The analysis of specimens obtained through clinical trials is conducted by institutions designated by the Ministry of Food and Drug Safety in accordance with Article 34-2, Paragraph 1 of the Pharmaceutical Affairs Act and Article 35, Paragraph 5 of the Safety Regulations for Pharmaceuticals and Other Medicinal Products.
The Korean Institute of Tuberculosis has been recognized by the Ministry of Food and Drug Safety as a clinical trial specimen analysis institution in 2020, adhering to Good Clinical Laboratory Practice (GCLP) guidelines, and providing high-quality clinical trial analysis results for tuberculosis and non-tuberculous mycobacteria pharmaceuticals.
