Chapter 1: Guiding Principles

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The following Good Guidance Practices are to be followed by all Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) staff:

• Documents intended to provide direction to both stakeholders and staff must be published prior to external implementation and will be called guidance documents.
• Documents intended to provide direction primarily to staff will be called standard operating procedures; although intended as internal documents, these may be made publicly available in the interests of transparency.
• The issue analysis and guidance development processes will be open and transparent.
• Guidance documents will be consulted upon, both internally and externally, prior to implementation. The exception will be those guidance documents that are developed in response to an urgent issue (e.g. critical health or safety concern); prior public consultation may not be feasible and guidance documents may be developed according to an expedited process and published in final form for immediate implementation.
• Comments received during the consultative process will be addressed and answered in a document available, at a minimum, to those who were consulted.
• Guidance documents will normally be published for prospective implementation.
• Guidance documents will not remain in draft format indefinitely; TPD and BGTD will target to finalize guidances within one year of the close of the consultation period.
• Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in guidance documents may be acceptable provided they are supported by adequate justification. Deviations from the principles and practices described in a guidance document should be justified, documented, and taken into account in future revisions of the document.

Guidance documents published by TPD and BGTD will be:

Available and Accessible

• Guidance documents will be available in both English and French.
• Guidance documents will be written in plain or explicit language.
• Guidance documents will be easily accessible in a central electronic repository that includes an archive.
• Files associated with issue analysis and guidance development are complete and readily accessible to internal staff through good record keeping practices.

Consistent

• Guidance documents will be in accordance with applicable Acts and Regulations and Health Canada's objectives. They will contain policy objectives that outline how the document is in line with the relevant Act and Regulations and with the objectives of the Health Products and Food Branch (HPFB). Guidance documents will also describe the operational details related to the application of the policy objectives.
• Guidance documents should not contradict other documents.
• Guidance documents should be cross-referenced to avoid duplication of information.
• The approach taken in guidance documents should be harmonized with that of other jurisdictions, where possible.

Current

• Guidance documents will be subject to periodic review to determine whether the document is still relevant and necessary, and whether revisions are needed. TPD/BGTD will endeavour to review guidance documents every year.
• Guidance documents will be revised in accordance with Standard Operating Procedure (SOP) #3, Revisions to Published Documents in TPD/BGTD.

Supported

• Guidance documents will be reviewed by Legal Services where appropriate (for example, to ensure there is no contradiction with the Food and Drugs Act and Regulations).
• Guidance documents will be accompanied by an Issue Analysis Summary documenting the information gleaned from the issue analysis and guidance development processes.