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Standard Operating Procedure (SOP) #2: Guidance Development in TPD/BGTD

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Standard Operating Procedure
TPD SOP Template WP Version 1: Effective Date 2006-04-01
Title
Good Guidance Practices WG
Doc. Number
GGP SOP #2
Version
2.0
Bureau / Office / Area
Good Guidance Practices WG
Status
Final
Effective Date
August 2007
Approved for external consultation by
TPD Management Committee
BGTD Management Committee
Date
July 27, 2007 (TPD-MC)
August 1, 2007 (BGTD-MC)

Table of Contents

1 Purpose

The purpose of this procedure is to provide the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) with an overview of the guidance development process. The output of this procedure will be the development of a guidance document, accompanied by documentation of the analysis conducted in creating the guidance document.

This procedure is to be followed after the issue identification and analysis outlined in Standard Operating Procedure (SOP) #1 (Issue Analysis in TPD/BGTD) has taken place, and the development of a guidance document has been chosen as the preferred option. It is also to be followed if consideration is being given to adopting a guidance document (in whole or in part) from another regulatory authority or organization (in Canada or in other jurisdictions).

Guiding Principles applicable to guidance development are outlined in Chapter 1 of the Good Guidance Practices (GGP) Manual.

2 Scope

This procedure applies to the development of all TPD/BGTD guidance documents, including those which are Bureau/Centre/Office-specific and those that may be adopted (in whole or in part) from another regulatory authority or organization (in Canada or in other jurisdictions). Guidance documents that will be developed through the full process should follow Section 5.1, while guidance documents relating to a serious health or safety risk will be developed through an expedited process described in Section 5.2.

All TPD and BGTD staff must adhere to this procedure, including employees and contractors working for the Directorate(s).

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, according to the same procedure. A guidance document may also be accompanied by a Frequently Asked Questions (FAQ) document, which supplements a guidance document and is used to clarify portions of the guidance document, or as a quick reference for issues that commonly arise. Throughout this procedure, the term guidance document includes an accompanying template, form or FAQ document if developed.

This document, together with SOP #1 (Issue Analysis in TPD/BGTD), supercedes A Reference Guide to Policy Development in the Biologics and Genetic Therapies Directorate, dated January 2003, and Policy Development in the Therapeutic Products Programme: A Reference Guide, dated May 1998.

3 Definitions

Definitions applicable to the guidance development process are outlined in Chapter 2 of the GGP Manual.

4 Responsibilities

Roles and responsibilities of those involved in the guidance development process are outlined in Chapter 3 of the GGP Manual.

5 Instructions

This procedure provides an overview of the steps involved in the guidance development process. This document is intended to accompany, not replace, the Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks.

Development of a guidance document will occur after issue identification and analysis have taken place in accordance with SOP #1 (Issue Analysis in TPD/BGTD) and the development of a guidance document has been chosen as the preferred option.

Included within this procedure are the steps appropriate to guidance document development. The process map attached as Appendix 1 describes the steps outlined in this procedure. The process is flexible in that one may move back and forth between steps or revisit steps based on available information.

It is recognized that the circumstances of each issue will be different and therefore this procedure allows for tailoring, depending on the complexity of the issue being considered. Judgement will need to be exercised in deciding on the appropriate level of effort for each step in the process.

Although this procedure identifies key milestones where management should be involved, it is highly recommended that management be updated regularly on the progress of the issue.

Consultations play a central role in guidance development and there are opportunities to involve staff and stakeholders in the process. Consultations should be effective, timely, open and transparent, and participants should have a clear understanding of their role and how their input will be considered. Included in this procedure are key steps at which formal consultations are recommended; however, consultation is an iterative process and there are opportunities to involve staff and stakeholders throughout the guidance development process. It is important that all consultations, whether they are considered formal or informal, are documented within the file.

In the following pages, steps of the process are described and detailed with respect to inputs, consultation, outputs, desired outcomes, references and templates. Questions to consider are also included, to establish minimum standards for how each step is approached and assist in tailoring a step to a particular issue.

Guidance documents will normally be developed in accordance with the full process outlined in Section 5.1. However, urgent issues related to a critical health and safety matter will arise and Directorates must have the ability to take action quickly. Guidance documents related to an urgent health and safety matter may be developed using the expedited process outlined in Section 5.2, upon approval of the Management Committee(s) of the relevant Directorate(s) (DMC). The decision to proceed according to the expedited process should be made as early as possible in the process; however, during the course of guidance development the urgency of the issue may change and at this point, the Management Committee(s) of the relevant Directorate(s) may decide to proceed in an expedited fashion.

This procedure may be terminated at any time, as a result of new information or changes in TPD/BGTD priorities or resource availability. In order for a project to be terminated, the Project Lead must obtain DMC approval to do so; once obtained, the Project Lead must document the reasons for termination (and the discussions at DMC) for the file.


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5.1 Guidance Development Process

The guidance development process in TPD and BGTD consists of two key analyses. The first is the identification and analysis of the issue of concern (as outlined in SOP #1 (Issue Analysis in TPD/BGTD), followed by the selection of one or more preferred options. Normally the Policy Objectives portion of the guidance document will arise from this analysis.

