Collaboration between Australia and Sweden in Drug Regulation

Abstract

A Memorandum of Understanding between Australia and Sweden, signed in February 1989 is the basis for a collaborative program in drug regulation between these countries. Under this agreement, priority has been given to the collaborative review of new chemical entities by exchanging evaluation reports between the two Agencies. Approximately 80% of pharmaceutical companies for which the Memorandum of Understanding had potential value gave their unconditional commitment to the program. Up to November 1989, Sweden received 21 reports on 12 applications and finalized the review of eight new chemical entities. The mean review time of 8 months is significantly shorter than the review times for applications not using the collaborative program. Australian reports have contributed 50% of the work required to review these applications with an estimated saving of $10–15,000 (Australian) per application. Australia has received 7 reports on 6 applications with one decision finalized