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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...

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...