Data Requirements for Human Drug Submission updated version 2.1 for GCC CTD

New Guideline Data Requirements for Human Drug Submission updated on 24-October-2017 Version 2.1 for GCC CTD. The Saudi Food and Drug Authority (SFDA) has updated its Gulf Cooperation Council (GCC) data requirements for human drugs submission. The data requirements for each application will differ, depending on the drug submission type and all the required data should be in accordance with the CTD structure.

https://www.sfda.gov.sa/en/drug/drug_reg/Pages/default.aspx