Date Issued: January 18, 2024
This guideline outlines the essential criteria for monkeypox virus nucleic acid detection reagents. Applicants must assess the applicability based on the specific characteristics of their product. If the guideline is not applicable, it is imperative to provide rationale and the corresponding scientific basis. Additionally, applicants should enhance and refine the content of the registration application materials to align with the unique features of their product.
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