The current Act prescribes matters that a person who intends to conduct a clinical test and a clinical testing institution, when conducting a clinical test, shall comply with, and prescribes that such person and testing institution shall be subject to sanctions in case of violation.

There are no regulations, however, regarding matters that a person actually conducting a clinical test shall comply with, nor sanction measures in case of violation, such that there has been criticism that there are limits to ensuring the safety and ethicality of clinical tests.

Therefore, this proposal aims to prescribe matters regarding protection, etc., of clinical test subjects and matters that a clinical test manager shall comply with when he/she intends to conduct a clinical test, and enable a clinical test manager to be changed or removed from a clinical test for a certain period in case of violation (Article 10 (5), 37-2, newly inserted).

Prescribe matters that a clinical test manager shall comply with when he/she intends to conduct a clinical test, and enable a clinical test manager to be changed or removed from a clinical test for a certain period in case of violation (Article 10 (5), 37-2, newly inserted)