Export Flu Vaccine National Shipment Approval Issuance Time Reduced by Up to 10 Days

The Ministry of Food and Drug Safety announced on the 28th that starting next month, it will expedite the national batch release approval process for export vaccines to support the export of domestically produced influenza vaccines (Flu vaccines).

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National batch release approval is a system that comprehensively evaluates and verifies the manufacturing and testing results of biological products such as vaccines according to each manufacturing lot, ensuring they are produced as authorized by the manufacturer.

While this system has the advantage of rigorously verifying vaccine quality, there have been repeated concerns that the lengthy procedure makes it difficult to meet supply schedules for flu vaccines, which must be manufactured using strains predicted annually by the World Health Organization (WHO).

In response, the Ministry of Food and Drug Safety announced that if companies request cooperation for national batch release approval based on an accurate delivery deadline, the processing period will be shortened by 5 days. The existing processing time of 20 days will be reduced to 15 days.

The Ministry will maintain the current system where the application is submitted first and the summary document is submitted within 5 days after the application.

A Ministry official stated, “Companies can submit the national batch release approval application at least 5 days before submitting the summary document, and with the 5-day reduction in processing time, the issuance of the national batch release approval certificate is expected to be advanced by up to 10 days.”

This content was produced with the assistance of AI translation services.