Qurious RI DMF Database Module for Global DMF and CEP Tracking

Table of Contents

Qurious RI’s DMF Database module offers a platform for tracking evidence-based, audit ready DMFs and CEPs status for APIs and excipients across multiple jurisdictions. The platform proposes a centralized tracking across multiple databases such as EDQM, USFDA, NMPA, and others which reduces the time and effort of manual cross checking against each database individually. Thus, this enables faster time to market through new registrations and variations.

Key Benefits of the Qurious RI DMF Database Module

Single Platform: Multiple Jurisdictions– Checks DMF/CEP status for API and excipients across multiple countries such as US, EU, China, Brazil, etc. on a single platform.

Consistent/Auditable– Standard check for each source and retrieval date recorded.

Change in Status Notifications– Centralized check for status of DMF for all ingredients/portfolio with automated alerts.

Reduced Time to Market and Ongoing Compliance– Re-use verified DMF/CEP status for multiple products across multiple markets. This eventually reduces time for new registrations and variations.

Key Features of the Qurious RI DMF Database Module

Muti-Agency DMF/CEP Status Tracker	Track status of your DMF/CEP through multiple countries agencies such as USFDA, EU DMF, China DMF, Brazil DMF, etc. through EMA/EQDM. Source and retrieval data recorded for every status check.
DMF/CEP Status Database	Global repository for API/excipients, markets/agencies, etc. Side comparison view for DMF/CEP status across multiple countries for each substance/portfolio.
DMP/CEP Verification Workflow	Guided DMF/CEP status per target market for each API and excipient in your portfolio. Gaps detected and flagged such as no filing found, inactive/active/withdrawn status.
Portfolio Dashboard	Dashboard filters by market, dosage form, substance type, etc. Substance and portfolio status by market.
DMF/CEP Status Change Tracker	Continuous tracking of DMF status. Automated alerts when status affects tracked products.

Conclusion

Managing DMF and CEP status across multiple markets can become difficult when information is spread across different regulatory databases. Qurious RI brings these checks into one platform, helping regulatory teams track API and excipient status, identify changes, maintain an auditable record of source checks, and monitor potential gaps across a portfolio.

By tracking status changes and alerting teams when a DMF or CEP may affect a product or submission, the module can reduce repeated manual database checks and support better regulatory planning for new registrations, variations, and ongoing compliance.

Explore Qurious RI to learn more about the platform and its regulatory intelligence modules.

FAQs

What is a DMF and why does its status matter?

A Drug Master File (DMF) is filed by an API manufacturer with the health authority. Usually, the DMF contains two parts that is the open part which contains API properties, specifications, etc. and the other part is the closed/confidential data i.e. formulation details. This confidential data is given an DMF number, which the drug companies mention in their own filings. If this referenced DMF goes inactive/withdrawn or is amended without your dossier being updated, it can affect your approval process. That is why a DMF status matters a lot and is thus necessary to track the DMF status for your portfolio.

How does the DMF database module actually work and help reduce manual work?

Qurious RI’s DMF database module provides a one stop platform for tracking the DMF status across multiple county databases. It flags any status changes, i.e. active, inactive, suspended or amended and gives you an automated alert to keep you timely updated and compliant.

Does an inactive DMF mean we can’t use that API?

Not necessarily. It does not affect the already approved products. The main focus of inactive DMFs is new registrations, new variations, or INDs/NDAs still under review using the inactive DMF number. The DMF database on Qurious RI flags such cases, so in early phase you can amend the required changes, and this saves you from later reverting of your applications.