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MFDS drug review result to be disclosed within 2 months

By Lee, Tak-Sun | translator Byun Kyung A

21.03.12 06:18:14

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Shortened from 4 months, confidentiality requested items would also disclose summary

To improve the people¡¯s right to know and transparency, procedure to be streamlined


The pharmaceutical review result for new drug would be disclosed within two months from the completed date. Compared to four months taken at the moment, the information disclosure deadline would be cut by two months. Regardless of the affected company¡¯s request for non-disclosure, the summarized information would be publicly opened to improve the people¡¯s right to know.

South Korea¡¯s Ministry of Food and Drug Safety (MFDS) has convened an online seminar on pharmaceutical approval on Mar. 11 and explained the revised regulation. In last December, the ministry drew a guideline up and informed in advance of the information disclosure.

Deputy Director Kim Byoung-sam at MFDS Approval Man

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