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Earlier today (27-September-2022) EMA released draft guidance on the "Good Practice Guide for the use of the Metadata Catalogue of...

Sharan Murugan
Sep 27, 20221 min read
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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
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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
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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
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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
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