The second is the analysis of the operational details associated with the implementation of the policy objectives, as outlined in this procedure. Both sections (Policy Objectives and Guidance for Implementation) will be included in each guidance document to be published for implementation. However, as discussed in SOP #1 (Issue Analysis in TPD/BGTD), for complex and significant new issues it may be useful to consult on the Policy Objectives portion of the guidance document separately, prior to the development of the operational portions in this procedure.

It is possible for the two analyses to occur together: the exploration and analysis of various options may include consideration of the content (operational details) proposed for the guidance document. In this situation, the consultations, approvals and publication of the Issue Analysis Summary (IAS) and the guidance document may occur together.

Note also that it may be possible to work collaboratively on the development of a guidance document with one or more foreign regulatory agencies or organizations, or to adopt a document from another agency or organization (in whole or in part). If so, this procedure should still be followed to the extent possible (e.g. consultation will still take place with TPD/BGTD and with TPD/BGTD stakeholders).

Step 1 Assign Project Lead and Update Documents

The relevant DMC is responsible for ensuring that a lead has been assigned. In most cases, the Project Lead will have been identified when guidance development was approved by DMC(s) in SOP #1 (Issue Analysis in TPD/BGTD). The Project Lead for guidance development may or may not be the same Project Lead who was responsible for the issue analysis. For example, a policy analyst may have been the Project Lead for the issue analysis and a reviewer the Project Lead for guidance development.

The Project Lead will manage the project and will have overall responsibility and accountability (refer to Chapter 3 of this Manual for more information on roles and responsibilities). The Project Lead will not necessarily complete all steps him/herself, but will be responsible for ensuring each task is completed. The Project Lead is also responsible for record keeping throughout the guidance development process, in accordance with the Health Canada Records Management Policy (Reference #6).

If significant time has elapsed between issue analysis and guidance development, the Project Lead should review the current situation and update documents as necessary. The Project Lead should consult with the International Programs Division (IPD), TPD or the Business Integration Office (BIO), BGTD to determine whether similar work has been undertaken, or is ongoing, internationally. If so, IPD/BIO may become more actively involved or may assume the Project Lead. A procedure for ICH guideline development and implementation is in progress; for more information, contact IPD. Guidance development may not stop here; the objectives of the international document may not meet Canadian needs, especially if the document has not been defined in the Canadian context. Alternatively, it may be possible to work collaboratively with another agency or organization on the development of a guidance document.

The Project Lead should also review the Action Plan for implementation, approved by DMC(s) in SOP #1 (Issue Analysis in TPD/BGTD), to determine if it is sufficiently detailed and still relevant. If not, the Project Lead should revise the Action Plan and discuss with the Lead Director/Senior Manager whether it is necessary to return to DMC(s) for review and approval (the process outlined in Step 6 should be followed for review by DMC).

The Action Plan should outline all the sub-projects that may feed into the process. Sub-projects can include, but are not limited to: Compliance and Enforcement, Legal Authority and Tools, Communications/Consultations and/or Public Involvement Plans, and Evaluation. These sub-projects may also help to divide the work between various areas of expertise; for a large project, an Action Plan may be drafted for each sub-project and accompany the Action Plan for the over-arching project.

The Action Plan is used to describe and obtain agreement on the resources (internal and external) required to draft the guidance document. The Action Plan will also provide the Project Lead with the rationale to request participation from other Bureaux/Centres/Offices, Directorates, Branches and/or Departments, depending on the scope of the issue and the expertise required.

The Action Plan will clearly outline the roles and responsibilities of those to be involved in the project. For example, if the Project Lead is a content expert but may require assistance with process, a policy resource should be identified, or, if the Project Lead is a process expert the Action plan should identify needed content expertise. The expertise may be provided as part of a working group formed, or be available for assistance as needed.

The Project Lead should revisit the Action Plan regularly throughout guidance development, to ensure no steps have been missed and verify whether the project is proceeding according to the timeframes predicted. Significant changes may require review and approval by DMC.

In developing a Communications/Consultation Plan, attention should be paid to choosing the right mechanism for informal and formal consultation, timing, selecting the right participants, and budgeting accurately. For assistance with Communications/Consultations and/or Public Involvement Plans, consult the Promotion and Consultation Unit (BGTD) or the Public Involvement Network representatives (TPD). Documents to assist with public involvement are available on the HPFB Intranet.

Questions To Consider:

  • Is the choice of Project Lead clear?
  • Is there anything on this issue being developed internationally? Does the international document address the issue(s) identified? How applicable is it to Canadians?
  • Is there an opportunity for TPD/BGTD to collaborate with another regulatory agency or organization (in Canada or in other jurisdictions)?
  • Has consideration been given to adopting a document (in whole or in part) from another regulatory authority or organization (in Canada or in other jurisdictions)?
  • Is the Action Plan approved in SOP #1 (Issue Analysis in TPD/BGTD) sufficiently detailed and still relevant?
  • Who are the stakeholders? Who will be consulted and at what stages?
  • Has a Communications/Consultations and/or Public Involvement Plan been drafted?
  • Has the Promotion and Consultation Unit (BGTD) or the Public Involvement Network representatives (TPD) been notified of proposed consultation activities, and/or involved in the development of a Public Involvement Plan?

