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Tego rules out discipline’s impact on approval of new product
  • By Constance Williams
  • Approval 2017.09.14 15:53
  • comments 0

Tego Science, a maker of wound-healing cell therapy products, has received an administrative measure from the Ministry of Food and Drug Safety식품의약품안전처 to suspend the “TPX-105” clinical trial, the company said Thursday.

Tego Science테고사이언스 will not be able to conduct the clinical trials for TPX-105-- a self-resisting wrinkle-improving cell treatment under approval process -- for a month, it said.

The company failed to report the changes in the evaluation method after the completion of the TPX-105 clinical trial, it said while explaining the reason for the administrative punishment.

Since the company has completed clinical trials for TPX-105, however, the administrative disposition will not affect the process related to the approval of the product, it said.

"This is just one of the general steps in approving a product,” a company official said. "This issue has already been discussed with the phytosanitary inspection unit, and the TPX-105’s approval process is proceeding smoothly."

connie@docdocdoc.co.kr

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