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Good Guidance Practices Manual
Summarised Comments and Recommendations from External Consultations
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The draft Good Guidance Practices (GGP) Manual was generated by the GGP Working Group, to address one component of its mandate: to make recommendations for definitions, procedures, and practices for the development, issuance and use of the various documents that provide guidance to the staff and stakeholders of the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD).
The draft GGP Manual was published on the TPD/BGTD websites on August 18, 2006, for a consultation period to end October 13, 2006. Two sets of comments were received, both from innovator pharmaceutical companies. Several internal comments have also been received since the publication of the draft GGP Manual. The following is a summary of the internal and external comments received, together with discussions and recommendations for revisions.
The comments are excerpts from the original responses. Issues in the "Comment Received" column are discussed when the comment first appears, or, in some cases, where the issues are most applicable. The comment is not repeated when it or a similar comment appears later in the document.
Note that suggestions for editorial changes to the document have not been included in the summary below, although the changes were made.
| Section | Comment Received | HC Discussion and Recommendation |
|---|---|---|
| General comments | ||
| All guidance documents and review practices used by review staff should be posted to the website as a notice before internal implementation. (External) | As per the Guiding Principles, guidance documents will be posted to the website prior to implementation. Increasingly, review practices are documented in Standard Operating Procedures (SOPs), which are considered to be internal documents and may not be posted prior to implementation. However, SOPs may be (and several have been) posted to the website in the interests of transparency. Note that SOPs are outside the scope of GGP. No change made. | |
| Where the expedited issue analysis and guidance development processes are used, the internal and external consultation processes should still be conducted (prior to implementation), in an expedited fashion. (External) | The use of the expedited processes for issue analysis and guidance development is intended to be limited, and restricted to the urgent or critical situations described in the Manual. This is consistent with the government's ability to publish regulatory change directly to Canada Gazette Part II (without consultation in Canada Gazette Part I) in certain situations. Comments will be solicited after implementation and may result in changes to the document, however TPD/BGTD must have the ability to act quickly and decisively in certain situations. The review period for final guidance documents will be shortened to one year in the FAQ, Guiding Principles, SOP #1, #2, and #3. | |
| Q&A documents should be accompanied by a running log of all questions of clarification posed to Health Canada, posted to the same website as the Q&A document. (External) | This is not operationally feasible at this time, due to the sheer volume of clarification questions posed to TPD/BGTD on a daily basis. No change made. | |
| Avoid bottle neck situations where every document requires signatures from two Directors. (Internal) | The signatures of two Directors are not currently required; only the Lead Director is responsible for the issue and approving documents. No change made. | |
| Better define the role of the Bureau of Policy, Science and International Programs (TPD). (Internal) | This is an implementation issue and will be considered by TPD as part of the GGP implementation plan. No change made. | |
| Include a list of Contacts. (Internal) | Chapter 8 - Contacts - is being developed and will form part of the finalized GGP Manual internally. | |
| Add the definition/scope of necessary consultations to the project lead's responsibilities, to avoid conflict between process and content leads. (Internal) | It is the responsibility of the Project Lead (and the Lead Director) to define or scope the consultations that will be necessary for a specific issue. This will be outlined in the Action Plan (and approved by DMC) to avoid future conflict. No change made. | |
| Explicitly indicate that the project lead can be identified from any area in the Directorate. (Internal) | Agreed. The Roles and Responsibilities will be clarified to indicate the Project Lead can be identified from anywhere in the Directorate but that the policy areas must be made aware of developing issues. | |
| Clarify who is an 'affected' bureau/centre/office/directorate, and clarify expectations for internal consultation and when it is sufficient. (I.e. is a full 30-day internal consultation period always required?) (Internal) | The 'affected' area will vary depending on the issue. It is the responsibility of the Project Lead (and Lead Director) to define this, as well as the scope of consultations that will be necessary, for a specific issue. These will be both be outlined in the Action Plan (and approved by DMC) to avoid future conflict. No change made. | |
| Add an introduction to inform staff of GGP and its intended purpose (a Foreword? Or use FAQ?). (Internal) | The Guiding Principles and Frequently Asked Questions were intended as an introduction. No change made. | |
| Frequently Asked Questions: Good Guidance Practices | ||
| B2. | Provide examples of the two types of guidance documents. (External) | The two types of guidance documents are not mentioned elsewhere in the Manual, therefore this question will be removed from the FAQto avoid confusion. |
| Include this terminology in the guidance templates in Chapter 5 to further distinguish between guidances. (External) | ||
