(1997; 248 pages) [French]
Part Seven. Choice of reference product
The innovator pharmaceutical product is usually the most logical reference product for related generics because, in general, its quality will have been well assessed and its efficacy and safety will have been securely established in clinical trials and post-marketing monitoring schemes. There is, however, currently no global agreement on the selection of reference products, which are selected at national level by the drug regulatory authority. Either the most widely used “leading” pharmaceutical product in the market or the product that was first approved in that market is normally chosen. It is therefore possible that significant differences may exist between the reference products adopted in different countries.
This being so, consideration needs to be given to the feasibility of developing reference products on a global basis. Representative bodies of the pharmaceutical industry and other interested parties should be invited to collaborate in the preparation, maintenance and international acceptance of a system of international reference standards for pharmaceutical products of defined quality and bioavailability.