The aim of this guideline is to guide and facilitate the process of registration of drug substances by providing matters related to the scope of drug substances to register, as designated by the Commissioner of Korean Food & Drug Administration (hereinafter referred to as KFDA), how to prepare the data, the scope of the data, the requirements of the data to be submitted, the extent of exemption from submission, the standards for processing the application, etc. pursuant to the provisions of Articles 26 and 34 of Pharmaceutical Affairs Act (hereinafter referred to as the "Act") and also Subsection 1, Paragraph 1 of Article 23, Subsections 6, Paragraph 1 and Paragraph 3 of Article 24, Paragraph 1 of Article 40, and Article 83 of the Enforcement Rule under the Act (hereinafter called the "Enforcement Rule"). 此指南的目的是通过提供与原料药注册范围相关的事项，指导并促进原料药的注册过程。相关的事项由韩国食品药品管理委员会指定，根据药物事务法规中的条款26和34，以及法规中的强制条款23第1段中的1部分、条款24第1段中的6部分和第3段，条款40的第1段以及条款83，包括如何准备资料，资料的范围，递交资料的要求，免于提交的范围，处理申请的标准等
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