Concertation Procedure for Variations of Biotech Products

Abstract

For many years, there were no clear guidelines for registering variations—new indications, new dosage regimens, new strengths, or new pharmaceutical formulations—for biotech products. In 1989, F. Hoffmann-LaRoche had a product—Roferon-A—which was approved for different indications in different Member States. In order to work toward harmonization as well as approval for new indications, we began to piece together information from BIRA, BGA, MCA, and CPMP. In April 1990, we began the concertation procedure for one variation (a new indication) of Roferon-A; since then we have successfully completed others, both new indications as well as harmonizations. By 1993, we hope to have a harmonized summary of product characteristics.