Regulacje i polityka gospodarcza · 27/10/1994

Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES

The Food and Drug Administration (FDA) is proposing to amend its current adverse experience reporting regulations for human drug products and for licensed biological products to provide consistency with the elements of FDA Form 3500A and require the use of this new reporting form; revise certain definitions and reporting periods and formats as recommended by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the World Health Organization's Council for International Organizations of Medical Sciences (CIOMS); require applicants or manufacturers, packers, and distributors to develop written procedures for monitoring and reporting adverse experiences; state that reports of adverse experiences that are forwarded by FDA to the applicant or manufacturer, packer, and distributor should not be resubmitted to the agency; and make other revisions to the regulations to provide uniformity in adverse experience reporting for human drug products and licensed biological products. These changes would simplify and facilitate the reporting of adverse experiences and would enhance agencywide consistency in the collection