Suwon High Court suspends GMP cancellation order for Dongko Bio Pharma

The Suwon High Court has decided to suspend the effectiveness of a cancellation order regarding the Good Manufacturing Practice (GMP) certification of Dongko Bio Pharma. This ruling allows the company to continue the production and sale of oral solid dosage forms, such as tablets and capsules, until the sentencing of the main appeal case.

The decision follows a similar move by the Supreme Court on October 6, which suspended a GMP cancellation order for Korea Hutex Pharmaceutical until its own final ruling. Both Dongko Bio Pharma and Korea Hutex Pharmaceutical are represented by the law firm Hwawoo in these legal battles, which challenge the legality of the so-called “GMP one-strike out system.”

Legal Dispute Over Proportionality

The central issue in these cases is whether sanctions that halt the production of an entire dosage form based on violations found in only a few items are excessive relative to the nature and extent of the violation. Kwon Dong-ju, a lawyer at Hwawoo representing both companies, stated that while drug quality and safety must be strictly managed, sanctions must be proportional to the violation.

Kwon argued that the “one-strike out system” creates a contradiction by forcing a total factory shutdown for minimal violations, causing excessive sacrifice for the company. He noted that the court’s decision to grant the suspension indicates a need to re-examine the illegality of such orders in light of recent legislative changes.

National Assembly Amends Pharmaceutical Affairs Act to Diversify Sanctions

On October 1, the National Assembly passed an amendment to the Pharmaceutical Affairs Act. This amendment introduces diversified sanctions, providing grounds for “corrective orders” and “suspension of effectiveness for up to six months” as alternatives to the total cancellation of GMP certification. This change allows for penalties that correspond more accurately to the degree of the violation.

A representative from Dongko Bio Pharma expressed relief, stating that the court’s decision ensures the company can maintain the production of oral solid dosage forms and stabilize its consignment relationships with business partners.