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EMA Policy 0070 Guidance: Transparency in Clinical Data Publication – Version 1.5 (May 2025)

The European Medicines Agency (EMA) has long committed to this principle through Policy 0070, which governs the publication of clinical...

Sharan Murugan

May 173 min read

EMA Network Data Steering Group workplan 2025-2028: Leveraging Data and AI for Enhanced Medicine Regulation

In the evolving landscape of medicines regulation, data and artificial intelligence (AI) have become pivotal tools to enhance public and...

Sharan Murugan

May 113 min read

EMA Concept Paper: Advancements in Good Manufacturing Practice for Advanced Therapy Medicinal Products

The pharmaceutical industry continually evolves to adapt to new scientific discoveries and technological advancements. Good Manufacturing...

Sharan Murugan

May 113 min read

EMA Guidance: Anonymisation and Confidentiality in Risk Management Plans (RMPs)

The European Medicines Agency (EMA) has published a revised guideline titled " Guidance on the Anonymisation of Protected Personal Data...

Sharan Murugan

Apr 184 min read

EMA Guidance: Procedural Advice on Paediatric Applications

The European Medicines Agency (EMA) has issued updated guidance " Procedural advice on Paediatric Applications " to support stakeholders...

Sharan Murugan

Apr 183 min read

EMA Draft Guideline: Quality Aspects of mRNA Vaccines

The European Medicines Agency (EMA) has released a draft guideline outlining " Quality standards for mRNA Vaccines " , f ocusing on...

Sharan Murugan

Apr 82 min read

EMA's New AI Work Plan: Shaping the Future of Medicines Regulation

The European Medicines Agency (EMA) has unveiled a comprehensive Artificial Intelligence (AI) Work Plan to guide the integration of AI...

Sharan Murugan

Mar 312 min read

EMA User Guide: For Micro, Small, and Medium-Sized Enterprises (SMEs)

The European Medicines Agency (EMA) has released a " User Guide for Micro, Small, and Medium-Sized Enterprises (SMEs) " to help...

Sharan Murugan

Mar 182 min read

EMA IRIS Guide for Applicants: A Comprehensive Overview

The European Medicines Agency (EMA) has released the updated " IRIS Guide for Applicants , " which provides detailed instructions on how...

Sharan Murugan

Mar 153 min read

EMA Procedural Advice: Appointment of CHMP, CAT, and PRAC Rapporteurs and Co-Rapporteurs

The European Medicines Agency (EMA) has released an updated procedural guidance document on the " Appointment of CHMP, CAT, and PRAC...

Sharan Murugan

Feb 282 min read

EMA Concept Paper: Guideline on Mechanistic Models in Model-Informed Drug Development (MIDD)

The European Medicines Agency (EMA) has released a concept paper proposing the development of a guideline for the assessment and...

Sharan Murugan

Feb 222 min read

EMA Announcement: Regular Scientific Advice Procedure for High-Risk Medical Devices

In collaboration with the European Commission, the European Medicines Agency (EMA) has launched (10 February 2025) a regular...

Sharan Murugan

Feb 122 min read

EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation

The European Medicines Agency (EMA) provided detailed revised guidance "Procedural Advice for Orphan Medicinal Product Designation " for...

Sharan Murugan

Jan 262 min read

EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure

The European Medicines Agency (EMA) has issued comprehensive guidance " European Medicines Agency Pre-Authorisation Procedural Advice for...

Sharan Murugan

Dec 21, 20243 min read

MDCG Guidance: Implementation of the Master UDI-DI Solution for Contact Lenses

In November 2024, the Medical Device Coordination Group (MDCG) released " MDCG 2024-14 - Guidance on the implementation of the Master...

Sharan Murugan

Nov 30, 20242 min read

EMA Guidance: Scientific Guidelines with Summary of Product Characteristics (SmPC) Recommendations

The European Medicines Agency (EMA) has released a comprehensive document " Scientific guidelines with summary-of-product-characteristi...

Sharan Murugan

Nov 30, 20242 min read

EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025

The European Medicines Agency (EMA) has updated its page on the " Application of the Amended Variations Regulation from 1 January 2025 "...

Sharan Murugan

Nov 1, 20242 min read

EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products

The European Medicines Agency (EMA) recently updated the guideline on "Quality and Equivalence of Locally Applied, Locally Acting...

Sharan Murugan

Oct 6, 20242 min read

EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications

On 16 September 2024 the European Medicines Agency (EMA) provided a detailed guide " IRIS guide for applicants - How to create and submit...

Sharan Murugan

Sep 21, 20242 min read

EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)

The advancement of Artificial Intelligence (AI) is transforming many industries, and the pharmaceutical and regulatory sectors are no...

Sharan Murugan

Sep 15, 20242 min read