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Earlier today (27-September-2022) EMA released draft guidance on the "Good Practice Guide for the use of the Metadata Catalogue of...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