SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the ( printed page 9909) preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).

The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area.

In the Federal Register of October 20, 2011 (76 FR 65199), FDA published a notice announcing the availability of a draft guidance entitled “E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide—Data Elements and Message Specification” and an appendix to the guidance entitled “ICSRs: Appendix to the Implementation Guide—Backwards and Forwards Compatibility.” FDA also published a correction notice (November 16, 2011, 76 FR 71044) giving interested persons an opportunity to submit comments by January 18, 2012.

After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in November 2012.

The guidance provides guidance on the data elements, terminology, and exchange standards for the submission of ICSRs to improve the inherent quality of adverse event data and enable improved handling and analysis of ICSRs. The E2B(R3) implementation guidance provides support for the implementation of software tools for creating, editing, sending, and receiving electronic ICSR messages. The E2B(R3) implementation guidance also provides instruction for how pharmaceutical industries and regulatory authorities should use the “International Organization for Standardization (ISO) 27953-2 (Part 2)” ICSR messaging standard for exchanging pharmacovigilance information among ICH regions and in other countries adopting ICH guidelines. The BFC appendix describes the relationship between data elements from E2B(R2) and E2B(R3) and is intended to assist reporters and recipients in implementing systems with special focus on the recommendations for converting back and forth between E2B(R2) and E2B(R3) ICSR reports. The E2B(R3) implementation guidance and BFC appendix are being issued as a package that includes schema files and additional technical information to be used for creating compliant ICSR files.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES ). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

Persons with access to the Internet may obtain the document at http://www.regulations.gov, http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm, or http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm.