{"abstract":"The Food and Drug Administration (FDA) is proposing to amend its pre- and postmarketing safety reporting regulations for human drug and biological products to implement definitions and reporting formats and standards recommended by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and by the World Health Organization's (WHO's) Council for International Organizations of Medical Sciences (CIOMS); codify the agency's expectations for timely acquisition, evaluation, and submission of relevant safety information for marketed drugs and licensed biological products; require that certain information, such as domestic reports of medication errors, be submitted to the agency in an expedited manner; clarify certain requirements; and make other minor revisions. FDA is also proposing to amend its postmarketing annual reporting regulations for human drug and licensed biological products by revising the content for these reports. FDA is taking this action to strengthen its ability to monitor the safety of human drugs and biological products. The intended effect of these changes is to further worldwide consistency in the collection of safety information and submission of safety reports, increase the quality of safety reports, expedite FDA's review of critical safety information, and enable the agency to protect and promote public health. These proposed changes would be an important step toward global harmonization of safety reporting requirements and additional efforts are underway within the Department of Health and Human Services to harmonize the reporting requirements of U.S. Federal agencies (e.g., FDA and the National Institutes of Health (NIH) are continuing to work together to address the best ways to streamline information sharing and harmonize, to the extent possible, the safety reporting requirements of the two agencies).","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2003/03/14/03-5204.html","cfr_references":[{"chapter":null,"citation_url":null,"part":310,"title":21},{"chapter":null,"citation_url":null,"part":312,"title":21},{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":320,"title":21},{"chapter":null,"citation_url":null,"part":600,"title":21},{"chapter":null,"citation_url":null,"part":601,"title":21},{"chapter":null,"citation_url":null,"part":606,"title":21}],"citation":"68 FR 12406","comment_url":null,"comments_close_on":"2003-07-14","correction_of":null,"corrections":[],"dates":"Submit written comments by July 14, 2003. Submit written comments on the collection of information by April 14, 2003.","disposition_notes":null,"docket_ids":["Docket No. 00N-1484"],"dockets":[],"document_number":"03-5204","effective_on":null,"end_page":12497,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/03/14/03-5204.xml","html_url":"https://www.federalregister.gov/documents/2003/03/14/03-5204/safety-reporting-requirements-for-human-drug-and-biological-products","images":{"EP14MR03.000":{"large":"https://img.federalregister.gov/EP14MR03.000/EP14MR03.000_large.png","medium":"https://img.federalregister.gov/EP14MR03.000/EP14MR03.000_medium.png","original_size":"https://img.federalregister.gov/EP14MR03.000/EP14MR03.000_original_size.png"}},"images_metadata":{"EP14MR03.000":{"large":{"identifier":"EP14MR03.000","content_type":"image/png","size":110082,"width":823,"sha":"34d2854d94e18db947708b2129270785","url":"https://img.federalregister.gov/EP14MR03.000/EP14MR03.000_large.png","height":1051},"medium":{"identifier":"EP14MR03.000","content_type":"image/png","size":64598,"width":574,"sha":"d60260c1d1b016f0c48514a2154e2cc6","url":"https://img.federalregister.gov/EP14MR03.000/EP14MR03.000_medium.png","height":733},"original_size":{"identifier":"EP14MR03.000","content_type":"image/png","size":489338,"width":4534,"sha":"91f6ee6c0951287fb7a069a15f15e256","url":"https://img.federalregister.gov/EP14MR03.000/EP14MR03.000_original_size.png","height":5791}}},"json_url":"https://www.federalregister.gov/api/v1/documents/03-5204?publication_date=2003-03-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-03-14/03-5204/mods.xml","not_received_for_publication":null,"page_length":92,"page_views":{"count":9729,"last_updated":"2026-10-24 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-03-14/pdf/03-5204.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-03-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/03/14/03-5204.txt","regulation_id_number_info":{"0910-AA97":{"issue":"202004","html_url":"https://www.federalregister.gov/regulations/0910-AA97/postmarketing-safety-reporting-requirements-for-human-drug-and-biological-products","title":"Postmarketing Safety Reporting Requirements for Human Drug and Biological Products","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202004&RIN=0910-AA97&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AA97"],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":12406,"subtype":null,"title":"Safety Reporting Requirements for Human Drug and Biological Products","toc_doc":"Pre- and postmarketing  safety reporting requirements","toc_subject":"Human drugs and biological products:","topics":["Administrative practice and procedure","Biologics","Blood","Confidential business information","Drugs","Exports","Imports","Investigations","Labeling","Laboratories","Medical devices","Medical research","Reporting and recordkeeping requirements","Safety"],"type":"Proposed Rule","volume":68}