Inputs: IAS and Action Plan for implementation from SOP #1 (Issue Analysis in TPD/BGTD).

Consultation: IPD, TPD or BIO, BGTD. Lead Director/Senior Manager and management. For advice on Communications/Consultations and/or Public Involvement Plans, consult the Promotion and Consultation Unit (BGTD) or the Public Involvement Network representatives (TPD).

Outputs: Confirmation about work ongoing domestically or internationally. Updated and approved Action Plan. Updated and approved Communications/Consultations Plan and/or Public Involvement Plan as needed.

Desired Outcomes: Action Plan is up to date and management has current information needed to make a decision on the path forward.


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Step 2 (Optional) Form Working Group

The Project Lead may choose to form a working group to assist with guidance development. A working group will often be formed when an issue touches on several areas within a Directorate, or several Directorates; it will provide a mechanism to obtain input from various areas within the affected Directorate(s) and will facilitate internal communication.

If a working group was formed earlier in the process to support the issue analysis, it may be appropriate that the same group continue drafting the guidance document. The Terms of Reference, tenure and membership of the working group may need to be revisited. If a new working group is to be formed, this will have been identified in the Action Plan approved by DMC(s).

For cross-Directorate issues, the level of participation decided by the affected DMC(s) will determine whether a request for working group representatives should be sent to that Directorate.

If it is anticipated that significant issues will arise during the course of guidance development, it may be useful to request a representative from Health Canada Legal Services. This representative would be a full working group member and provide Legal Services input as needed throughout guidance development.

The Project Lead will normally chair the working group and will be responsible for its effective management. The working group Chair will draft the Terms of Reference for the group; among the group's first tasks should be a review and endorsement of the Terms of Reference and Action Plan. The Terms of Reference will outline the roles and responsibilities of the working group members, including various tasks that may be delegated to members by the Chair. Roles and responsibilities must also be defined with regards to the role of working group members as liaisons with their respective areas (Bureau/Office/Centre, Directorate, Branch, etc.). For example, working group members are normally responsible for updating the management within their Bureau/Office/Centre (or Directorate), obtaining management approvals from their area as needed, and bringing any management concerns back to the working group table.

Questions To Consider:

  • Was a working group formed to assist with issue analysis? If so, can it continue and assist in drafting the guidance document? If so, do the Terms of Reference, tenure or membership need to be revisited?
  • What kind(s) of expertise is/are needed? What level of representation is needed on the working group? What time commitment will be required from working group members?
  • Should a representative from Health Canada Legal Services be requested?
  • How will the working group be managed? How will key decisions be made (e.g. consensus, majority, etc.)?
  • What are the responsibilities of working group members?

Inputs: Action Plan.

Outputs: Terms of Reference of working group and Action Plan.

Desired Outcomes: Guidance development is inclusive and internal communication is facilitated. The guidance development process is open and transparent.

Templates (Chapter 5 of GGP Manual): Terms of Reference, Agenda, Meeting Notes.

Step 3 Draft Guidance Document

In the remaining sections of this procedure, the term Project Lead refers to the Project Lead with the input of the working group if one is formed.

It is the responsibility of the Project Lead to draft the guidance document using the templates included in Chapter 5 of this Manual. The Publications Unit (TPD) or Website Coordinator (BGTD) will provide assistance with formatting as needed throughout the process.

The key options analysed and decisions taken during the development of the guidance document (e.g. specific requirements for a drug submission or medical device application sponsor, specific steps of the process to be followed, etc.) must be documented. This can be done via meeting notes or notes to file that are kept with the corporate record for the guidance document. Alternatively, it may be useful to provide the decisions and rationale to those being consulted (internally/externally), in which case they may be appended to the IAS developed in SOP #1 (Issue Analysis in TPD/BGTD), or included in a new IAS specific to the guidance development. Judgement will be necessary to determine the amount of detail required, keeping in mind the need to document the rationale for key decisions made.

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.

Consultations play a central role in the guidance development process. The degree of internal and external consultations to be undertaken will have been outlined in the Action Plan approved by DMC. A Communications/Consultations Plan and/or Public Involvement Plan may have been drafted earlier and may be revisited throughout this step as the issue develops.

The consultation effort should be proportional to the magnitude and/or complexity of the issue and should generally occur as soon as possible into guidance development. Formal consultations held only after key decisions are made are not likely to be effective in achieving commitment and 'buy-in' from staff or stakeholders. Although formal consultations are essential to the process, informal consultations are also valuable and there are opportunities to involve staff and stakeholders in all stages of the guidance development process. All consultations, whether they are considered informal or formal, must be documented within the file.

