All drug registration projects start with a gap analysis of 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