How long do new medicines take to reach Canadian patients after companies file a submission: A cohort study.

ABSTRACT:

Introduction

Studies of the delay between when companies file a New Drug Submission (NDS) and when drugs reach Canadian patients typically focus on the time in the regulatory review process and do not analyze the time between when approval is granted and the drug is available for purchase (company decision time). This study looks at the length of the two different time periods. Secondarily, it examines whether there is a difference in these time periods for drugs that received a standard review and those that received an expedited review.

Methods

A list of all New Active Substances approved in Canada between January 1, 2014 and December 31, 2018 was compiled and the dates when the companies applied for a NDS, the dates when the drugs received a market authorization (Notice o

SUBMITTER: Lexchin J 

PROVIDER: S-EPMC7605702 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature