Confidentiality

As per the Confidentiality Guidelines for Scientific Advice , all documents submitted by the applicant and produced by Canada’s Drug Agency (CDA-AMC) as part of the Scientific Advice program are kept confidential between the applicant and CDA-AMC (including authorized recipients and patient representatives, as applicable).

In order to preserve the confidentiality of the applicant's information at this early stage of development, CDA-AMC does not disclose any documents submitted by the applicant or any information about the application, including the name of the drug or the name of the applicant, to potential experts or potential patient representatives until a Nondisclosure Agreement is signed.

Information Shared With External Experts

By applying to the Scientific Advice program, applicants are deemed to give permission to CDA-AMC to disclose information about their application, including applicant name, drug name, and documents submitted and produced as part of the Scientific Advice program, to experts who have signed a Nondisclosure Agreement.

Read more about expert involvement in the Scientific Advice program.

Information Shared With Patient Representatives

Patient input is part of the Scientific Advice program for all applications. However, documents submitted by the applicant or produced by CDA-AMC as part of the Scientific Advice program are shared with patient representatives only if permission is granted by the applicant and, in that case, only after a Nondisclosure Agreement has been signed by the patient representative. Applicants indicate permission to share information in the online application form for Scientific Advice.

Note that submission of the Patient Drug Information Form, an optional form completed by applicants as background information to patient representatives, constitutes the applicant's agreement for CDA-AMC to share the submitted form with patient representatives involved in the application.

Read more about patient involvement in the Scientific Advice program.

Information Shared Between Organizations Participating in Parallel Scientific Advice

By requesting parallel Scientific Advice, applicants are deemed to give permission to CDA-AMC to disclose and exchange information related to the project with the participating organizations. This includes but is not limited to the clarification questions and draft and final versions of the advice developed by each organization. Project staff from each organization may meet at multiple time points to discuss the Briefing Book and responses to the questions posed in the Briefing Book. Any information you provide to each party, in writing or otherwise, is subject to this exchange. Authorized recipients from participating organizations are required to comply with the applicable legislation, policies and confidentiality guidelines to which it is subject, including any freedom of information and access to information legislation.

Read more about confidentiality and information sharing in the Scientific Advice program.

Information Shared with CDA-AMC Staff

Within CDA-AMC, Scientific Advice files are kept in a secure location, with access restricted to CDA-AMC staff involved in the Scientific Advice program. CDA-AMC staff involved in the Scientific Advice program are permitted to share information across the organization, as deemed appropriate by CDA-AMC.

All experts, patient representatives, and CDA-AMC staff, privy to Scientific Advice information must comply with the Confidentiality Guidelines for Scientific Advice and the Conflict of Interest Policy for CDA-AMC Employees or Conflict of Interest Guidelines for CDA-AMC Contractors.

Read more about conflicts of interest related to the Scientific Advice program.