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EMA Concept Paper: Revision of the Guideline on Similar Biological Medicinal Products
Biosimilar medicines have become an integral part of modern healthcare by expanding patient access to biological therapies while maintaining high standards of quality, safety, and efficacy. As scientific knowledge, analytical technologies, and regulatory frameworks continue to evolve, regulatory guidance must also adapt to reflect these advancements. The Concept Paper on Revision of the Guideline on Similar Biological Medicinal Products sets out the European Medicines Agency'
Sharan Murugan
Jul 263 min read
Pakistan's DRAP: Guidelines for Good Cold Chain Management Practices
Pakistan's Drug Regulatory Authority of Pakistan released Draft Guidelines for "Good Cold Chain Management Practices for...
Sharan Murugan
Mar 28, 20231 min read
Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...
Sharan Murugan
Nov 23, 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...
Sharan Murugan
Oct 27, 20221 min read