Use of the Multi-State Procedure for Variations of Dosage Forms

In 1987, Du Pont Pharma submitted its first multi-state application for a product named Brevibloc. The two-step application began with submission in France for a concentrated dosage form. Two years later, the company applied for a variation on a diluted dosage form. Initially, no common decision was agreed upon, and a quality working party was assembled to sort out the conditions of approval. Du Pont Pharma found that the multi-state procedure can be a fast track in certain countries, but encountered problems with nonbinding CPMP opinions.