Viscoelastic Substances — Regulatory Aspects from the Industry Point of View

Abstract

During the morning session we have had an opportunity to see how varied and interesting are the uses of viscoelastic materials. No less varied is the story of their registration. From 1979 when Healon®, manufactured by the Swedish company Pharmacia AB, received marketing authorisation in the United States, until today when at least six other viscoelastic products have been approved or are in the process of registration worldwide, both the regulatory authorities and industry displayed a considerable hesitation as to what the viscoelastic products were from the standpoint of regulatory classification. In the following, I would like to illustrate this statement by briefly outlining how Healon® came to its marketing approvals and what provided the basis for regulatory decisions in various European and non-European countries. Finally, I shall briefly describe the regulatory status of viscoelastic products which followed in the steps of Healon® as far as this status is known to me.