| B8. | Give direction as to when the content in the guidance document can be implemented (e.g. during consultation period?). (External) | As described in the Guiding Principles, guidance documents will be published in final form prior to implementation. The accompanying Notice will describe the implementation period, including any transition provisions. No change made. |
| Include average timelines for converting draft guidance documents to final guidance documents. (External) | It was felt that target timelines would be more useful than averages; however, neither TPD nor BGTD are currently resourced to implement targets. This may be considered as a future implementation issue. No change made. | |
| E5. | Keep stakeholders informed of TPD/BGTD's work on an issue (whether 'narrow' or 'complex'). Include additional information in the Public Involvement Calendar, including what issues are being analyzed, which guidance documents are scheduled for review, etc. (External) | The Public Involvement calendar is published regularly and includes issues which will be the subject of upcoming consultations. This is an implementation issue that will be carefully examined so that the processes for issue analysis and guidance development are transparent. No change made. |
| GGP Manual Chapter 1: Guiding Principles | ||
| Shorten the timeline for finalization of a draft guidance document to less than two years; a draft version could be out of date before implementation. (External) | This will be shortened to one year in the Guiding Principles and added to SOP #2. | |
| Review existing guidance documents posted on the HC website to ensure they are finalized. Several existing drafts date back to 2001. (External) | In addition to being examined as part of the needs assessment and prioritization, this is an implementation issue and will be the focus of attention in the coming months. No change made. | |
| 'Periodic review' should be defined with a specified or recommended target date for review (x years after implementation). If the document is reviewed and changes are not necessary, the review date should be added to inform stakeholders it has been reviewed. (External) | Periodic review is defined in SOP #3 and will be shortened to one year (as addressed above). In addition, to inform stakeholders and staff when a document has been reviewed, the Last Updated date on the website (external) and in the Metatag Database (internal) will be changed when the document has been reviewed; SOP #1 and #2 will be revised. | |
| Consult with stakeholders on the relevance and necessity of revisions to existing guidance documents. Post a notice to inform stakeholders of guidance documents coming up for review to solicit feedback and interest. (External) | This is not solely an external decision; whether revisions are necessary and feasible depends on TPD/BGTD priorities and resources in addition to external feedback. In addition, as described in the FAQ, stakeholders may identify subjects for guidance, or guidance documents needing revision. No change made. | |
| IASs are often not accessible or posted on the website. Make available a list of existing documents, or contact information to request this information. (External) | IASs will be available upon request, or posted on the website. This information will be included in the published Notice. No change made. | |
| GGP Manual Chapter 3: Roles & Responsibilities | ||
| Publications Unit/Website Coordinator | Should setting up a standard review cycle for published documents be the responsibility of the Project Lead or Contact instead? (Internal) | Not all issues are cross-cutting, many are very specific to (for example) specific review areas. No change made. |
| GGP Manual Chapter 4: Procedures: SOP #1: Issue Analysis | ||
| General | The process should be streamlined, so that the Lead Director takes responsibility for reviewing the analysis throughout the development, and the number of DMC approvals is limited. (External) | The process is intended to be tailored based on the issue (including whether it is narrow or complex). It is important that DMC be informed about issues ongoing, although it is recognized that DMC processes must be efficient in order to streamline the process. No change made, though this will be reviewed in future iterations of the Manual. |
| 2, Scope | Are there issues that do not include all areas? Wouldn't all issues be cross-cutting? (Internal) | Not all issues are cross-cutting, many are very specific to (for example) specific review areas. No change made. |
| Issues impacting the regulations aren't always complex. (Internal) | This was included to ensure the Regulatory Development Process is followed for these issues. No change made. | |
| 5.1, Step 1 | Revise to better reflect process map re: issue arising at (and lead assigned by) DMC vs. issue arising in review area (and assigned with no DMC involvement). (Internal) | This level of detail was not considered to be necessary for the process map as it is intended to complement, not replace, the SOP text. No change made. |
| 5.1, Step 2 | Health Canada should be aware of what is occurring internationally and adopt best practices wherever possible. This should be an essential part of the process (not just a Question to Consider). (External) | This is part of the process, in Step 2 (it is not just a Question to Consider). No change made. |
| Keep IPD in the loop but do not necessarily hand project over to them, or they will be responsible for 99% of projects. (Internal) | The SOP does not state that IPD/BIO will become the lead; instead, it allows for IPD/BIO taking a more active role or possibly taking the lead, depending on the issue. No change made. | |
| 5.1, Step 3 | Remove reference to Issue Identification Paper as no template is provided. (Internal) | A template for an Issue Identification Paper is provided. Reference to the template will be included in the information following Step 3. |
| 5.1, Step 4 | Add that if a policy analyst is helping with the file, it is not necessary to get Policy Director approval. (Internal) | The SOP does not state that Policy Director approval is necessary. No change made. |
