Search
Sharan Murugan
Feb 82 min read
UK MHRA Guidance: Exceptions and Modifications to the EU Good Pharmacovigilance Practices (GVP) for UK MAHs
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on pharmacovigilance requirements that...
30 views0 comments
Sharan Murugan
Jan 262 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...
6 views0 comments
Sharan Murugan
Dec 21, 20243 min read
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...
63 views0 comments
Sharan Murugan
Nov 1, 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 "...
109 views0 comments
Sharan Murugan
Sep 21, 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...
44 views0 comments
Sharan Murugan
Jul 19, 20242 min read
EMA Guidance: EudraVigilance Registration Manual
Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...
26 views0 comments
Sharan Murugan
Jul 15, 20242 min read
New EU Regulations on AI in Medical Devices: Key Insights and Implications
The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...
84 views0 comments
Sharan Murugan
Jul 11, 20242 min read
EU Guidance: Procedural Advice on Paediatric Applications
The European Medicines Agency (EMA) provides detailed guidance "Procedural Advice on Paediatric Applications" that aims to facilitate the...
35 views0 comments
Sharan Murugan
Jul 10, 20242 min read
WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs
WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...
17 views0 comments
Sharan Murugan
Jul 5, 20242 min read
MDCG Med Dev Guidance: Standardisation for Medical Devices
The Medical Device Coordination Group recently updated the guidance"Standardisation for Medical Devices" include points on topics...
7 views0 comments
Sharan Murugan
Jun 5, 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...
55 views0 comments
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...
146 views0 comments
Sharan Murugan
May 17, 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"...
20 views0 comments
Sharan Murugan
Mar 2, 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...
160 views0 comments
Sharan Murugan
Feb 17, 20242 min read
EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD
Recently (14 February 2024) the European Medicines Agency released updated (annotated) guidance on "Guidance on the electronic submission...
95 views0 comments
Sharan Murugan
Jan 22, 20242 min read
EMA Guidance: Applying for Orphan Designation, IRIS Guide & Orphan Des Procedural Guidance & Forms
Recently (19 January 2023) the European Medicines Agency released an updated guidance on "IRIS guide for applicants - How to create and...
45 views0 comments
Sharan Murugan
Jul 4, 20232 min read
EMA Guideline: Notification of Serious Breaches or the Cinical Trial Protocol
Today (04 July 2023) the European Medicines Agency released a scientific guideline "Guideline for the notification of serious breaches of...
625 views0 comments
Sharan Murugan
Jun 27, 20231 min read
EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA
Today (27 June 2023), the European Medicines Agency released updated guidance on "Procedural Advice on Publication of Information on...
287 views0 comments
Sharan Murugan
May 18, 20231 min read
EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages
Earlier today (17 May 2023) the European Medicines Agency released an updated guidance document on "Good Practices for Industry for the...
51 views0 comments
Sharan Murugan
Apr 23, 20231 min read
EMA Guidance: IRIS guide to Registration and Research Product Identifiers
Last Week (20 April 2023) the European Medicines Agency updated and released the guidance on "IRIS guide to Registration and RPIs" which...
161 views0 comments