Regulatory Guidance updates in February 2026

Here are the main highlights of Regulatory Guidance updated in February 2026

HPRA (IE): 

The HPRA promoted the Facilitating and Accelerating Strategic Clinical Trials (FAST-EU).  FAST-EU is a pilot initiative aiming to accelerate the assessment and authorisation of clinical trials running in multiple EU/EEA countries. The pilot is currently open for submissions and is expected to run until early 2027.

MHRA (UK): 

The MHRA published a few updates:

• Medical devices regulations:
  • Targeted consultation on the indefinite recognition of CE marked devices in Great Britain.
• Addition of the latest Additional Monitoring List for Jan 2026
• New information on responsibilities and reporting on nitrosamine impurities

EMA (EU wide)

As always the EMA regularly updates their website – here are some of the highlights from February

• Medicines – Human:
  • Updated validation checklist for Type II variations
  • Concept paper on the revision of the guidelines on Good
    Manufacturing Practice for medicinal products – Annex 15
    – Qualification and Validation. Public consultation began on 09th February
  • ICH M15 Guideline on general principles for model-informed drug development, document updated
  • Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form, document updated
• Medicines – Veterinary:
  • Guideline on quality aspects of mRNA vaccines for veterinary use, Public consultation began in February
  • Question and answer on the information contained within section 4.2 of the SPC on pharmacodynamic properties for pharmaceutical products
• Annual fees payable to the EMA, page updated
• Reflection paper on the qualification of non-mutagenic impurities
• FAQ document published to address common queries and provide guidance on the European Shortages Monitoring Platform (ESMP)
• List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs) excel is updated
• List of contact information for the national competent authorities in the EEA page updated
• Updated PRAC report templates
• Guidance on Good Pharmacovigilance Practices (GVP) updated
• Summary from the industry stakeholder webinar on the revised guideline on the environmental risk assessment of medicinal products for human use
• The next eAF Q&A will be on the 9th of March

CMDH (MRP/DCP):

• Agenda for the 24-25 Feb Meeting
• Report from the CMDh meeting held on 27-28 January 2026
• Q&A – Generic Applications

eSubmissions:

• Updated PLM Portal eAF Release notes (version: 1.2.1.6 – Release date 16/02/2026)

For any support you might need to navigate the latest guidance or just for assistance with your procedure preparations, submissions, responses, etc., you can contact us on info@eureg.ie.

 

Written by Fiona Downey