This Guideline is intended to provide internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post- marketing studies, and how such an approach would be implemented. By collecting selective safety data,  the burden to patients would be reduced, a larger number of informative clinical studies could be carried  out with greater efficiency, studies could be conducted with greater global participation, and the public  health would be better served.