MFDS Initiates Cancellation of Approval for 6 Drug Items Manufactured by HanAll Biopharma

HanAll Biopharma CI (Photo by HanAll Biopharma)

[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety has decided to temporarily suspend the manufacturing and sales of six drugs manufactured on consignment by Hanall Biopharma and has initiated procedures to cancel their product approvals.

The products subject to approval cancellation by the Ministry are those containing itraconazole, a drug used to treat fungal infections, and are manufactured on consignment by Hanall Biopharma. These include ▲Samsung Itraconazole Tablets (Samsung Pharm) ▲Spodizol Tablets 100 mg (Dasan Pharm) ▲Seetra Tablets 100 mg (Seers Pharm) ▲Enticonazole Tablets 100 mg (Korea Syntex Pharm) ▲Itnazol Tablets (Seohung) ▲Hutra Tablets (Hubist Pharm).

This action follows the confirmation that Hanall Biopharma manipulated stability test data submitted during the approval or change approval process for these products. Stability tests are quality-related tests conducted to establish storage methods and usage periods for pharmaceuticals, and manipulating such data constitutes a violation under the Pharmaceutical Affairs Act as 'obtaining product approval or change approval through false or other unfair means.'

The Ministry also confirmed additional violations of Good Manufacturing Practice (GMP) standards by Hanall Biopharma and plans to proceed with administrative measures such as suspension of manufacturing operations.

Alongside this, the Ministry has distributed safety alerts to medical professionals and pharmacists, requesting cooperation to switch the six products subject to cancellation to alternative medicines and to ensure proper product recalls. The Ministry of Health and Welfare and the Health Insurance Review and Assessment Service have been asked to prevent prescriptions of these products at hospitals and clinics.

The Ministry plans to continue operating a special GMP inspection team to conduct unannounced inspections of pharmaceutical manufacturing sites throughout the year, prioritizing patient safety and swiftly taking necessary actions. Previously, after confirming illegal acts during the manufacturing processes at Binex and Vibozone Pharm, the Ministry established the inspection team to conduct ongoing unannounced inspections in addition to the regular three-year cycle monitoring, aiming to prevent intentional GMP violations from recurring.