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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
15 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
7 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
24 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
30 views
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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
21 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
35 views
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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
35 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
24 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
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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
7 views
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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
114 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
203 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
158 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
69 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
55 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
0 comments
EMA Guidance: EudraVigilance Registration Manual
Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...
Sharan Murugan
Jul 20, 20242 min read
38 views
0 comments
EMA Guidance: Proposed Amendments - Variations Categories and Procedures
The European Medicines Agency (EMA) has proposed amendments to the European Commission's "Guidelines on Variations Categories and...
Sharan Murugan
Jun 15, 20242 min read
155 views
0 comments
EMA Guidance: Procedural Advice on Paediatric Applications
The European Medicines Agency (EMA) yesterday(04 June 2024) updated and released the guidance document "Procedural Advice on Paediatric...
Sharan Murugan
Jun 5, 20242 min read
65 views
0 comments