Regulatory Blog

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

Therapeutic equivalence is an important consideration when evaluating multisource prescription drug products and their potential substitution. The U.S. Food and Drug Administration (FDA) uses therapeutic equivalence evaluations to determine whether certain approved drug products can be expected to have the same clinical effect and safety profile when used under the conditions specified in their labeling. The FDA has issued the Guidance for Industry: Evaluation of Therapeutic