Pharmaceutical Bio Association: "Bionex Incident, Unacceptable Illegal Act... Will Punish Severely"

Published 11 Mar.2021 10:35(KST)

"Separate Measures Including Referral to Ethics Committee... An Opportunity to Thoroughly Inspect Overall Quality Management Status"

[Asia Economy Reporter Kim Ji-hee] The Korea Pharmaceutical and Bio-Pharma Manufacturers Association has announced its stance to take strict disciplinary actions, including referring Bionex to the Ethics Committee. It also plans to lead efforts to prevent recurrence by thoroughly inspecting the contract manufacturing processes and overall quality management status of member companies' pharmaceuticals.

Earlier, the Ministry of Food and Drug Safety recently confirmed arbitrary changes by Bionex to the main ingredient dosages and manufacturing methods of pharmaceuticals, and took measures to suspend manufacturing and sales and recall 32 items produced under contract from 24 companies.

On the 11th, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association stated in a press release, "Although the facts will be fully revealed through additional on-site investigations by the Ministry of Food and Drug Safety, the Bionex incident is an unacceptable illegal act, which is deeply shocking."

The association said, "We deeply regret this incident and take it very seriously," adding, "Regardless of the Ministry of Food and Drug Safety's additional investigations and government authorities' measures, we will promptly and thoroughly ascertain the truth and take firm disciplinary actions, including referring Bionex to the Ethics Committee." It continued, "Taking this incident as an opportunity, we will swiftly take measures to inspect the contract manufacturing processes and overall quality management status of member companies' pharmaceuticals to meet the trust and expectations of the public."

It also promised efforts to prevent recurrence. The association stated, "We will do our best to rationally improve pharmaceutical quality management and the contract bioequivalence and joint development system, including actively cooperating with the National Assembly legislation for the prompt institutionalization of the '1+3 restriction' on contract and joint bioequivalence studies to prevent the uncontrolled proliferation of generic drug contract manufacturing."

Finally, the association emphasized, "We hope that the exceptional deviation and illegal acts of a specific company will not deteriorate into a trust issue for the entire industry. It is regrettable that such an incident occurred at a time when public interest and expectations for the domestic pharmaceutical and bio industry have risen unprecedentedly due to the COVID-19 pandemic, and we will take this situation as an opportunity for self-reflection."