As the Ministry of Food and Drug Safety announced the results of an administrative investigation of Binex and non-conservative pharmaceuticals,’the obligation to manage and supervise consignees’ emerged as another issue, and the aftermath of this voluntary change in the pharmaceutical manufacturing process is expected to expand to the entire domestic pharmaceutical industry. .
On the 25th, the Ministry of Food and Drug Safety announced the results of an administrative investigation conducted on Binex and non-preservative pharmaceuticals. He said that violations of the Pharmaceutical Affairs Act were found in common.
The Ministry of Food and Drug Safety has collected and inspected products with confirmed violations, and as a result, there is no problem with safety, but the current administrative investigation has been converted to investigation in order to prevent the concealment and disposal of related documents by pharmaceutical companies that have been investigated.
Furthermore, the Ministry of Food and Drug Safety confirmed the violations of negligence in management and supervision of some pharmaceutical companies as a result of checking 24 Binex consignment companies and 5 non-preservative pharmaceutical consignment companies entrusting the manufacturing of generic drugs with violations found. Disposal measures were announced.
The Ministry of Food and Drug Safety also announced the results of emergency special inspections of 30 consignment and consignment factories nationwide.
As a result of an emergency special inspection, no cases of violations identical to those of Binex and non-preservative pharmaceuticals were confirmed, but administrative measures were taken after confirming violations of drug manufacturing and quality control standards, such as not conducting a test for finished products and raw materials at one site, and not preparing some product standards. I am going to do it.
The Ministry of Food and Drug Safety announced that it would establish a’Pharmaceutical GMP Special Planning and Inspection Group’ to prevent the recurrence of this situation, and conduct irregular inspections on a regular basis. It also plans to strengthen penalties such as cancellation of GMP conformity determination and imposition of punitive penalties, and to increase the administrative disposition for non-compliance with the trustees’ compliance matters, such as the management and supervision of the trustee.
However, it will take a considerable amount of time for the two pharmaceutical companies to take administrative measures.
An official from the Ministry of Food and Drug Safety said, “The results announced this time are based on administrative investigations, and the investigation is still underway. In the event of a new violation in the investigation process, the administrative disposition will be finalized, including the relevant details.”
Meanwhile, as the Ministry of Food and Drug Safety announces the results of the administrative investigation, the Pharmaceutical Bio Association is also in a position to reflect the results in the association’s response. In connection with this situation, the Pharmaceutical Bio Association once held an ethics committee on the 18th.
An official from the Pharmaceutical Bio Association said, “As the results of the KFDA’s administrative investigation have come out, we will reopen the Ethics Committee sooner or later, and comprehensively judge the results of this investigation in addition to the existing hearing procedures and fact-related confirmation procedures.”
The timing of the second ethics committee has not been decided yet.
The official said, “The level of disposition will be comprehensively judged by the committee and lowered.”