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EMA Updates on Nasal Product Therapeutic Equivalence and Good Pharmacogenomic Practice
The European Medicines Agency (EMA) has published two important regulatory documents addressing pharmaceutical equivalence and pharmacogenomic practices. The draft Guideline on the requirements for demonstrating therapeutic equivalence for nasal products outlines the evidence needed to demonstrate equivalence between nasal medicines. The Concept paper on the guideline revision on good pharmacogenomic practice describes proposed updates to pharmacogenomic methodology, genetic
Sharan Murugan
Oct 115 min read
EMA Guideline on the Development, Manufacture of Synthetic Peptides and Good Pharmacogenomic Practice
Modern medicines development increasingly sits at the intersection of advanced chemistry and genomic science. On one hand, synthetic peptides represent a fast-growing therapeutic class that bridges small molecules and biologics. On the other, pharmacogenomics is reshaping how medicines are developed, evaluated, and ultimately used in patients. Recognising these parallel advances, the European Medicines Agency (EMA) has recently published two key scientific documents: the Guid
Sharan Murugan
Dec 13, 20253 min read