Submission Rates and Review Times

The collection of data on the submission and review of regulatory dossiers for new active substances in different regions of the world has been a major activity of CMR International for many years. With the establishment of the Institute in 2002, data collection projects that involve data from regulatory sources and interaction with the regulatory agencies have been continued.

REGULATORY REVIEW TIMES

Information on application and approval dates is collected annually from pharmaceutical companies and regulatory authorities and is augmented by information from the published literature. Review and approval times are monitored for the USA, Europe  Canada, Australia and Switzerland.

The results and analyses have been published in a number of forms including a journal article, "A Comparison of the Drug Review Process at Five International Agencies." Drug Info J. 2007;41:291-308.