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Executive Summary

ICH STABILITY GUIDELINE WILL NOT BE EXTENDED TO GENERIC DRUGS, the International Conference on Harmonization quality working group concluded during its March 8-10 meeting in Brussels. The elimination of generic drugs from consideration in the European Community/Japan/U.S. "tripartite guideline for the stability testing of new drug substance and products" presumably means generic drugs will be excluded from other harmonization documents, such as one covering impurities, as well. FDA is currently preparing four harmonization documents for publication: stability, reproductive toxicity, geriatrics and dose response. Notice of availability is expected by mid-April. At the recent annual meeting of the National Association of Pharmaceutical Manufacturers, FDA Office of Generic Drugs Associate Director for Chemistry Robert Jerussi reported that the first draft of an extension document that would have covered generic drug stability was issued in October. Jerussi warned that inclusion of generics in the stability standards alone could delay ANDA submissions by up to nine months ("The Pink Sheet" Feb. 15, T&G-3). Another issue of concern discussed at the NAPM meeting focused on the possible impact of new EC patent laws on the importation of active ingredients to the U.S. for pre-patent expiry testing. Sen. Pryor (D-Ark.) has asked the U.S. Trade Representative to examine the issue (see preceding T&G). While the decision not to extend the stability document to generic drugs means that there will be no immediate impact on generics, FDA noted that if the U.S. does harmonize its drug standards there will eventually be some effect on industry. As part of the overall harmonization process, FDA plans to hold a public meeting to address stability and impurities issues, the agency said.

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