ICH SPECIFICATION GUIDANCE
This article was originally published in The Gold Sheet
Executive Summary
...final drafting will await pharmacopeial harmonization of key analytical methods. FDA has published the Step 2 draft of "Q6A" for comment. In lieu of identical standards, USP is pro-posing a "concordance" approach to bridge compen-dial differences. With the implementation of many harmonized guidances underway, ICH has set its sights on an international dossier. The "FDA Modern-ization Act," passed in November by Congress, provides additional support for the agency’s interna-tional harmonization efforts on applications and inspections. The equivalence assessment process under the recently signed mutual recognition agree-ment with the European Union may help further inspection standardization.
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