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Jan 131 min read

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...

Feb 27, 20231 min read

EMA Procedural Advice: Recommendations on Unforeseen Variations

Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen...

Aug 30, 20221 min read

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...