A Drug Master File (DMF) is a voluntary registration that provides confidential information such as specific processes or components used to manufacture, process, or package a drug. DMF Health Canada submissions are a useful vehicle for providing confidential business information (CBI) to Canada’s regulatory body. They are designed to shield sensitive information from disclosure to the manufacturer of the dosage form, sponsors of a drug submission, applicants of a DIN (drug identification number) application, or clinical trial application (CTA).   

Master Files are references filed with Health Canada. They can be referenced by applicants seeking drug marketing authorizations or clinical trial authorizations involving pharmaceuticals and biologics.

Five different types of Master Files

There are five different types of Master Files:

• Type I: Active Substance Master Files (ASMFs) 
• Type II: Container Closure System Master Files (CCS MFs) 
• Type III: Excipient Master Files  
• Type IV: Dosage Form Master Files (dosage form MFs) 
• Type V: Facilities and Equipment Master Files (FMFs) 

Like the U.S. Food and Drug Administration (FDA), Health Canada requires new MFs to be submitted in electronic Common Technical Document (eCTD) format. Health Canada Master File submissions are also submitted through FDA’s Electronic Submissions Gateway. 

Health Canada Requirements for Master Files 

Even though Health Canada and FDA share a submission Portal, Health Canada has unique requirements for MF submissions such as (but not limited to):   

• Sample Master Files: Any sponsor (holder or agent) filing Master File regulatory transactions in the eCTD format for the first time must file a sample for each MF Type (I to IV) prior to the formal regulatory transaction, regardless of the sponsor’s experience with filing in eCTD format. This process may take months to complete. 

• Letter of access: At least one letter of access allowing an applicant to reference the MF must be included with every new submission. Master Files cannot be submitted to Health Canada unless they will be referenced in an application. 

• User fees: Health Canada charges user fee payments for new submissions, quality updates, and letters of access submissions. These fees increase annually by 2% on the first of April each year. 

• Master File structure: Health Canada has different requirements regarding the structure of the MF depending on type, such as the inclusion of Applicant and Restricted Parts (AP/RP). 

• Administrative documentation: Additional administrative documents depending on the type of Master File, which may include a certificate of suitability information for ASMFs.   

DMF Submission to Health Canada is Challenging 

Submitting Health Canada DMFs can be a complex business, requiring time, resources, and significant documentation. However, using DMF Specialists like those at Registrar Corp assures that your DMF will be filed properly and promptly while also keeping your intellectual property confidential. Learn more about our Drug Master Files services and how we can help you with your submissions today.