Regulations for Approval of Specific Medicinal Products' Manufacturing or Importing as a Special Case Article 4

While the central competence authority reviews the application in accordance with the preceding two articles, shall take the situation, risk and benefit, and amounts calculation methods listed in Paragraph 1 of Article 48-2 of the Act into consideration. When approved, it may be with additional conditions imposed.While the central competence authority make the decision of approval or disapproval may consult with scholars or professionals or convenes an expert review meeting when necessary, and may publicize the scholars and expert opinions or conference related information or medical products’ approval assessment report, but the authority shall keep in confidence any trade secrets.