Drug Master Files (DMF)
Drug Master File registration
For drug registrations in the USA, Canada, and China, SCHOTT Pharma prepares descriptions of pharmaceutical packaging products and registers them in Drug Master Files (DMF). These files separate the descriptions of the pharmaceutical packaging or medical device from the descriptions of the final drug or medical device.
The content that SCHOTT Pharma contributes to the DMF is referenced via a Letter of Authorization (LoA). During authority review, the LoA is considered part of your drug application. You can use the DMF and LoA references provided by SCHOTT Pharma for the same pharmaceutical packaging across multiple drug applications.
Drug Master Files from SCHOTT Pharma for fast and seamless referencing
Our Regulatory Affairs and Compliance Team takes care of generating, filing, and updating DMFs. In the USA and Canada, DMF filings are generated and maintained in eCTD format, while in China we create and maintain bilingual DMFs in a China-specific dossier format.
Our DMF setup enables customers to use SCHOTT Pharma containment and delivery solutions as pharmaceutical packaging or medical devices. In format and content, our DMFs follow the latest authority guidelines to promote a fast and seamless review of your drug application.
SCHOTT Pharma’s DMF’s: a single, complete dossier
Drug Master Files: How to proceed
In the USA and Canada, DMFs are available for our platform products to ensure smooth regulatory approval. Additional registrations may be required for customized products or registrations in China.
If urgent authority responses are required, please use the contact form or inform your sales contact to establish direct support via our regulatory experts.