Time to market for drugs approved in Canada between 2014 and 2018: an observational study.

ABSTRACT:

Objectives

This study examines the length of time between when a patent application is filed in Canada for a new drug and when it is available for patients (time to market) and various components of that time. It also looks at whether various factors explain the time between patent application to New Drug Submission (NDS) and compares Canadian and American times. Drugs approved between 1 January 2014 and 31 December 2018 are examined.

Design

Descriptive study.

Data sources

Websites from Health Canada, Food and Drug Administration, Merck Index, United States Patent and Trademark Office, WHO and previously published articles.

Interventions

None.

Primary and secondary outcomes

The primary outcomes are time to market, time from patent application to NDS (pre

SUBMITTER: Lexchin J 

PROVIDER: S-EPMC8258566 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature