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1.Feature image Regulatory Guidance Updates, 08 01 25

Regulatory Guidance updates in February 2026

3rd March 2026

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

Regulatory Guidance updates in January 2026

30th January 2026

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

Regulatory Guidance updates in March and April 2026

8th May 2026

Did you know that the following Regulatory Guidance was updated in March and April 2026?

HPRA (IE):

HPRA guidance issued in relation to EMA list of ingredients restricted or prohibited for use in cosmetics from 1st May 2026
CTCG Guidance and Webinar: New Article 11 Workaround for Clinical Trials:
- The Clinical Trials Coordination Group (CTCG) has published guidance for sponsors on a new workaround for Article 11 of the Clinical Trial Regulation (Regulation (EU) No 536/2014). This approach will apply from 27 April 2026.

MHRA (UK):

Apply for a licence to market a medicine
- Updated guidance on electronic submissions to the MHRA
MHRA Portal: register to submit forms
- Updated guidance to add MHRA Portal registration form
Medicines licensing: how to apply
- Updated guidance on varying, renewing and transferring ownership of a marketing authorisation were added
Clinical trials for medicines: notifiable trials.
- Updated guidance on ‘Applications that need expert advice’ to change timeline from 14 days to 28 days
- Addition of the Confirmation of Notifiable Trial Criteria form and clarification that IND refers to investigational new drug (no change note needed)
- The amended Clinical Trials Regulations took full effect on 28 April 2026
  - As such, this guidance should now be considered effective and is no longer in draft

EMA (EU wide):

As always the EMA regularly updates their website – here are some of the highlights from March and April 2026.

Medicines – Human:
- A Q&A clinic on the eAF took place on the 9^th March 2026
  - the slides from this session can be found on the EMA website.
  - The updated Variation Regulation Classification Guideline has been made available in both the interactive pdf eAF 28.0.0and in the PLM Portal web-based variation form January 2026 version.
  - Users are reminded to verify the accuracy and content of the selected scopes (including the conditions and documentation), before submitting the form to the relevant health authorities.
  - The EMA will introduce mandatory use for CAPs as of 1 September 2026.

- Updated pre-authorisation guidance
- Updated post-authorisation guidance
- Updated guidance on Mobile scanning and other technologies in the labelling and/or package leaflet of centrally authorised medicinal products
- Updated validation checklist for initial marketing authorisation applications – biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)
- Updated Product Management Service (PMS) – Frequently Asked Questions (FAQs)

Medicines – Veterinary:
- Updated guidance on variations not requiring assessment (veterinary medicines)
- Updated guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
- Updated guidance on transferring a veterinary marketing authorisation
- Updated pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6); Question 2.1.5 in “Preparing the dossier” section
- Updated QRD veterinary Appendix I – Adverse event (PhV) MSs reporting details

CMDh (MRP/DCP):

Updated “Examples for acceptable and not acceptable groupings for MRP/DCP products” to reflect the possibility of accepting the grouping of related Type IA and Type IAIN variations outside the annual update
Updated “Chapter 1 – CMDh Best Practice Guide for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharing” to clarify the allocation of procedure numbers for annual update of Type IA variations
Updated “Chapter 6 – CMDh BPG for the Processing of (Super-) Grouped Applications in the Mutual Recognition Procedure” to reflect the agreement on the possibility of accepting the grouping of related Type IA and Type IAIN variations outside the annual update
Updated Questions and answers on the Paediatric Regulation to reflect update to align with the new EC guidelines on the details of the various categories of variations and operation of the procedures
Updated “Best Practice Guide for Article 45 and 46 – Paediatric Regulation – EU Worksharing Procedure” to align with the new EC guidelines on the details of the various categories of variations and operation of the procedures. Other clarification updates were included

eSubmissions:

Mandatory Use of PLM Web-Based eAF for CAPs: To continue advancing the adoption of the PLM web-based eAF, the EMA will introduce mandatory use for CAPs as of 1 September 2026.
EU eCTD v4.0 validation criteria v1.1 published. eCTD v4.0 tool vendors may now begin implementing the new rules, and the updated validation criteria will become applicable starting 15 July 2026.

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

Marian Winder 1

Tag Archive for: Regulatory Guidance

Regulatory Guidance updates in February 2026

Regulatory Guidance updates in January 2026

Regulatory Guidance updates in March and April 2026

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