At any time during the guidance development process, the Project Lead may consult with Directorate-, Branch- or Department-level committees to seek their opinion on scientific issues encountered. External parties (including Scientific Advisory Committees) may also be consulted. The Project Lead may also seek input on associated socio-economic or ethical issues when they seem pertinent. It may be advisable for the Project Lead to discuss this matter with the working group and Lead Director/Senior Manager first.

The Project Lead should contact Legal Services to discuss whether an in-depth legal opinion is needed. It is crucial to ask the 'right' question: one that explains the options considered and outcomes sought, as well as the need to know how to achieve these outcomes within the constraints of the applicable legislative framework. If a representative from Legal Services is on the working group formed in Step 2 of this procedure, it would be his/her role to provide this information.

Along with the guidance document, the Project Lead will develop an Implementation Plan including a proposed effective date, a training plan and a plan for the promotion or communication of the launch of the document, if appropriate. Comprehensive Implementation Plans are critical, and must take into account how operational plans and resources might need to be adjusted once the final guidance document is implemented.

Throughout this step, the Project Lead should consider the need for an evaluation to determine whether the objectives set at the early stages of issue analysis have been met. To prepare for the evaluation, criteria will be identified throughout the process and formalized into an Evaluation Plan.

The Project Lead should revisit the Action Plan to ensure no steps have been missed and verify whether the project is proceeding according to the timeframes predicted. Note that significant changes may require review and approval by DMC.


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Adoption of a Guidance Document from Another Regulatory Agency or Organization

A procedure for ICH guideline development and implementation is in progress; for more information, contact IPD.

During issue analysis and guidance development, the Project Lead should examine the regulatory practices and guidelines of other regulatory authorities or organizations (in Canada or in other jurisdictions), with a view to moving to greater compatibility. As described in the Guiding Principles (Chapter 1 of this Manual), the approach taken in guidance documents should be harmonized or aligned with that of other jurisdictions, where possible. The Project Lead should document the analysis and rationale behind the recommendation to either follow an approach of another organization, or pursue a TPD/BGTD-specific approach.

In some situations, the analysis conducted in SOP #1 (Issue Analysis in TPD/BGTD) may result in a decision to adopt a guidance document (in whole or in part) from another regulatory authority or organization (in Canada or in other jurisdictions). Adopting a guidance document from another jurisdiction means that all or portions of an existing document published by another regulatory authority or organization may be are incorporated into a new (or revised) Health Canada guidance document.

The Project Lead should consult with IPD, TPD or BIO, BGTD when consideration is being given to the adoption of a guidance document from another jurisdiction. Legal Services may also be consulted, to verify that the document does not contradict Canadian regulatory approaches.

Note that the guidance document produced may be a combination of portions adopted from another agency(ies) or organization(s) and new text drafted. When reviewing portions of the document to be adopted from another regulatory authority or organization, the Project Lead should make revisions to be consistent with TPD/BGTD terminology and relevant legislation. The guidance document must be consistent with applicable legislation, regulations, and Health Canada's mandate and objectives. The Project Lead should carefully review the Questions to Consider outlined below on International Considerations in addition to the other Questions.

The guidance document produced will be a Health Canada guidance document and will continue through the remaining steps in the process, including internal and external consultations. The Project Lead should ensure that the fact that the guidance document is based (at least in part) on a document from another regulatory authority or organization (in Canada or in other jurisdictions) is made clear throughout the remainder of the process.

Questions To Consider:

  • What are the constraints to action, e.g. of a technological, social, political, environmental, legislative/ regulatory, policy, ethical or fiscal nature?
  • Are all components of the guidance document feasible, i.e. there are no unreasonable health, economic, social, ethical, political or legal implications?
  • Is the guidance document grounded in and consistent with TPD/BGTD authorities, and with applicable Legislation, Regulations and/or guidance documents?
  • What are the risks associated with the guidance document (risk of non-effectiveness, risk of unintended effects, political, reputation or business risks)?
  • Has Legal Services been consulted?
  • Has the Promotion and Consultation Unit (BGTD) or the Public Involvement Network representatives (TPD) been notified of proposed consultation activities and/or involved in the development of a Public Involvement Plan?
  • Have innovative approaches to drafting the guidance document been considered, to maximize participation (internally and externally) and early consultation?
  • Have the key decisions and rationales been documented?
  • Has the least burdensome but effective alternative for business been recommended?
  • Have the objectives of the guidance document been stated clearly enough so that a post-implementation evaluation will be able to determine the degree of success achieved?
  • Has non-mandatory language been used in the guidance document?
  • Would the guidance document benefit from an accompanying template, form, or Frequently Asked Questions document?
  • Have additional terms been added to the Lexicon as needed?
  • Has the Style Guide been followed?
  • Has the guidance document template been used?

Implementation:

  • Has an Implementation Plan been drafted?
  • What will be needed to implement the guidance document?
  • Would a template or form be useful to stakeholders
  • How should the guidance document be promoted/communicated internally and externally?
  • What training (internal and/or external) will be required?
  • Is a phased-in implementation appropriate for this guidance document?
  • What resources are needed to implement this guidance document? Do operational plans need to be adjusted?

