TITLE: EMA Publishes UPD Registration Guide for UI & API Users
DATE: 02-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) released an updated Union Product Database (UPD) registration guide to support UI and API users. The document outlines the full registration process, including EMA Account Management, organisation registration in OMS, and role-based access requirements for competent authorities, industry, and public users seeking restricted UPD access.
REFERENCE: https://www.ema.europa.eu/en/documents/other/upd-registration-guide-ui-api-users_en.pdf
TITLE: EMA Releases Recommended Submission Dates for Veterinary Medicinal Products
DATE: 02-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) published updated guidance on recommended submission dates for applications related to veterinary medicinal products. This document provides timelines and procedural expectations to support sponsors in planning their submissions under the relevant regulatory framework.
REFERENCE: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/recommended-submission-dates-veterinary-medicinal-products_en.pdf
TITLE: EMA Publishes Reflection Paper on Qualification of Non-Mutagenic Impurities
DATE: 02-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) released a reflection paper addressing approaches to the qualification of non-mutagenic impurities in medicinal products. This scientific guideline aims to support consistent assessment strategies and encourage harmonisation in impurity evaluation across regulatory submissions.
REFERENCE: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-qualification-non-mutagenic-impurities_en.pdf
TITLE: EMA Publishes List of CECP Opinions for Medical Devices Awaiting Conformity Assessment
DATE: 03-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) issued a list of Clinical Evaluation Consultation Procedure (CECP) opinions for medical devices that are currently awaiting finalisation of conformity assessment. This document supports transparency on CECP outcomes and informs stakeholders on devices under review.
REFERENCE: https://www.ema.europa.eu/en/documents/other/list-clinical-evaluation-consultation-procedure-cecp-opinions-issued-medical-devices-awaiting-finalisation-conformity-assessment_en.pdf
TITLE: EMA Publishes Q&A on Plasma Master File (PMF) Requirements for PMF Holders
DATE: 04-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) released a questions and answers (Q&A) document detailing requirements for Plasma Master File (PMF) holders. The guidance clarifies procedural and regulatory expectations to support compliance for organisations managing PMFs under the applicable regulatory framework.
REFERENCE: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/plasma-master-file-pmf-requirements-questions-answers-pmf-holders_en.pdf
TITLE: EMA Publishes Template for PRAC Assessment Report for Non-Interventional Post-Authorisation Studies
DATE: 04-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) released a template form for the PRAC assessment report related to non-interventional post-authorisation studies (PASS). This template aims to standardise reporting and improve clarity for final study rejports submitted for regulatory evaluation.
REFERENCE: https://www.ema.europa.eu/en/documents/template-form/template-prac-assessment-report-non-interventional-imposed-pass-final-study-report_en.docx
TITLE: EMA Publishes Start of Procedure List for Type II Variations & Extensions of Indication
DATE: 04-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) released a start of procedure report for Type II variations and extension of indication procedures under evaluation by the CHMP between 12 December 2025 and 29 January 2026. This Exjcel report offers stakeholders insight into ongoing variation assessments and regulatory activity.
REFERENCE: https://www.ema.europa.eu/en/documents/report/start-procedure-type-ii-variation-extension-indication-under-evaluation-chmp-12-december-2025-29-january-2026_en.xlsx
TITLE: EMA Publishes Data Protection Notice for EudraVigilance Human (EV-H)
DATE: 05-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) issued an updated data protection notice for the EudraVigilance Human (EV-H) system, outlining how personal data is processed and protected within the pharmacovigilance database. This document supports transparency and compliance with data protection requirements for stakeholders accessing EV-H data.
REFERNCE: https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-data-protection-notice-eudravigilance-human-ev_en.pdf
TITLE: EMA Releases Report on New Human Medicines Under Evaluation – February 2026
DATE: 05-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) published the applications report listing new human medicines currently under evaluation as of February 2026. This Excel report provides stakeholders with insights into the latest human medicinal product applications undergoing assessment.
REFERNCE: https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-february-2026_en.xlsx
TITLE: EMA Publishes PSUSA List for Tranexamic Acid (Nationally Authorised Products)
DATE: 06-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) released a PSUSA list for Tranexamic Acid, detailing nationally authorised medicinal products across EU member states. This document supports regulatory transparency and harmonises product information across markets.
REFERENCE: https://www.ema.europa.eu/en/documents/psusa/tranexamic-acid-list-nationally-authorised-medicinal-products-psusa-00003006-202503_en.pdf
TITLE: EMA Updates GVP Introductory Cover Note on Exposure of Pregnant/Breastfeeding Women and Children
DATE: 06-Feb-2026
DESCRIPTION: The European Medicines Agency (EMA) released an updated Good Pharmacovigilance Practices (GVP) introductory cover note, focusing on considerations for pregnant and breastfeeding women and their children exposed in utero or via breastmilk. This guideline enhances pharmacovigilance clarity around vulnerable populations in safety reporting.
REFERENCE: https://www.ema.europa.eu/en/documents/scientific-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-final-considerations-pregnant-breastfeeding-women-their-children-exposed-utero-or-breastmilk_en.pdf