ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - annexes

The examples provided in Annex IA through IF are mock examples provided for illustrative purposes. They only suggest how the tools described in chapters 3, 4, and 5 could be applied, and should not be used as a template or the sole basis for a regulatory submission. In addition, the reporting categories, as described in Chapter 2, may differ across regions depending on regional legislation, the nature of the product, and the MAH’s demonstrated understanding of the product, process, and analytical procedure.

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