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Regulatory Comparison Table:
Differences in Regulatory Approval Process across Countries

As part of the 2015 update of the From Bench to Clinic webtool, regulatory experts from the United States, Canada, the United Kingdom, and South Africa helped develop a comparison table that offers a high level overview of the key differences in the regulatory environments in different parts of the world. Users who are unfamiliar with the regulatory approval process for Phase I trials, or only have experience with regulatory activities in one of the countries, can use the Regulatory Comparison Table as a resource to identify the areas that require a more careful assessment. While information in the table is kept concise to allow for a quick at-a-glance comparison, it provides reference links for more detailed information and additional resources. Investigators are encouraged to also consult the regulatory agency of their own country and the country they wish to conduct the trial in to ensure regulatory compliance and avoid delays and severe penalties.

If you would like us to include additional countries in this comparison, please send us a note to timelytopics@vaccineenterprise.org

Regulatory Comparison Table

If the table does not open when you click on the image, your popups and/or javascript is disabled in your browser. You can access the tool directly at, http://www.vaccineenterprise.org/timely-topics/regulatory-comparison/index.html

Acknowledgements

The Enterprise wishes to thank the following stakeholders for their contribution: Jim Ackland (Global Biosolutions/IAVI), Angus Cameron (Biological Consulting Europe), Simon Lewis (Medicines and Healthcare products Regulatory Agency, United Kingdom), Zinhle Makatini (National Health Laboratory Service, South Africa), Portia Nkambule (Medicines Control Council, South Africa), Helen Rees (Wits Reproductive Health and HIV Institute, South Africa), Tanya Scharton-Kersten (IAVI), Dean Smith (Health Canada), Carol Weiss (U.S Food and Drug Administration), and Devika Zachariah (IAVI).

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