CMDH guidance Archives | European Regulatory Affairs Specialists

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

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

Fiona Downey

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

Alice Dalton 1

Tag Archive for: CMDH guidance

Regulatory Guidance updates in February 2026

Regulatory Guidance updates in January 2026

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