Zdrowie i gospodarka · 05/11/1998

Electronic Reporting of Postmarketing Adverse Drug Reactions; Request for Comments

The Food and Drug Administration (FDA) is announcing that it is considering preparing a proposed rule that would require applicants, manufacturers, packers, and distributors of marketed human drugs and licensed biological products to submit postmarketing expedited individual case safety reports and individual case safety reports contained in periodic safety reports to the agency electronically using standardized medical terminology, data elements, and electronic transmission standards recommended by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The proposed rule would help harmonize reporting of postmarketing safety information worldwide and expedite detection of safety problems for marketed drugs, thus enhancing FDA's ability to protect and promote public health. FDA is soliciting comments from interested persons to assist with the development of the proposed rule. The agency is specifically seeking comments on whether exemptions from any electronic safety reporting requirements should be granted to any entity and, if so, the basis on which they should be granted, the cost benefits or burdens of suc