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 19^th 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