-based testing methods for regulatory purposes where possible

MHRA (UK): 

• Updated guidance on “pharmacovigilance procedures”
  • Due to change in section 5 PSURs guidance
• Updated guidance on “Medicines: apply for a variation to your marketing authorisation”
  • clarified the assessment process for 120-day Type II variations for new therapeutic indications, including Day 90 decisions and the use of a single Request for Further Information (RFI). Clarified the applicants’ right to request CHM review following refusal of Type II variations
  • publication of guidance on Type IA annual update variations
  • clarified the assessment process for 120-day Type II variations for new therapeutic indications, including Day 90 decisions and the use of a single Request for Further Information (RFI). Clarified the applicants’ right to request CHM review following refusal of Type II variation
• Updated guidance on “Find product information about medicines”
  • published ‘UK Additional monitoring list for August 2026
• Updated guidance on Guidance Renewing marketing authorisations for medicines
  • Added a link to the new electronic Application Forms (eAFs) guidance page
• Updated guidance on “Medicines: apply for a variation to your marketing authorisation”
  • Added a link to the new electronic Application Forms (eAFs) guidance page
  • Added Appealing to CHM section which explains how to appeal to a Type II application refusal
• Updated guidance on “Apply for a licence to market a medicine in the UK”
  • Added a link to the new electronic Application Forms (eAFs) guidance page
  • Published guidance on “Electronic Application Forms (eAF) for UK medicines licensing applications”

EMA (EU wide):

Medicines – Human: 

• European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure updated:
  • Applicants should use the IRIS platform instead of raising a ticket for the following:
    • to notify of intended submission date of application
    • to notify of intended accelerated assessment request
    •  when submitting requesting pre-submission interactions, selecting submission type “Pre-submission interactions” rather than via the EMA Service Desk

• Electronic product information (ePI) submission during centralised procedures
  • Draft ePI implementation roadmap

 CMDh (MRP/DCP):

• Update to the “Compilation of links to guidance published by Members States on implementation of Falsified Medicines Directive” document
• Updated guidance to “Chapter 6 – CMDh Best Practice Guide for the processing of (super-)grouped applications in the Mutual Recognition Procedure”
  • Update to include option for individual type IA variation for preparation of MRP and line extension
• Updated guidance on the “Blue – Box” requirements”

eSubmissions:

• New version of the eSubmission Gateway XML delivery file to enable future inclusion of ePI details
  • From 2 October 2026, the eSubmission Gateway XML delivery file user interface will include an optional ePI (electronic product information) section, featuring a toggle and corresponding field for ePI selection.
  • This functionality is being introduced in preparation for the upcoming ePI go-live and will be used by applicants submitting ePI for centrally authorised products (CAPs)
  • For further information, please refer to the ePI go-live timelines and the guidance on declaring ePI details in centralised procedures
  • Additional communications regarding the ePI go-live for CAPs will be published through the relevant channels in due course.
• Veterinary MAA eAF v1.28.0.0 – minor version available
  • Minor version 1.28.0.0 of the interactive PDF electronic application form (eAF) for veterinary marketing authorisation application is available on the eAF website

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