Abstract
There is no international norm-setting mechanism for pharmaceutical registration. By contrast, the International Commission on Radiological Protection (ICRP) has been recommending widely respected norms for X-rays and radioactive isotopes in medical and other uses for almost a century. It does so with no legal authority on the basis of collaborative deliberations by a self-selected group that includes experts concerned about both health effects and the benefits of ionizing radiation. Such an “epistemic group” has advantages over the more usual adversarial processes. It can evaluate the scientific evidence more objectively, it can adapt more rapidly to technological progress, and it can judge benefits as well as risks. Forming such normative epistemic groups for at least some of the rapidly growing number of new pharmaceuticals would avoid duplication and contribute to harmonizing pharmaceutical registration worldwide.