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EMA Guidance: Core SmPC Guideline for Subcutaneous and Intramuscular Immunoglobulins: What Manufacturers Need to Know
Human normal immunoglobulin (IgG) products administered via the subcutaneous (SCIg) or intramuscular (IMIg) route are essential...

Sharan Murugan
Jun 5, 20252 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...

Sharan Murugan
Nov 30, 20242 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...

Sharan Murugan
Jan 13, 20241 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...

Sharan Murugan
Oct 27, 20221 min read
