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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 22, 20252 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 12, 20252 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 26, 20252 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
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
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
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
EMA Guidance: IRIS Guide for Applicants
On 03-June-2024 the European Medicines Agency released an updated "IRIS Guide for Applicants" that guides How to create, submit and...
Sharan Murugan
Jun 5, 20242 min read
EMA Guidance: EudraVigilance Registration Documents
The European Medicines Agency (EMA) on Thursday (16 May, 2024) released an updated guidance on "EudraVigilance Registration Documents"...
Sharan Murugan
May 18, 20242 min read
EMA: Guidance on the Anonymisation of PPD & Assessment of CCI during the preparation of RMPs
The European Medicines Agency (EMA) yesterday (26 April, 2024) released an updated guidance on the "Anonymisation of protected personal...
Sharan Murugan
Apr 27, 20242 min read
EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making
On 12 April 2024 the European Medicines Agency released "Guidance on real-world evidence provided by EMA: support for regulatory...
Sharan Murugan
Apr 16, 20242 min read
EMA: Guidance on the Pharmaceutical Quality of Inhalation & Nasal Medicinal Products
Yesterday (12 April 2024) the European Medicines Agency released new guidance on "The Pharmaceutical Quality of Inhalation & Nasal...
Sharan Murugan
Apr 13, 20242 min read
EMA Guidance: e-Submission of Information on IMP in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
The European Medicines Agency (EMA) last Wednesday released an updated guidance on the electronic submission of information on...
Sharan Murugan
Mar 25, 20242 min read
EMA: QRD updation and Product-Information Templates Updation
The European Medicines Agency released an updated template on QRD and updated its page on "Product-information templates - Human". The...
Sharan Murugan
Mar 2, 20242 min read