International Considerations:

  • What lessons can be learned from the experience of other regulatory authorities or organizations (in Canada or in other jurisdictions)?
  • Are there documents from other jurisdictions that may address the issue(s) identified?
  • Have IPD, TPD or BIO, BGTD been consulted?
  • Have the analysis and rationale behind the recommendation to either follow an approach of another regulatory authority or organization (in Canada or in another jurisdiction), or pursue a TPD/BGTD-specific approach been documented?
  • If a document from another regulatory authority or organization is to be adopted (in whole or in part), consider the following:
    • Is the document consistent with applicable legislation, regulations, and Health Canada's mandate and objectives?
    • Does the document contradict domestic guidance documents?
    • Has the document been drafted as a Health Canada guidance document, using TPD/BGTD templates?
    • Has the document been revised to use TPD/BGTD terminology, and to ensure it does not contradict domestic legislation, regulations, or guidance document

Inputs: Action Plan; IAS drafted in SOP #1 (Issue Analysis in TPD/BGTD); any documentation or data available relating to the development of the guidance document.

Consultation: Staff or management familiar with the issue. External stakeholders may be consulted to help draft the guidance document. For advice on Communications/Consultations and/or Public Involvement Plans, consult the Promotion and Consultation Unit (BGTD) or the Public Involvement Network representatives (TPD). For assistance with international considerations, consult IPD, TPD or BIO, BGTD.

Outputs: Draft guidance document and documentation of key decisions and supporting rationale. Draft Implementation Plan. Draft Evaluation Plan (if applicable).

Desired Outcomes: The guidance development process is open and transparent. All aspects of the issue are thoroughly understood. The drafting of the guidance document is facilitated by full consideration of the options available.

Templates (Chapter 5 of GGP Manual): Draft Guidance Document, Implementation Plan.

Step 4 Review and Approve Draft Guidance Document for Internal Consultation

Management approvals will be based on the draft guidance document and the Implementation Plan (and the Evaluation Plan if applicable).

The Lead Director/Senior Manager will review the draft guidance document and supporting documentation, and decide whether to approve the documents for implementation. Note that Lead Director/Senior Manager approval is sign-off of both process and content. The Director may request that the Project Lead revise the draft guidance document; significant revisions may require detailed analysis and documentation.

In some situations it may be necessary to obtain DMC approval prior to consulting internally, particularly for guidance documents with significant impact. This will have been included in the Action Plan and discussed and decided upon by DMC. If DMC approval is required, the Project Lead should follow the process outlined in Step 6 of this procedure.

Questions To Consider:

  • Have the main stages and decision points of the process been documented?
  • If the Director has recommended significant changes to the guidance document, have the changes and the rationale been documented?
  • Has the guidance document template been used?
  • Has non-mandatory language been used?
  • Have additional terms been added to the Lexicon as needed?
  • Has the Style Guide been followed?

Inputs: Draft guidance document, Implementation Plan, Evaluation Plan (if applicable), and documentation of key decisions and supporting rationale.

Outputs: Approved draft guidance document and Implementation Plan (and Evaluation Plan if applicable).

Desired Outcomes: Decisions on guidance documents are expedited and well informed


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Step 5 Consult Internally and Revise Documents

The Project Lead will distribute the guidance document internally for comment via e-mail to affected staff and DMC members (of each affected Directorate). DMC members are responsible for forwarding the document to those people or unit(s) within their area who should provide input. The e-mail will include contact information for the Project Lead, to whom comments and questions should be addressed, as well as a deadline for providing comments. The standard internal comment period is 30 days, however a longer comment period may be needed where the impact of the guidance document is expected to be high.

The Project Lead may consider conducting discussion sessions or presentations to staff to more actively solicit feedback on the documents.

The Project Lead will review all comments received, analysing each to determine whether a change will be made to the guidance document. Comments that are not relevant to this issue will be referred to the relevant area for possible action.

A key guiding principle, outlined in Chapter 1 of this Manual, is that all comments received during the consultative process should be addressed in a document available to those who were consulted. Therefore, the Project Lead will summarize the comments received and the rationale for acceptance or non-acceptance; this can be documented in section 5.1 of the IAS (Internal Consultations) or a summary table of internal consultations. The summary of consultations should be provided, along with the revised guidance document, to those who provided comments on the draft (at a minimum).

Note that if extensive comments are received, necessitating significant revisions to the documents, an additional round of internal consultations may be required.

The Project Lead will make changes to the draft guidance document as appropriate and will forward the document to the Publications Unit (TPD) or Website Coordinator (BGTD). The Publications Unit/Website Coordinator will perform a quality check of the documents (including formatting, consistency, compliance with Treasury Board and Health Canada policies related to publications, etc.) and prepare the documents for posting. The Publications Unit/Website Coordinator will return the documents to the Project Lead for approval; once approved, the Project Lead will forward the documents to the Lead Director/Senior Manager.

