Improving access to generic drugs

This project will:

• increase review capacity for generic drugs
• propose amendments to the Food and Drug Regulations to assist the access to generic drugs
• involve worksharing and information-sharing with other international regulatory partners

The increased review capacity and international work will result in earlier access to:

• more affordable drugs
• new treatment options
• a more secure supply of drugs

The updated regulations will help drug makers understand what information should be included in their drug submissions. This will help with product approval and availability.

Consultations on the Notice of Intent (NOI) "Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology" have already taken place. They closed in October 2017.

The tasks for this project include:

• ongoing hiring of review staff
• publishing draft regulations
• publishing final regulations

We expect that all parts of the project will be fully in place by fall 2020.