Were you aware that the following Regulatory Guidance was updated in January 2026?

 

HPRA (IE): 

• Updated fee guidance document for Human medicinal products

MHRA (UK): 

The MHRA have been very busy updating their website in January – here are some of the highlights

• Medicines: International Recognition Procedure
  • Updated dates indicating the submission deadlines for IRP Route B applications in the IRP Guidance page
• Medicines: Apply for a variation to your Marketing Authorisation
  • Updated to add new section on Type II variations – ‘Variations to add a new therapeutic indication’
• Medicines: Statement on new review of paracetamol safety during pregnancy
  • Paracetamol should be taken as directed in the patient information leaflet
• Medicines: that you can export from the UK or hoard
  • Updated to add: Aspirin (strength: all; pharmaceutical form: all); and Ifosfamide (strength: 1g/2g; pharmaceutical form: powder for solution for injection vials)
• Medicines: get scientific advice from MHRA
  • Removed info box at the top of the page as out of date
• Human and Veterinary: Register of licensed manufacturing sites
  • Updated to add the MS and MANSA registers for January 2026
• Updates to the Orphan Register
• Early Access to Medicines Scheme: Overview
  • Updated scientific opinion dates for EAMS 2026
• Clinical Trials: apply for authorisation in the UK
  • Updated to provide link and information under ‘Combined review of an investigative medicinal product and medical device – IMP+Device’
• Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessment and agile regulation
• Borderline products: how to tell if your product is a medicine
  • Updated to add Statistics table for May-October 2025

EMA (EU wide)

As always, the EMA regularly update their website – here are some of the highlights from January

• EMA post-authorisation guidance – updated
• Dates of 2026 Scientific Advice meetings and submission deadlines
• Medicines: Use of Paracetamol during pregnancy unchanged in the EU
  • Recent publication confirms no increased risk of autism, ADHD or intellectual disability
• EMA and FDA set common principles for AI in medicine development
• IRIS guide for applicants – updated
• Meeting highlights from Pharmacovigilance Risk Assessment Committee (PRAC)
• Meeting highlights from Committee for Veterinary Medicinal Products (CVMP)
• Published the Annual report of the Good Clinical Practice (GCP) Inspectors working group 2024
• Q&A about the clinical study data proof-of-concept pilot for industry – published
• One Health Approach
  • updated to include ‘One Health task force‘ section
• Q&A clinic: New Variation classification in eAF (recording available)
• 3 year rolling work plan for the Quality Innovation Group (QIG)

CMDH (MRP/DCP):

• Updated ‘contact points’ excel
  • This excel provides names, email addresses and phone numbers for seeking advice from each member state in the EU/UK for regulatory procedures
• National recommendations for requests to act as RMS – updated
• Recommendation for classification of unforeseen variations according to Article 5 – corrected
• ASMF workshare procedure user guidance – updated

eSubmissions:

• Updated PLM Portal eAF release notes
• European Shortages Monitoring Platform (ESMP)
  • Expanding to include: new tools and features to better support stakeholders in preventing, managing and mitigating medicine shortages
• Updated Variation Regulation Classification Guideline
  • has been made available in the interactive pdf eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version
• Go-Live announcement for EU eCTD v4.0 optional use for Centralised Procedure new MAAs

 

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 Alice D’Alton