Note：○：submission required;　╳： not required;　△：on a case-by-case basis;

*1：Pursuant to relevant regulations promulgated by central health competent health authority

*2：According to Article 24 Paragraph 2, except for those cases being requested to have testing on drug products by central competent health authority, the assessment of quality can be performed through dossier review instead of physical sample testing.
*3: Technical documents of active pharmaceutical ingredients can be substituted by other dossier as promulgated by the central competent health authority.
＋：For generics under post-market surveillance, if the product is still within the surveillance period, local clinical trial reports (including bridging study) meeting the standards that its reference was provided in the original license-granted the NDA should be submitted. If local clinical trial reports (including bridging study) were not in the dossier for the approval of this new drug, one of the following documents should be submitted, (1) BE study report, or (2) BA study and clinical trials reports. For out of surveillance products, either (1) BE study reports, or (2) BA study and clinical trial reports should be submitted.
＋＋：For generic drugs in the controlled release dosage form or promulgated by the central competent health authority to perform BE study, either (1) BE study reports or (2) BA study and clinical trial reports should be submitted. 

1. For a registration application of the controlled drugs manufactured in Taiwan, either the API approval of the controlled drugs or the approval of its legal use should be included.
2. Stability study documentation includes one copy each of the written operation procedures, testing report, quantitative analytical methods and their validation reports.
3. For sterile preparation, the validation report of critical manufacturing processes should include sterilization validation.
4. For toll manufacturing or contract testing products, the contracts should be included.
5. Medical gas refers to CO2, O2 or N2O that are for medical uses with the purity above 99.0%v/v. For CO2 and O2 generated from the air, the stability study reports can be exempt from submission; whilst the documents should be retained for future inspection.