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Ministry of Food and Drug Safety (Photo courtesy of MFDS) |
[Alpha Biz= Kim Jisun] According to industry sources on June 1, the Suwon District Court will deliver a first-instance ruling on July 10 regarding Samhwa Biopharm’s lawsuit seeking to reverse the Ministry of Food and Drug Safety’s (MFDS) decision to revoke its GMP (Good Manufacturing Practice) certification.
Samhwa Biopharm faced the revocation of its GMP status after it was found to have manufactured six active pharmaceutical ingredients (APIs) in violation of approved specifications and to have falsified related manufacturing records.
The MFDS introduced a “GMP One-Strike-Out” policy in 2022, under which any single confirmed violation, regardless of frequency, can result in immediate GMP certification cancellation. This move came in response to multiple cases in 2021 in which over ten domestic pharmaceutical companies altered additives without approval and manipulated documents, prompting calls for stricter oversight.
To date, five companies have had their GMP certifications revoked under this policy. Among them, Huons Global (Huons Pharmaceutical) lost its first trial and is currently appealing the decision. Dongkoo Bio & Pharma is awaiting a first-instance ruling. Syntech Pharma did not appeal after losing in the first trial and has restarted the GMP certification process, while Doowon Science Pharma accepted the MFDS’s ruling without legal action.
While the pharmaceutical industry has criticized the one-strike policy as excessively harsh, courts have upheld the MFDS's authority, stating that even a single confirmed instance of repeated misconduct justifies revocation of certification. The MFDS is reviewing whether to revise the system, considering both judicial rulings and industry feedback.
AlphaBIZ Kim Jisun(stockmk2020@alphabiz.co.kr)
