Drug Master File (DMF) Management Process

Start des Workflows/Prozesses.

Create a new entry in the DMF Data Model to track the lifecycle of a new Drug Master File.

Assign a task to the Regulatory Affairs specialist to gather all required technical modules (Module 1-5).

Update the DMF entry status to 'Ready for Submission' once all documents are compiled.

Assign a task to the Submission Lead to upload the dossier to the health authority portal.

Record the actual submission date and receipt number into the DMF Data Model.

Retrieve all existing entries related to amendments or updates for the specific DMF ID.

Calculate the regulatory response deadline based on the submission date + standard review period (e.g., 90 days).

If a deficiency is noted, create a task for the Scientific Lead to analyze the regulatory queries.

Increment the version number in the Data Model when an amendment is processed.

Send an automated email to the Quality Assurance and Manufacturing teams regarding the new submission.

Sum the total number of amendments submitted within the last 12 months for regulatory reporting.

Create a summary report showing the current status, upcoming deadlines, and recent changes for all active DMFs.

Create a recurring annual task to prepare and submit the mandatory Annual Report.

Retrieve data entries of certificates or licenses associated with the DMF to ensure they are valid.

Send an automated email alert to the Regulatory Manager when a review deadline is within 15 days.

Ende des Arbeitsablaufs/Prozesses.