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

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 court suspended execution due to administrative claims, opinions were gathered to rediscuss the policy.

 

“We are open to meeting regarding the issue,” Kim Sang Bong, Director of the Pharmaceutical Safety Bureau, said.

 

“To our knowledge, there is an official committee within the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), and we would like them to submit an official statement of opinions.” According to a statement from biopharmaceutical companies, if non-compliance with GMP has been unintentional, a different set of measures should be applied instead of one strike-out.

 

"The National Assembly legislation has enacted a policy for the cancellation of the GMP compliance decision,” Kim said.

 

“As this policy is not part of the MFDS’ administrative rules, MFDS is simply carrying out the legislative body’s policy.” As a result, even if companies request that the policy be loosened within the law, MFDS has nothing to offer because it is a regulatory agency.

 

“We acknowledge that the pharmaceutical industry regards the one-strike-out policy as a significant issue, we are open to meeting when they request discussion through the Quality Committee,” Kim said.

 

“When there is an agenda, we will visit the KPBMA for a discussion.” On December 11, 2022, the MFDS initiated a GMP one-strike-out act.

 

According to this act, when a company is found to violate the Good Manufacturing Practices (GMP) for medicinal products, such as falsely receiving GMP approvals or falsely documenting GMP repeatedly, their GMP compliance approval may be revoked.

 

Hutecs Korea Pharmaceutical was the first target of this act and received a disposition, and their plant was suspended and then re-opened after the suspension of execution.

 

Korea Syntex Pharmaceutical was in the process of canceling the GMP compliance decision, but it has been put on hold.

 

Dongkoo Bio&pharma is expected to be the third target for canceling the GMP compliance decision.

 

An official from the MFDS said, “In general, the details of disposition are posted through the website, and we cannot provide answers to a matter under review.” “We have released the first case details of Hutecs Korea Pharmaceutical through a press release to inform the industry of GMP adherence.

 

We reviewed the scope of the disposition and criteria,” an official added.

 

The MFDS states that apart from Hutecs Korea Pharmaceutical, other companies that receive the cancellation will not be disclosed when there is a suspension of the act through trials.

 

Once the cancellation is confirmed, it will be posted on the website.