Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit electronic comments on the guidance to
Michelle Limoli, Office of International Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4480.
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 (EU), 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 (MHLW); 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.
Following changes made by the three pharmacopeias and after review of the changes by the ICH Q4B Expert Working Group, the ICH Steering Committee, with the endorsement of the three participating regulatory agencies, approved Q4B Annex 7(R2) in November 2010.
The guidance provides specific evaluation outcomes from the ICH Q4B process for the Dissolution Test Chapter harmonization proposal originating from the three-party PDG. The guidance is in the form of an annex to the core ICH Q4B guidance made available in the
FDA is issuing Q4B Annex 7(R2) as Level 2 guidance under FDA's good guidance practices regulation (21 CFR 10.115). Consistent with FDA's good guidance practices regulation, the Agency will accept comments on the guidance at any time. 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.
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