Drug marketing: Application process
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These documents discuss the application processes for new drug approval in Canada, the US and Europe, as well as details about the clinical data requirements for new drug applications and chemistry, manufacturing and control requirements.
They are designed to help entrepreneurs gain an understanding of the scope of information a regulatory agency will look for when assessing the safety, efficacy and quality of a new drug.
Clinical Data Requirements for a New Drug Application (PDF)
How New Drugs are Approved in Canada (PDF)
How New Drugs are Approved in the US (PDF)
How New Drugs are Approved in Europe (PDF)
These articles are not intended to provide specific details, but to summarize the likely requirements that must be met before a new drug can be commercialized.
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