The Project Lead should revisit the Action Plan to ensure no steps have been missed and verify whether the project is proceeding according to the timeframes predicted. Note that significant changes may require review and approval by DMC.

Questions To Consider:

  • Have all affected staff had the opportunity to comment?
  • Have comments been addressed?
  • Has the guidance document been revised appropriately as a result of comments received?
  • Have any comments that do not relate directly to this issue been forwarded to the relevant area for possible action?
  • Is the level of consultation proportional with the expected degree of impact of the issue?
  • Have the participants been provided with the summary of consultations and the revised guidance document?

Inputs: Comments received from internal consultation.

Consultation: Documents will normally be sent to affected staff and DMC members of each affected Directorate for comment.

Outputs: Revised draft guidance document and summary of results of internal consultation (section 5.1 of IAS or summary table of consultations).

Desired Outcomes: Guidance development is improved by input from affected areas. Comments received during the consultative process are addressed in a document available to those who were consulted.

Templates (Chapter 5 of GGP Manual): IAS, Summary of consultation comments received.

Step 6 Review and Approve Draft Guidance Document for External Consultation

As in Step 4 of this procedure, the Lead Director/Senior Manager will review the completed guidance document and supporting documentation (including Implementation Plan and Evaluation Plan (if applicable)) and may suggest revisions to the Project Lead. When the Lead Director/Senior Manager is satisfied with the documents, he/she will sponsor the item to DMC.

A formal request should also be placed to have the documents presented to the Management Committee of every other affected Directorate (if a working group was formed, the representative(s) from the other Directorates will normally sponsor the item).

The draft guidance document and Implementation Plan must be sent to DMC(s) one week prior to the Management Committee meeting, along with any other documents (e.g. Evaluation Plan if applicable, Agenda Item Summary, presentation slide deck). The Publications Unit (TPD) or Website Coordinator (BGTD) must be copied on the documents, as must the Manager of IPD (TPD) or of BIO (BGTD), to ensure consistency with ongoing international initiatives.

The Project Lead and the Director will present an overview of the draft guidance document to DMC for consideration; DMC will be asked to approve the guidance document for external consultation. The Project Lead is responsible for incorporating suggested changes into the documents.

When DMC(s) has approved the draft guidance document and Implementation Plan, the date of the last Management Committee approval becomes the Approval Date recorded in the meeting notes. When approval is granted, it is the responsibility of DMC members to communicate to their Bureau/Centre/Office the progress on the issue.

Questions To Consider:

  • Have the Lead Director/Senior Manager and DMC(s) provided input on the draft guidance document and Implementation Plan?
  • If the Lead Director/Senior Manager or DMC(s) have recommended significant changes to the draft guidance document and/or Implementation Plan, have the changes and the rationale been documented?

Inputs: Completed draft guidance document and supporting documentation.

Outputs: Approved draft guidance document to be distributed externally for comment.

Desired Outcomes: Decisions on guidance documents are expedited and well informed.

Step 7 Consult Externally, Revise Documents, and Approve Final Guidance Document

The Communications/Consultations Plan will outline the mechanisms for consulting on the draft guidance document; in addition, the Public Involvement Plan may outline other methods of interacting with, or informing, stakeholders about the issue.

External consultations will normally be conducted via webposting. The Project Lead will arrange for the documents to be posted to be translated and will ensure that the translated versions are verified and match the original. The Project Lead will complete any additional documents needed (as identified by the Publications Unit (TPD) or Website Coordinator (BGTD)) and forward them to the Publications Unit/Website Coordinator.

The Publications Unit/Website Coordinator will coordinate the posting of documents with the webmaster; it is the Project Lead's responsibility to coordinate the distribution of announcements to stakeholders, either through the Director General's Office of each affected Directorate or another unit or area as appropriate. On occasion, other regulatory authorities or organizations (in Canada or in other jurisdictions) may be encouraged to provide comments.

A template for the submission of comments by stakeholders is included in Chapter 5 of this Manual and may accompany the published documents.

The standard external comment period is 60 days. A longer comment period may be appropriate if the guidance document is anticipated to have significant impact on stakeholders, or a number of documents are being posted for comment from the same stakeholders. A shorter comment period may be warranted if the issue is urgent or if the impact on stakeholders is not expected to be significant. Rationale for a shorter comment period should be explained in the Notice to Stakeholders that accompanies the published document(s).

The Project Lead may wish to present the issue to meetings or workshops with stakeholders, to more actively solicit feedback on the guidance document. In addition, as appropriate, the Project Lead may meet with stakeholders to discuss aspects of the documents, particularly in response to specific concerns or divergent views, or upon request.

The Project Lead will review all comments received, analysing each to determine whether a change will be made to the guidance document. Comments that are not relevant to this issue will be referred to the relevant area for possible action.

A key guiding principle, outlined in Chapter 1 of this Manual, is that all comments received during the consultative process should be addressed in a document available to those who were consulted. Therefore, the Project Lead will summarize the comments received and the rationale for acceptance or non-acceptance; this can be documented in section 5.2 of the IAS (External Consultations) or a summary table of internal consultations.

