Guidance on procedures and administrative requirements for master files: Overview

Document change log:

Date adopted: 2008/08/08
Effective date: 2023/06/26

Organization: Health Canada

Date published: June 2023

Cat.: H164-267/2023E-PDF

ISBN: 978-0-660-49152-3

Pub.: 230136

On this page

• Introduction
• Policy objective
• Policy statements
• Scope and application
• Background
• Note about guidance documents in general

Introduction

A master file (MF) is a reference that provides information about specific processes or components used to manufacture, process or package a drug. The MF is a useful vehicle for providing information to Health Canada, where that information is confidential business information (CBI) and is not available to the:

• manufacturer of the dosage form or
• sponsors of a drug submission or
• applicants of a DIN (drug identification number) application or clinical trial application (CTA)

Health Canada must protect confidential business information in accordance with the law.

This guidance document provides MF-related definitions, information on filing requirements, processing and assessment procedures for Type I to V MFs. It also outlines the registration requirements for new MFs, as well as other MF transactions including administrative changes, updates, withdrawals and closures.

Policy objective

The policy objective is to provide direction on the procedures that allow MF holders, authorized MF agents and authorized third parties filing on behalf of MF holders to file CBI directly with Health Canada. The CBI referenced is in support of an applicant’s drug submission (including DIN applications) or CTA with respect to quality information.

Note: ‘MF holder’ includes authorized MF agent and authorized third parties filing on behalf of the MF holder. This term is used throughout this guidance document.

Policy statements

MFs are categorized as regulatory transactions.

For more information, consult:

• Guidance document: Preparation of regulatory activities in non-eCTD format
• Guidance document: Preparation of regulatory activities in the electronic common technical document (eCTD) format

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

Applicants are responsible for submitting non-confidential business information provided by the MF holder. This information is public and/or developed by the applicant in the drug submission, DIN application or CTA.

The information included in the MF should be up-to-date. Applicants should also contact the MF holder to confirm that Health Canada has received this information before filing their submission, DIN application or CTA with us.

The restricted part of the MF will be held in strict confidence. Health Canada will used it in support of the drug submission or CTA only when we have received a written letter of access (LoA) from the MF holder.

The LoA is signed by the MF holder. It indicates to Health Canada that the applicant and MF holder have agreed that the MF can be referred to during Health Canada’s assessment of the drug submission or CTA.

Scope and application

This guidance document applies to all MF holders or applicants that use an MF to support drug submissions and DIN applications for human use or CTAs. It also applies to Health Canada employees involved in MF processes.

Submissions and applications include the following:

• extraordinary use new drug submission (EUNDS)
• new drug submission (NDS)
• new drug submission with flexibilities for designated COVID-19 drug (NDS-CV)
• abbreviated new drug submission (ANDS)
• abbreviated EUNDS (AEUNDS)
• supplements
• applications for DINs (DINA and DINB)
• post-DIN changes for pharmaceuticals (PDC)
• notifiable changes (NC) (in the case of biologics)
• post-authorization Division 1 changes for biologics (PDC-B)
• yearly biologic product reports (YBPR)
• CTAs, CTA-notifications (CTA-N) and CTA-amendments (CTA-A)

MFs may be referenced by more than 1 applicant.

The guidance document also applies to MF holders intending to file MFs that are cross-referenced in drug submissions and DIN applications for products for both human and veterinary use or CTAs.

For information on the requirements for MFs related to veterinary drug products and substances, consult:

• Guidance document: Master files for veterinary products: Procedures and administrative requirements

The guidance document does not apply to MFs used in support of natural health products (NHPs) subject to the Natural Health Products Regulations. For NHP MFs, contact the Natural and Non-prescription Health Products Directorate (NNHPD) at nnhpd.consultation-dpsnso@hc-sc.gc.ca.

MFs are classified according to the types listed in Table 1.

Background

The principles outlined in this guidance document are intended to create greater alignment with the procedures used internationally for the management of MFs. Extensive knowledge has been gained through international regulatory initiatives such as the International Generic Drug Regulators Programme (IGDRP).

This guidance document also incorporates procedures and terminology from the International Council for Harmonisation (ICH) guidelines and the use of certificates of suitability to the monographs of the European Pharmacopeia (CEPs).

In keeping with international best practices, the term ‘master file’ (MF) is used. This term was previously known as drug master file (DMF).

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the accompanying notice and the relevant sections of other applicable guidance documents.