Guard Your Proprietary Product Data with a Master File Submission
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or National Medical Products Association (NMPA) in China.
Registrar Corp prepares and submits Drug, Medical Device, and Veterinary Master Files to 18 regulatory agencies worldwide.
What is a Master File?
As part of certain drug and medical device applications to regulatory agencies, a company may need to reference data from another product used in the manufacture of their own, such as packaging, ingredients, or accessories. The owner of this data may choose to submit a Master File to disclose proprietary or confidential information concerning their product to a regulatory agency without providing it to parties that need to reference it.
Many agencies require submission of Master Files in electronic common technical document (eCTD) format.
Common types of Master Files
Drug Master Files (DMFs) and Active Substance Master Files (ASMFs)
Submissions of proprietary information on human drugs and substances, including information on:
- Drug substances and products
- Packaging materials
- Excipients and preparation materials
- Facilities and their procedures
- and More
Medical Device Master Files (MAFs)
Submissions of proprietary information on medical devices, including information on:
- Facilities and their procedures
- Device formulations
- Packaging materials
- Clinical and non-clinical study data
- and More
Veterinary Master Files (VMFs)
Submissions of proprietary information on veterinary drugs and substances, including information on:
- Packaging materials
- Excipients and preparation materials
- Facilities and their procedures
- Testing methods
- and More
Registrar Corp Submits Master Files to the Following Agencies
U.S. Food and Drug Administration (FDA)
Health Canada
Chinese National Medical Products Administration (NMPA)
Other locations Registrar Corp can help submit to:
- Australia
- Bahrain
- Bosnia and Herzegovina
- European Union
- Hungary
- Jordan
- Kuwait
- Oman
- Qatar
- Saudi Arabia
- South Africa
- Switzerland
- Thailand
- United Arab Emirates
- United Kingdom
Submit your Master Files in eCTD
What is eCTD?
Electronic common technical document (eCTD) format is a standard submission format for Master Files. Agencies such as FDA and Health Canada require eCTD format for certain types of Master File submissions, including DMFs and ASMFs.
Should I Convert My Existing Master File to eCTD?
eCTD requirements vary per agency. Existing Master Files that are not in eCTD format, including those in paper form, typically do not require resubmission to FDA; however, additional submissions such as annual reports, supplements, and amendments must be submitted to FDA in eCTD. Likewise, Health Canada requires all Master Files to be submitted in an electronic format that may be eCTD.
Regardless of requirements, companies typically convert their existing paper Master Files to eCTD to expedite the review process of an NDA or ANDA that references the Master File.
How Do I File an eCTD Submission?
eCTD submissions are typically required to be sent through an Electronic Submissions Gateway (ESG). Access to an agency’s ESG often involves a lengthy application and computer configuration process. This process may require several weeks of preparation, agency correspondence, and testing.
Alternatively many companies choose to hire a Regulatory Specialist, such as Registrar Corp, to convert their Master File submissions to eCTD format and submit the Master File on their behalf.
Registrar Corp Makes Master Files Easy
Registrar Corp’s Master File Service includes:
Assistance with preparation of Master File submissions and amendments
Submission of your MF to the requested Regulatory Agencies
A secure online portal to access your MF submission documents at any time
