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EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...
Sharan Murugan
Oct 13, 20221 min read
EMA Guidance: Checking process of Mock-ups & Specimens of Outer/Immediate Labelling & PI -CP
Earlier on 27th Spetmber, 2022 EMA revised and released their updated Regulatory and procedural guideline on "Checking process of...
Sharan Murugan
Sep 30, 20222 min read
IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
On 2-September, 2022 the European Medicines Agency released the updated IRIS guidance on "How to create and submit scientific...
Sharan Murugan
Sep 4, 20221 min read
EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...
Sharan Murugan
Sep 1, 20221 min read
EMA: Updated EudraVigilance Registration Manual
EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been...
Sharan Murugan
Aug 25, 20221 min read
Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023
Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became...
Sharan Murugan
Aug 12, 20221 min read
EMA updated Guidance: IDMP Products Management Services - Implementation Guide
On 8 July 2022, EMA updated its Products Management Services - Implementation Guide "Implementation of International Organization for...
Sharan Murugan
Jul 31, 20221 min read
EMA Guidance: Prevention of Medicine Shortages in the EU
Recently EMA released new guidance for "patients and healthcare professionals’ organisations" with key principles and examples of good...
Sharan Murugan
Jul 26, 20221 min read
EMA: Plan for Digital Hub for the European Medicines Regulatory Network
A technology capability investment plan has been published by the European Medicines Agency (EMA), which outlines how it plans to invest...
Sharan Murugan
Jul 26, 20221 min read
EMA- New Guidance on Complex Clinical Trials
On 2 June, an official Q&A prepared by the European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies...
Sharan Murugan
Jun 7, 20221 min read
EMA - Guideline on Treatment of Bacterial Infections
European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that follow the guidelines of other...
Sharan Murugan
May 26, 20221 min read
EMA's IRIS Guide for Applicants - On How to Create & Submit Scientific Applications
Yesterday the European Medicines Agency released updated IRIS guidance on "How to create and submit scientific applications, for industry...
Sharan Murugan
May 17, 20221 min read
EMA Draft Guidance- How To Approach the Protection Clinical Trial Information System (CTIS)
On 7 April 2022, European Medicines Agency released a draft guidance document on how to approach the protection of personal data and...
Sharan Murugan
Apr 10, 20222 min read
EMA Guidance on Post-Authorisation Procedural Advice for CAP users & EudraVigilance Reg. Manual
On 18 March 2022, EMA released updated guidance on "European Medicines Agency post-authorisation procedural advice for users of the...
Sharan Murugan
Mar 23, 20221 min read
EMA Guidance on GVP for PPP & Parallel EMA/EUnetHTA 21 Consultation
Guideline on Good Pharmacovigilance Practices (GVP) for Pregnancy Prevention Programs A public consultation was launched by the European...
Sharan Murugan
Mar 23, 20222 min read
EU Guidelines for Good Manufacturing Practice for Medicinal Products
As part of the manufacturing import authorisation (MIA) process, the Annex outlines the GMP requirements that must be followed when...
Sharan Murugan
Mar 3, 20221 min read
EU Common Standard for electronic Pproduct Information
ePI refers to medicines' authorised, statutory information (including summary of product characteristics, package leaflet and labeling)...
Sharan Murugan
Mar 3, 20221 min read
EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance
This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have and...
Sharan Murugan
Jan 16, 20221 min read
Post-Authorisation Procedural Advice for Users of the Centralised Procedure – Updated guideline EMA
This guidance document addresses a number of questions that marketing authorisation holders (MAHs) may have on post-authorisation...
Sharan Murugan
Nov 14, 20211 min read
Updated Guideline on Registry-Based Studies (EMA)
This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support...
Sharan Murugan
Nov 7, 20211 min read