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Sep 30, 20222 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...

Sep 27, 20221 min read

EMA Guidance: Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources

Earlier today (27-September-2022) EMA released draft guidance on the "Good Practice Guide for the use of the Metadata Catalogue of...

Aug 12, 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...

Jul 26, 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...

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...

May 26, 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...