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EMA Guidance: Scientific Guidelines with Summary of Product Characteristics (SmPC) Recommendations
The European Medicines Agency (EMA) Â has released a comprehensive document " Scientific guidelines with summary-of-product-characteristi...

Sharan Murugan
Nov 30, 20242 min read
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EMA: Guidance on Paediatric Submissions & Scientific Guidelines with SmPC Recommendations
Developing drugs specifically for paediatric use comes with its own set of challenges, including ethical considerations, appropriate...

Sharan Murugan
Jan 13, 20241 min read
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EMA Procedural Advice: Recommendations on Unforeseen Variations
Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen...

Sharan Murugan
Feb 27, 20231 min read
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Health Canada Recommendations: ICH Q3D(R2) Guideline for Elemental Impurities
Yesterday (29-August-2022) Health Canada notified that Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized...

Sharan Murugan
Aug 30, 20221 min read
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