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 19^th 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: 8^th 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