[Reporter’s View] An open talk on improving the GMP system

is necessary

Last month, CEOs of biopharmaceutical companies submitted a statement to the Ministry of Food and Drug Safety (MFDS) requesting an improvement to the 'Cancellation of the GMP compliance decision (GMP One strike-out).' They asked that if non-compliance with GMP has been unintentional, a different set of measures be applied instead of one strike-out.

 

On December 11, 2022, the MFDS initiated a GMP One strike-out act.

 

According to this act, when a company is found to be in violation of the Good Manufacturing Practices (GMP) for medicinal products, their GMP compliance approval may be revoked.

 

This measure has been established due to past incidents in which more than ten companies, including Binex, Vivozon Pharmaceutical, Hanall Biopharma, Dongindang Pharmaceutical, Hansol Pharm, Samsung Pharm, and Medica Korea, altered ingredients without authorization, falsified documents, and provided false information on approval documents.

 

The GMP One strike-out act states that if a company violates GMP compliance, such as obtaining GMP compliance decisions based on false information or illegally and repeatedly falsifying GMP records, action will be taken.

 

This year, there was a case of canceling the GMP compliance decision, and some items will soon be withdrawn.

 

When a company receives a GMP One strike-out, manufacturing the offended item and the same formulation will be stopped.

 

The system was implemented one year and six months ago.

 

During this period, Hutecs Korea Pharmaceutical received a disposition and is pursuing a trial.

 

The companies expecting a disposition may not readily accept the MFDS’s disposition.

 

Consequently, there should be an opportunity to hear the opinions of biopharmaceutical companies CEOs regarding their statement for revising the GMP One-strike out system.

 

The MFDS has reviewed the CEO’s statement regarding the GMP One-strike out system.

 

However, the MFDS has not publicly discussed this matter or announced its official opinion.

 

The MFDS may open a session with the CEOs if the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), which represents biopharmaceutical companies in South Korea, officially submits a statement.

 

However, the MFDS prefers to discuss this matter unofficially.

 

The GMP One-strike out system has been implemented as part of revising the Pharmaceutical Affairs Act Article 38-2 (Standards of Manufacture and quality control).

 

Since this system was established by the National Assembly, the MFDS, an administrative agency, feels certain pressure to discuss measures for revision.

 

However, this policy has been implemented over one year and six months ago.

 

There is a need to conduct a public review of the system.

 

If the KPBMA proposes a clear agenda regarding this system, the MFDS official should provide an opportunity for official discussion.