All drug registration projects start with the gap analysis process on the dossier. This downloadable checklist sheet lists all the dossier required files for different types of drug applications.

In this file, you will find the following information:

• List of 300+ files required by the SFDA for drug registration.
• Scope: new drugs (NCE, Biological, Biosimilar), and generic drugs.
• The eCTD file structure, modules (m1, m2, m3, m4, m5)
• Notes clarifying whether the section is mandatory for generic drugs.
• Highlighting the sections that PharmaKnowl will prepare and those that must be supplied by the applicant (MAH).

Checklist last updated in May 2025