Comments may be published, in detail or in summary, unless they contain confidential information and the person commenting has specifically objected to the disclosure of this confidential information.

The summary of consultations may be published along with the final guidance document; alternatively, it should be provided to those who commented and available upon request for other interested parties (this should be indicated in the Notice to Stakeholders accompanying the final guidance document).

Note that if extensive comments are received, necessitating significant revisions to the documents, an additional round of internal and/or external consultations may be required.

The Project Lead will make changes to the guidance document and supporting documentation as appropriate and will forward them to the Lead Director/Senior Manager for review. Step 6 (review of the document and approval for implementation) will be repeated before proceeding to Step 8. The presentation(s) to DMC(s) will likely focus on changes to the guidance document as a result of external consultations and will ask DMC to approve implementation of the guidance document.

Questions To Consider:

  • Is the level of consultation proportional to the expected impact of the issue? Is the comment period appropriate?
  • Has the scope of the subject under consultation been defined? Are the expectations of all parties clear?
  • Have all affected stakeholders had the opportunity to comment?
  • Have all comments been addressed?
  • Have the documents been revised appropriately as a result of comments received?
  • Have any comments that do not relate directly to this issue been forwarded to the relevant area for possible action?

Inputs: Approved guidance document, Implementation Plan, Communications/Consultations Plan and/or Public Involvement Plan as needed.

Outputs: Revised guidance document and summary of results of external consultation (section 5.2 of IAS or summary table of consultations).

Desired Outcomes: Guidance development is improved by input from affected areas. The guidance development process is open and transparent. Comments received during the consultative process are addressed in a document available to those who were consulted.

References: Reference #1, #2, #5, #7, #8, #10 (Part II).

Templates (Chapter 5 of GGP Manual): Final Guidance Document, Issue Analysis Summary, Table for submission of comments, Summary of consultation comments received.


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Step 8 Publish and Implement Final Documents

Documents must be published in accordance with the process outlined by the Publications Unit (TPD) or Website Coordinator (BGTD).

As with every document posted, the Publications Unit/Website Coordinator will set up a standard review cycle for the guidance document, normally two years from publication. The Project Lead will ensure a Contact is identified for the guidance document, to whom comments will be directed; in addition, a generic e-mail address should be identified for posting. The Publications Unit/Website Coordinator will enter this information into the Metatag Database.

Implementation should proceed according to the Implementation Plan drafted. This may include training sessions (internal and/or external), communications pieces, adjustment of operational plans to appropriately align resources, etc.

Templates (Chapter 5 of GGP Manual): Final Guidance Document.

Step 9 Review Guidance Document

The Contact is responsible for receiving, reviewing and responding to comments and questions regarding the guidance document. The Contact must keep a record of comments received; if there are significant concerns with the guidance document, the Contact may decide to review and possibly revise the document. The standard review period is two years; at the end of this time, 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. Alternately, if significant new issues arise, it may be necessary to re-analyse the issue and selected option, and therefore to revise the document, outside of the normal review schedule. Refer to SOP #3 (Revisions to Published Documents in TPD/BGTD) for more information on revising published documents.

If the guidance document is no longer relevant and necessary and is to be removed from the website, a Notice to Stakeholders will be drafted to provide the rationale for the removal of the document. This will be posted in place of the guidance document for at least six months.

Questions To Consider:

  • Is the Contact aware of the responsibilities for document maintenance?
  • Have issues arisen on implementation that may necessitate a revision to the guidance document?
  • Is the guidance document still relevant and current?
  • Does the guidance document need to be revised?

Inputs: Published guidance document. Any comments or questions received pertaining to the documents.

Outputs: Responses to questions and comments received on the guidance document.

Desired Outcomes: Staff and stakeholders continue to provide input on TPD/BGTD documents. Published documents are subject to periodic review to determine whether they are still relevant and necessary, and whether revisions are needed.

Step 10 Evaluate Guidance Document

At an appropriate time after the implementation of the guidance document, an evaluation of whether the issue originally identified has been solved, and the continued relevance and effectiveness of the guidance document in addressing the issue, should be undertaken. This will be based on an outcomes model whereby expected outcomes are developed, outcome measures are designed, data relative to those measures are collected and an evaluation of those data is conducted at predetermined time points following implementation. The evaluation should take place in accordance with the Evaluation Plan drafted in the issue and guidance development processes, as per the criteria identified.

If the evaluation determines that the guidance document needs revision, the Contact will inform the Lead Director/Senior Manager and follow the process outlined in SOP #3 (Revision to Published Documents in TPD/BGTD).

The evaluator will determine whether any significant new issues have emerged; these may then be put through the issue analysis process outlined in SOP #1 (Issue Analysis in TPD/BGTD).

Questions To Consider:

  • Has an evaluation framework been developed that describes what elements need to be assessed, how the evaluation should be done and what data need to be collected to allow for an effective evaluation?
  • Have any new issues emerged or been created as a result of the implemented option?

