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EMA Policy 0070 Guidance: Transparency in Clinical Data Publication – Version 1.5 (May 2025)
The European Medicines Agency (EMA)Â has long committed to this principle through Policy 0070, which governs the publication of clinical...
Sharan Murugan
3 days ago3 min read
21 views
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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
23 views
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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
17 views
0 comments
EMA Guidance: Anonymisation and Confidentiality in Risk Management Plans (RMPs)
The European Medicines Agency (EMA)Â has published a revised guideline titled " Guidance on the Anonymisation of Protected Personal Data...
Sharan Murugan
Apr 184 min read
19 views
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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
12 views
0 comments
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
43 views
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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
33 views
0 comments
EMA User Guide: For Micro, Small, and Medium-Sized Enterprises (SMEs)
The European Medicines Agency (EMA)Â has released a " User Guide for Micro, Small, and Medium-Sized Enterprises (SMEs) "Â to help...
Sharan Murugan
Mar 182 min read
25 views
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EMA IRIS Guide for Applicants: A Comprehensive Overview
The European Medicines Agency (EMA)Â has released the updated " IRIS Guide for Applicants , " which provides detailed instructions on how...
Sharan Murugan
Mar 163 min read
47 views
0 comments
EMA Procedural Advice: Appointment of CHMP, CAT, and PRAC Rapporteurs and Co-Rapporteurs
The European Medicines Agency (EMA)Â has released an updated procedural guidance document on the " Appointment of CHMP, CAT, and PRAC...
Sharan Murugan
Mar 12 min read
45 views
0 comments
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
25 views
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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
13 views
0 comments
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
8 views
0 comments
EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure
The European Medicines Agency (EMA)Â has issued comprehensive guidance " European Medicines Agency Pre-Authorisation Procedural Advice for...
Sharan Murugan
Dec 21, 20243 min read
127 views
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MDCG Guidance: Implementation of the Master UDI-DI Solution for Contact Lenses
In November 2024, the Medical Device Coordination Group (MDCG) Â released " MDCG 2024-14 - Guidance on the implementation of the Master...
Sharan Murugan
Nov 30, 20242 min read
12 views
0 comments
EMA Guidance: Scientific Guidelines with Summary of Product Characteristics (SmPC) Recommendations
The European Medicines Agency (EMA) Â has released a comprehensive document " Scientific guidelines with summary-of-product-characteristi...
Sharan Murugan
Nov 30, 20242 min read
244 views
0 comments
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
167 views
0 comments
EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products
The European Medicines Agency (EMA)Â recently updated the guideline on "Quality and Equivalence of Locally Applied, Locally Acting...
Sharan Murugan
Oct 6, 20242 min read
93 views
0 comments
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
59 views
0 comments
EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
The advancement of Artificial Intelligence (AI) Â is transforming many industries, and the pharmaceutical and regulatory sectors are no...
Sharan Murugan
Sep 15, 20242 min read
24 views
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