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Sharan Murugan
Nov 302 min read
EMA Guidance: Scientific Guidelines with Summary of Product Characteristics (SmPC) Recommendations
The European Medicines Agency (EMA) has released a comprehensive document " Scientific guidelines with summary-of-product-characteristi...
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Sharan Murugan
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...
84 views0 comments
Sharan Murugan
Oct 27, 20221 min read
DRAP Guidelines: Preparation of Summary of Product Characteristics (SmPC)
The Drug Regulatory Authority of Pakistan (DRAP) released a finalized guideline "Preparation of Summary of Product Characteristics...
16 views0 comments