As part of the regulatory approval process for new drugs, innovator companies are required to disclose certain information — such as that related to ingredients, methods of manufacture, tests of potency, efficacy and safety, as well as details of possible contraindications and side effects — to the regulatory authority. This information is then reviewed by the regulator — the Canadian regulator is called Health Canada — which then releases a publicly available drug product monograph. Not all the information supplied to regulator will be in the monograph.

However, any interested party (and hence potential competitors) can request access to information held by Health Canada under the Canadian Access to Information Act (similar legislation exists in many other countries), which allows public disclosure of selected government information.

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