Current status of the international comparator (reference) product system

Since 1993, WHO's Division of Drug Management and Policies has been working with drug regulatory authorities from some 20 countries, the pharmaceutical industry--including both research-based as well as generic industry--and academia to set up requirements and specifications for multisource (generic) pharmaceutical products (1). One important area has been the development of an international list of comparator (reference) products for equivalence testing. This has become increasingly necessary as the manufacture, regulatory approvals and use of the generic pharmaceutical products have increased world-wide. In order to save time and resources in product development and to avoid duplication of unnecessary bioavailability testing in humans, it has been suggested that an internationally agreed comparator product system would be helpful. Moreover, any exposure of a human being to a pharmaceutical product in equivalence testing may carry a health risk and may consequently be considered unethical.