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 a reference product. The selection is made variably at national level by the drug regulatory authority having regard either to the most widely used “leading” product within the market or the pharmaceutical product that was first to be approved within that market. The possibility exists for significant differences to emerge between reference products adopted in different countries.
This being so, consideration needs to be given to the feasibility of developing reference materials 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 with defined quality and bioavailability characteristics.