Defendant shall be punished by a fine of KRW 2,000,000.

When the defendant does not pay the above fine, 100,000 won.

Punishment of the crime

The Defendant is a person working as the director of the research institute in B Co., Ltd. (hereinafter referred to as “B”), a company manufacturing and selling pharmaceutical products, from July 2014 to March 2017. D is a person who has been working as the representative director in B from around 1998, and E is a person who has been working as the director of the research institute in B’s new medicine from around 2004 to July 2018, and F is a person who has worked as the managing director of the research institute in G affiliated with the blood testing company from around 2013 to March 2018.

Any person who intends to conduct clinical trials due to drugs, etc. shall prepare a plan therefor and obtain approval from the Minister for Food and Drug Safety.

However, since clinical trials are administered with drugs that have not been fully verified safety against people, there are always concerns over causing unexpected side effects and causing harm to the health and life of a person subject to testing. Accordingly, in cases where clinical trials are regularly conducted in accordance with the above approval contents, ① recruitment of applicants through public announcement in accordance with strict standards, ② determination of whether a person in charge of testing prior to conducting a clinical test falls under the criteria for exclusion from the selection of a person subject to testing should be made (in particular, in most cases, women fall under the criteria for exclusion from the selection of a person subject to testing), ③ detailed side effects on the selected persons, ③ detailed side effects on the selected persons, and ④ monitoring of the designated medical institution’s procedures such as conducting a test and post-examination of health conditions.

B. In the event that a regular clinical trial is conducted as approved, it requires a considerable amount of cost and a considerable period of time up to KRW 00 billion, and where a clinical trial is conducted with approval and the result fails to meet the standards, it is necessary to start the development and test process from the beginning, which is approved.