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The MFDS announces it will shorten the lot release period

By Lee, Tak-Sun | translator Choi HeeYoung

20.12.27 16:16:55

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Upon submission of non-clinical, clinical, and quality data, final approval after consultation

Domestic antibody therapy, scheduled to apply for approval during this month

The MFDS announced on the 27th that a preliminary review is currently underway for three items of COVID-19 vaccines developed by overseas pharmaceutical companies, and that a domestic antibody treatment development company is planning to apply for use approval within this month. The MFDS said that it would approve the COVID-19 vaccine with a target within 40 days after application for approval and within 20 days of national lot release.

According to The MFDS, the drug approval process begins when a manufacturer or importer applies for product approval, and the company submits the data stipulated in Articles 31 and 42 of the Pharmaceutical Affairs Act to the MFDS' Integrated Drug Information System.

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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