Comparative Study on DMF - Royed Training
| wdt_ID | wdt_created_by | wdt_created_at | wdt_last_edited_by | wdt_last_edited_at | Requirement | US FDA | Europe | Japan | India | WHO |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Regulatory Authority | Food And Drug Administration (FDA) | European Medicine Agency (EMA) | Ministry Of Health Labor And Welfare | Central Drug and Standard Control Organization (CDSCO) | WHO |
| 2 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Use Of DMF in suport of application | IND, NDA,ANDA | MAA | PDMA | Prequalification dossier application | |
| 3 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Mandatory | No | No | No | No | No |
| 4 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Provide Information | Drug Substance Intermediate, Drug Products, Flavours etc. | Active Substance | Active Substance , Drug Substance | API, Drug Products, Flavors, Colorants, Etc. | API |
| 5 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Fees For Assessment | ANDA Case Only | No Fee | No Fee | No Fee | No Fee |
| 6 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Submission In CTD Format | Required | Required | Required | Required In Indian CTD format | Required |
| 7 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Forms For DMF Filing | Not Applicable Except Type Ii DMF, Form FDA 3794 | Not Applicable | Applicable Form No. 42 | Not Applicable | Not Applicable |
| 8 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Language | English | English | English And Japanese | English | English |
| 9 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Electronic Submission | eCTD | eCTD | eCTD | eCTD | eCTD |
| 10 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | DMF Number Assigned By Reviwer | Yes | No | Master File Registration Number | No | No |
| 11 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Approved/Disapprove d by Regulatory Authority | Not Approved Only Accepted In Support Of Applications | Only Accepted | Only Accepted | Only Accepted | Only Accepted |
| 12 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Deficiency Letter | Applicable | Applicable | Applicable | Applicable | Applicable |
| 13 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Changes And Approved | Applicable | Applicable | Applicable | Applicable | Applicable |
| 14 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Appointment Of In-Country Care Taker | Applicable | Applicable | Applicable | Applicable | Applicable |
| 15 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Latter Of Authorization | Applicable | Applicable | Applicable | Applicable | Applicable |
| 16 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Closure Or Withdrawal | Applicable | Applicable | Applicable | Applicable | Applicable |
| 17 | roysr | 18/01/2026 02:09 AM | roysr | 18/01/2026 02:09 AM | Reactivation | Applicable | Applicable | Applicable | Applicable | Applicable |
| Requirement | US FDA | Europe | Japan | India | WHO |