The Ministry of Food and Drug Safety is likely to decide in mid-May on when it will visit U.S.-based Kolon TissueGene for inspection over how the main ingredient of Invossa-K was mislabeled for over a decade.

The ministry and Kolon Life Science, the parent company of Kolon TissueGene, are reportedly in talks to finalize the schedule. It is highly likely that the decision will come after May 15, news reports said.

“We’re in discussion with Kolon Life Science for the inspection schedule. Nothing has been confirmed yet,” said an official at the ministry’s biopharmaceutical quality management division.

Kolon Life Science said it would soon disclose the date, saying it was “finalizing the inspection schedule.”

By visiting Kolon TissueGene, the developer of the osteoarthritis injection, the ministry will check if Invossa’s cell ingredient was kidney-derived from the initial stage of development.

The ministry requested Kolon Life Science to submit additional data -- on how the main ingredient of the second fluid was replaced with kidney-derived cells and scientific evidence to prove it; why it had labeled it as cartilage-derived cells, not kidney-derived; the initial development plan for the main ingredient of the second fluid that had been considered as cartilage cells; all of the documents related to the manufacturing, producing and confirming of the main ingredient of the second fluid; and whether the results of toxicity tests were about cartilage-derived or kidney-derived cells.

By combining all the data submitted from Kolon Life Science with testing results and inspection results, the ministry will clarify the facts and take suitable measures.

Some media reports said Kolon Life Science did not go through the filtering of kidney-derived cells. However, the ministry said it was looking into the case, and it did not have any facts to confirm the reports yet.

lhs@docdocdoc.co.kr

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