TPD/BGTD Frequently Asked Questions: Good Guidance Practices

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A. Good Guidance Practices

A1. What are Good Guidance Practices (GGP)?

Good Guidance Practices (GGP) are the definitions, procedures, and practices for the development, issuance and use of the various documents that provide guidance to TPD/BGTD staff and stakeholders.

A2. What is the scope of GGP?

GGP applies to the development of documents within TPD and BGTD that provide guidance to staff and stakeholders. GGP will build on the TPD and BGTD Policy Development Processes, and will have wider application. It will complement, not replace, the Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks.

A3. Who will use GGP?

All TPD and BGTD staff and contractors are responsible for using GGP in the development, issuance, and application of external documents.

A4. What is the purpose of GGP? Why is it important?

The purpose of GGP is to promote the appropriate development and application of guidance documents. Guidance documents will be consistent with relevant legislation, regulations and/or international commitments, will be developed with adequate participation internally and externally, and will be supported by an issue analysis summary documenting the development process.

B. Definitions

B1. What is the definition of a guidance document?

Guidance documents are official records providing information to assist external stakeholders (such as industry and healthcare professionals) in complying with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada's mandate and objectives should be implemented in a manner that is fair, consistent and effective.

B2. What are the types of guidance documents?

Guidance documents can generally be divided into two types: scientific/technical and regulatory/procedural. Scientific/technical guidance documents typically provide the basis for TPD/BGTD's interpretation of the requirements for safety, efficacy and quality of therapeutic products, and facilitate the preparation of submissions/applications for market authorization. Regulatory/procedural guidance documents typically outline processes to be followed by TPD/BGTD and stakeholders, in order to achieve Health Canada's mandate and objectives.

B3. Are Policies, Guidelines, and Policy Issues considered to be guidance?

Yes, they are guidance and are within the scope of GGP, and will be re-named guidance documents as they are revised. Historical terms such as policies, policy issues, and guidelines will no longer be used.

B4. Are Notices, Advisories, Fact Sheets, or Dear Healthcare Professional Letters guidance?

No, these documents are not guidance documents, and GGP does not apply to their development or issuance.

B5. Are Standard Operating Procedures guidance?

No. Standard Operating Procedures are informative records outlining the steps to be taken by TPD or BGTD staff to accomplish one or more specific tasks. Although intended as internal documents, they may be made publicly available in the interests of transparency.

B6. Should Templates or Forms be developed in accordance with GGP?

Yes. A guidance document may be accompanied by a template or form for completion by stakeholders; if so, the template or form should be developed concurrently with the guidance document, in accordance with GGP.

B7. What is a Directive? Should Directives be developed in accordance with GGP?

A Directive is issued by BGTD and advises a target audience of a policy decision or regulatory requirement that requires immediate action to address a specific risk issue. Directives are often issued as an interim measure pending the development of regulations. Directives will be developed in accordance with GGP.

B8. What do "draft" and "final" mean?

"Draft" means that the guidance document is being published for consultation, and may change prior to adoption. "Final" means that the document has been adopted by TPD/BGTD.

B9. What is an Issue Analysis Summary?

An Issue Analysis Summary (IAS) is a complete summary of the information and analysis gleaned from the issue analysis or guidance development process. It includes an analysis of the issue, the options identified, and the recommended option.

C. Legal Effect of Guidance Documents

C1. What is the legal effect of guidance documents?

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. They do not legally bind stakeholders or TPD/BGTD.

C2. Are alternate approaches to guidance documents acceptable?

Alternate approaches to the principles and practices described in guidance documents may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

C3. What is mandatory language, and when is it used?

Guidance documents will not include mandatory language such as "shall", "must", or "requirement", unless a statutory or regulatory requirement is being described. "Should" or "expected" are not mandatory language and may be used in guidance documents.

D. Guidance Development Process

D1. How does TPD/BGTD decide to proceed with guidance development?

