Regulations on Management of Medicament Samples and Gifts Article 9

For applications for samples of an investigational drug made in accordance with the stipulations of Article 2, Subparagraph 2, for which sale has not yet been approved by the country of origin, and which application is made for clinical trial purposes, the following materials shall be submitted:I. A written consent from the Institutional Review Board of the teaching hospital at provisional medical center level or above that is conducting the trial, or a written consent from the Institutional Review Board of a specialized teaching hospital that is conducting the trial for a special drug.II. A human trial protocol that is compliant with the stipulations of Article 50 of the Enforcement Rules of the Medical Care Act.III. The Informed Consent Form.If the drug mentioned in the preceding paragraph is a biological drug, the flow of the samples previously applied for shall be attached. However, this is not applicable to initial applications.