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The guidance provided in this Annex is applicable to the manufacture and control of bulk intermediates and finished Schedule D (biological) drugs including vaccines; fractionated plasma products (human, animal); antigens; allergens; hormones; cytokines; enzymes and products of prokaryotic and eukaryotic cell cultures (including monoclonal antibodies and products derived from rDNA technology). Interpretation of GMP requirements for the collection and processing of human blood and blood components is not within the scope of this guidance.

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This document provides guidance to industry for the preparation of submissions according to the format presented in the ICH CTD.
Each country has its own application licensing procedure and specific forms to comply with its National legislation. This section describes how the ICH CTD format applies to the specific requirements for vaccines. Vaccines are always considered new products for licensing purposes.

  • Module 1 Administrative Information and Prescribing Information
  • Module 2 Common Technical Document Summaries
  • Module 3 Quality
  • Module 4. Nonclinical Study Reports
  • Module 5. Clinical Study Reports
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