The Ministry of Food and Drug Safety said it has given an administrative warning against AnC Bio and N&N Pharmaceuticals Asia for not submitting clinical trial status reports.
AnC Bio failed to submit the status report on the phase-2, open-label, randomized, and multicenter study to assess cardiovascular effects and safety of “MyoCell,” implanted by a catheter delivery system in post-myocardial infarction patients with congestive heart failure.
N&N Pharmaceutical Asia also did not submit the status report on the phase-1 study on N-Methanocarbathymidine (NN-001)’s safety and pharmacokinetic effects in healthy adults, the ministry said.
According to the regulations under the Pharmaceutical Affairs Act, those who have received approval for a clinical trial plan should submit the status report of the study and the safety information summary report to the minister of food and drug safety by the end of March next year.
“If the companies disagree with the administrative warning, they may file an administrative appeal with the food and drug safety ministry or the administrative appeal committee within 90 days from the date of the warning, or file an administrative suit under the Administrative Litigation Act,” the ministry said.