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FDA and The International Conference on Harmonization (ICH) initiatives of the EU, Japan and the US.

From CDER email news today:

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.

FDA recently announced in Federal Register notices the availability of draft guidances prepared under the auspices of the ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use.(1) Comments on them are most useful if submitted by November 3, 2008.
One of these four FDA Draft Guidances describes format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR would serve as a harmonized, annual clinical trial safety report that would be standard among the 3 ICH regions. DSUR is intended to promote a consistent approach to annual clinical safety reporting among ICH regions and enhance efficiency by reducing the number of reports generated for submission to regulatory authorities. Entitled, 'E2F Development Safety update Report' (dated June 5, 2008), here are a few excerpts:
The periodic analysis of safety information is crucial to ongoing assessment of risk to trial subjects during clinical development of an investigational drug. It is also important to notify regulatory and other interested parties (ie ethics commitees) at regular intervals of the evolving safety profile of an investigational drug and actions proposed or being taken to address safety issues. DSURs would be a common standard for annual clinical trial safety reporting in any ICH region....The main focus of the DSUR is data from interventional clinical trials of investigational drugs, including biologicals, with or without marketing approval whether conducted by commercial or non-commercial sponsors... DSUR data should be submitted no later than 60 calendar days from the DSUR data lock point--this date is based on the date of the sponsor's first authorization to conduct a clinical trial in any country (the 'Development International Birth Date', DIBD).

The Sponsor of a clinical trial is responsible for preparing the DSUR but many relationships/responsibilities typical in drug discovery/development research are discussed in terms of the proposed DSUR. For example, 'Shared Responsibilities' include situations where an individual clinical trial or drug development programme involves collaboration with public or private institutions , business partners or other parties and states that a written contract should be in place detailing responsibilities for preparation and submission of the DSUR. This requirement is applicable to situations where a sponsor delegates the preparation of the DSUR to a 3rd party (e.g. CRO)(2)
(1)http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17861.pdf(2)http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0386-gdl.pdf (26 pp + appendices)
See below the fold for who is involved in this particular ICH.

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; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the 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.

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This page contains a single entry from the blog posted on August 22, 2008 10:42 AM.

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