When an issue is identified, a Project Lead will be identified and an issue analysis will be conducted to determine the most appropriate way to deal with the issue. Options could include a regulatory change, the development of a guidance document, the development of a communications or risk management piece (e.g. a Notice to Stakeholders, a Dear Healthcare Professional Letter, etc.), or no action. The result of the issue analysis will be an Issue Analysis Summary (IAS), which may be published on the website for consultation. It is reasonable to assume that the issue analysis associated with a detailed, scientific guidance document may be more straightforward than that associated with broader, more complex issues dealing with multiple areas of expertise.

D2. What are the significant steps in guidance document development?

When the development of a guidance document is chosen as the preferred option (see question D1), a Project Lead will be identified and an action plan will be prepared and approved. With the assistance of a working group as appropriate, the Project Lead will draft the guidance document and document the analysis conducted. The draft guidance document will undergo internal and external consultation before being adopted as a final guidance document.

D3. Is there an opportunity to expedite issue analysis and guidance development?

Yes. Urgent issues related to a critical health and safety matter may be developed using the expedited process, upon approval of the Management Committee(s) of the relevant Directorate(s). The process for expedited issue analysis and guidance development is similar to the full process, but will move in an expedited manner and may omit steps (e.g. it will likely not involve the full range of internal or external consultations). In the case of very urgent issues, related to a critical health or safety concern, prior public consultation may not be feasible and guidance documents may be published in final form for immediate implementation. A consultation period may follow publication; if so, comments will be analysed and revisions to the guidance document will be made as appropriate.

E. Stakeholder Input into the Guidance Development Process

E1. How can stakeholders participate in guidance document development?

Stakeholders may suggest topics for guidance development; these should be directed to the relevant program area. In some situations, stakeholders may be asked to participate actively in guidance development. Draft guidance documents will be formally published for consultation; in addition, stakeholders may comment on final guidance documents that have been implemented (see question E3).

E2. Will guidance documents always be published for consultation prior to implementation?

No. In the case of an urgent health or safety issue, guidance documents may be developed and issued according to the expedited procedure, and may be published for immediate implementation (see question D3). A consultation period may follow publication; if so, comments will be analysed and revisions to the guidance document will be made as appropriate.

E3. Can stakeholders comment on a final guidance document that has been implemented?

Yes. Comments should be directed to the Contact identified for each document. The Contact is responsible for receiving, reviewing, and responding to comments and questions about the guidance document. The Contact must keep a record of comments received; if there are significant concerns, the Contact may decide to revise the document (possibly outside of the normal review schedule).

E4. How will stakeholders know what guidance documents are available?

New guidance documents (draft and final) will be posted on the 'What's New' page of the Health Canada web sites for three weeks. They will also be available on the Health Canada website under 'Legislation and Guidelines' on the 'Drug Products' page and the 'Biologics, Radiopharmaceuticals, and Genetic Therapies' page.

E5. How will stakeholders know what guidance development is planned?

TPD/BGTD will often discuss upcoming guidance development at meetings with stakeholder groups, and upcoming consultations are posted on the Public Involvement Calendar found on the Health Canada website.

F. Review and Revision of Guidance Documents

F1. What is the normal review schedule for guidance documents?

TPD/BGTD will endeavour to review guidance documents every two years. The Contact will decide whether the guidance document as a whole is still relevant and necessary, and if so, will review it to determine whether any revisions are needed. The nature of the revision (administrative or significant) will determine the process to be followed. Timing of the revision will depend on TPD/BGTD priorities and available resources.

F2. Will revisions to guidance documents follow the guidance development process?

The process that will be followed to revise a guidance document will depend on the nature of the revisions. If the revisions are significant, the full guidance development process will be followed, including external consultation prior to implementation (unless revisions are as a result of an urgent health or safety issue, in which case the document may be revised and published for immediate implementation). If the revisions are administrative in nature, the full guidance development process will not be followed, and the document may be published without consultation.

F3. What revisions are considered to be administrative?

Administrative revisions will normally be limited to the following:

• updating a document when names, addresses, or organizations have changed;
• providing a clarification of current practice, which does not change the policy objectives or operational requirements of the document; and
• changing the format of the document (where the content does not change); the exception is a Template, where a change in format may affect staff or stakeholders and therefore will not normally be considered to be administrative.

Other revisions will normally be considered to be significant.