The documents stipulated in Article 14 of the Pharmaceutical Machinery Law must be collected and prepared as shown below.

1 . It must have been accurately prepared based on the results obtained in an examine or test conducted to prepare the document.

2 . If an examine or test  in the preceding paragraph reveals that the quality, efficacy, or safety of the drug or medical device you are applying for is inadequate, we will evaluate it and include all results in the relevant document.

3 . The related documents that from the basis of the application documentation must be retained until the date of approval decision under Article 14 of the Act.