The Ministry of Food and Drug Safety has slapped BMI Korea a three-month ban on selling its drug HiDr, an injection to treat wounds on the skin, for uploading unauthorized content about HiDr on the company’s homepage.
BMI Korea posted a notice similar to a news article on its website, saying the company is conducting a clinical trial on PDRN (polydeoxyribonucleotide) injection to compare it with the original drug.
The content also included a planned clinical trial to compare the equality of the approved drug with a control drug; the company’s application in March 2017 for an approval on the clinical trial; the start of the clinical test within June; and a plan to prove the new drug’s efficacy by comparing the approved drug with a generic one by March 2018, and a comparative clinical trial on HiDr Injection.
However, the content was not included in the health authorities’ approval conditions. According to the ministry’s advertisement guidelines for medicines and provision of information on pharmaceutical products, drugmakers can disclose authorized content only on their websites.
The ministry said BMI Korea violated the Article 68 of the Pharmaceutical Affairs Act and the Clause 2 of the Article 78 of the Regulation on Safety of Drugs. The authorities said they would prohibit the company from selling HiDr Injection from Nov. 16 to next Feb. 15.
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