Inputs: Published guidance document. Evaluation Plan. Any comments or questions received pertaining to the documents.

Outputs: Evaluation report. Revised guidance document (as needed).

Desired Outcomes: Guidance documents are periodically evaluated to determine their effectiveness at resolving the issue originally identified.

References: Reference #2, #3 (Section 2.6), #7, #10 (Part II).

5.2 Expedited Guidance Development Process

In urgent or critical situations, it is imperative that Health Canada take decisive action; this must be balanced with the Directorates' commitment to the principles outlined in Chapter 1 of this Manual.

In order to qualify for the expedited process, issues must be related to a critical health or safety concern and receive DMC approval for the guidance development to be expedited. Other situations where the expedited process may be appropriate include a response to a court decision or report from the office of the Auditor General. The process for expedited guidance development is similar to that outlined in Section 5.1, but will move in an expedited manner and may omit certain steps; for example, it will likely not involve the full range of internal or external consultations described in Section 5.1. The justification for the expedited process will be included in the Notice to Stakeholders accompanying published documents.

The decision to proceed via an expedited process will normally be made by DMC when guidance development is approved as the recommended option for implementation in SOP #1 (Issue Analysis in TPD/BGTD). The Project Lead will also typically have been identified at this point. If the issue is extremely urgent, the preparation of an Action Plan is not necessary and DMC approval will be considered to be given when guidance development is approved by DMC in SOP #1 and assigned.

The Publications Unit (TPD) or Website Coordinator (BGTD) should be contacted as early in the process as possible, to make the necessary preparations to publish documents resulting from the process.

The Project Lead may form an ad-hoc working group (Step 2 of the process outlined in Section 5.1) to assist with expedited guidance development. Due to the urgent nature of the issue, formal documents such as Terms of Reference are not necessary.

It is recognized that in urgent situations it is important to take fast, decisive action to provide guidance on the issue of concern. However, for future reference the Project Lead must make every attempt to document key decisions made and the rationale for those decisions. These may form the basis of an IAS; in the expedited process, a shortened version of the template in Chapter 5 of this Manual may be utilized.

Where possible, the Project Lead will consult internally with affected areas of the affected Directorate(s) in analysing options and making decisions. Directorate-, Branch- or Department-level committees or external Scientific Advisory Committees may be a valuable resource to seek input internally on key scientific issues; this will also serve as a form of consultation. Those stakeholders that will be most affected by the guidance document may also be consulted where appropriate and feasible.

Given the urgency of the situation, it may not be possible to undergo full internal and/or external consultations, and documents may be published for immediate implementation. In this situation, the Project Lead should consider undertaking full internal and external consultations after implementation. As in Section 5.1, the Project Lead is responsible for analysing responses received, making changes to the guidance document as appropriate and ensuring the necessary management approvals are obtained.


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6 Reference Documents

6.1 References

  1. Communications and Consultations Secretariat. Consultation Guidelines for Managers in the Federal Public Service, 1992. Available on the Privy Council Office website.
  2. Health Canada. A Reference Guide to Legislative Instruments - Biologic and Genetic Therapies Directorate, Draft 2005. (Internal document)
  3. Health Canada. Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks, 2000. Available on the Industry Canada Strategis website.
  4. Health Canada. Model Process for Managing Risk Issues in the Biologics and Genetic Therapies Directorate, 2002. (Internal document)
  5. Health Canada. Public Involvement Framework and Guidelines. Minister of Public Works and Government Services Canada, 2000.
  6. Health Canada. Records Management Policy, 1998. (Internal document)
  7. Health Canada. Regulations, Legislation, and Standards - A Recipe for Success, 2002.
  8. Privy Council Office. Guidelines for Effective Regulatory Consultations. Available on the Government of Canada Regulation website.
  9. Treasury Board of Canada Secretariat. Assessing Regulatory Alternatives, 1994. Available on the Privy Council Office website.
  10. Treasury Board of Canada Secretariat. Federal Regulatory Process Management Standards Compliance Guide, 1996. Available on the Privy Council Office website.

6.2 Templates

The following templates are located in Chapter 5 of the GGP Manual:

  • Action Plan
  • Agenda
  • Communications/Consultations Plan
  • Draft Guidance Document
  • Final Guidance Document
  • Implementation Plan
  • Issue Analysis Summary
  • Meeting Notes
  • Notice to Stakeholders
  • Public Involvement Plan
  • Summary of Consultations Table
  • Table for Submission of Comments
  • Terms of Reference

7 Authors

TPD/BGTD Good Guidance Practices Working Group.

8 Document Revision History

Version Change Made Effective
Date
1 Initial issuance of document for internal consultation September 2005
1.1 Revisions after internal consultation. April 2006
1.2 Revisions after DMC discussion. Issuance for external consultation May 2006
1.3 Revisions after external (and internal) consultation. April 2007
2.0 Final version posted. August 2007

Appendix 1: Process Map - Guidance Development Process

Process Map - Guidance Development Process

Date Modified: 2007-10-31

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Important Notices