Will GMP One-strike-out be loosened?...MFDS, 'negative'

By Lee, Hye-Kyung | translator Kang, Shin-Kook

24.06.24 05:34:33

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Korea Syntex Pharmaceutical and Hutecs Korea Pharmaceutical receive administrative actions…"Need to set an official agenda item"

MFDS carries out administrative measures for canceling the GMP compliance decision…public disclosure will be put on hold upon suspension of execution through trials

While pharmaceutical companies advocate for loosening the 'Cancellation of the GMP compliance decision' act, the Ministry of Food and Drug Safety (MFDS) says it will start a discussion once it receives an official submission of opinions.

This is in response to biopharmaceutical companies’ submission of a statement last month regarding the necessity of improving the 'Cancellation of the GMP compliance decision' act. The groups have continuously voiced concerns over the policy.

According to industry sources on June 24th, the MFDS’ GMP One strike-out was applied to Korea Syntex Pharmaceutical earlier this year, following Hutecs Korea Pharmaceutical at the end of last year. After the cour

Lee, Hye-Kyung(hgrace7@dailypharm.com)

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