| 5.1, Step 5 | This is the first reference to a 'cross-Directorate issue'. Should it be referenced/explained earlier? (Internal) | A definition of cross-Directorate issue is included in Chapter 2. In addition, this will be referenced earlier, in Step 3. |
| In a cross-Directorate issue, other Directorates should not have the option to choose not to participate. (Internal) | Every DMC has the right and obligation to set its own priorities based on its own issues and resources available. The Questions to Consider indicate the Project Lead should have a contingency plan if different Directorates make different decisions about participation. No change made. | |
| 5.1, Step 8 | A request to publish comments should be made to ensure there are no objections. (SOP #2 as well.) (External) | This is not considered to be necessary as stakeholders will be told upfront (as part of the consultation request) that information may be published unless objections are received. Going to each stakeholder individually is not operationally feasible. No change made. |
| Add that the working group members should inform their Directors when something is ready to move forward. (Internal) | Keeping their Directors informed throughout the process is part of the responsibilities of working group members outlined in Step 6. No change made. | |
| 5.1, Step 10 | Consideration should be given to whether an Early Warning Report is needed for this issue. (Internal) | Agreed. This will be added to the Questions to Consider for Step 10, SOP #1 and Step 6, SOP #2. |
| 5.1, Step 11 | What could 'complete any additional documents needed' include? (Internal) | This may change depending on current operational requirements. Staff should contact the Publications Unit/Website Coordinator to ensure they have the most current information required, and to discuss any questions or concerns. No change made. |
| 5.1, Steps 11 and 13 | Keep the time between steps 11 and 13 as tight as possible, to ensure a smooth transition of knowledge between leads. (External) | Agreed. No change made. |
| 5.1, Step 12 | All relevant IASs should be published in the interests of transparency, and to provide useful background information. The URL should be included in the FAQ. (External) | There is currently no central repository for IASs. While TPD/BGTD agree that IASs should be published when possible, at times this is not operationally feasible and the documents will be made available upon request instead (details will be explained in the Notice). No change made. |
| The IAS should be made available upon request but not routinely published; it should not be our principle consultation vehicle. Translation is extremely expensive and the document may require editing for information that cannot be disclosed. (Internal) | It is recognized that publishing the IASs is not always operationally feasible, and that some editing prior to publication may be required for specific types of information. However, the documents should be made available upon request in the interests of transparency. In addition, the Step is identified as Optional. No change made. | |
| 5.2 | Contacting the Publications Unit/Website Coordinator early does not expedite the process as documents and metatag data are needed before anything can be initiated. (SOP #2 as well.) (Internal) | This phrase will be reworded for clarity. |
| GGP Manual Chapter 4: Procedures: SOP #2: Guidance Development | ||
| 5.1, Step 1 | Have a transfer process in place to allow a timely transition if a new lead is assigned. (External) | Agreed. This will be added to Step 1 of SOP #2. |
| 5.1, Step 2 | Create a mandate for all Terms of Reference, i.e. an overarching process that would apply to all working groups, instead of having to outline the specific roles and responsibilities of each member. (External) | This is outside the scope of GGP. A template and sample have been provided, which is fairly standard; however, changes may be required depending on the issue. No change made. |
| 5.1, Step 3 | Always post a notice to the website if a guidance document from another jurisdiction is adopted by Health Canada in full. (External) | Agreed: it would be posted as a Health Canada guidance document. No change made. |
| The process for adoption is unclear (i.e. is the internal review omitted and the abbreviated comment period used?). (External) | The SOP is clear that a document to be adopted will be considered a Health Canada guidance document and will continue through the process (including internal and external consultation). No change made. | |
| There is relatively little guidance on how to write a guidance document. (Internal) | These instructions are provided in SOP #4 (Completion of the Guidance Document Template) and Chapter 6 (Style Guide). References to these documents will be improved. | |
| There is relatively little guidance on implementation plans. (Internal) | An implementation plan template and several samples are provided. This will be an issue to be addressed as part of the implementation of the GGP Manual. No change made. | |
| 5.1, Steps 6 and 7 | Translate documents prior to presenting to DMC. (Internal) | DMC approval should mean that the documents are ready to be posted (therefore they should be translated prior to presenting to DMC). However, DMC has decided that it is not absolutely necessary for documents to be translated prior to DMC review, therefore there may be exceptions. This will be clarified in SOP #1, #2, and #3. |
| 5.1, Step 7 | Provide timelines for the finalization of a draft guidance when it is posted. There is confusion currently between drafts which are to be implemented immediately vs. drafts published for comment only. (External) | As per the Guiding Principles, guidance documents will be finalized prior to implementation. The Notice that accompanies a draft guidance document should include approximately timelines for the finalization (and implementation) of the guidance document. No change made. |
| Streamline the process. Instead of preparing a document addressing all comments received (available to those who were consulted) and a summary of consultations to be published along with the final guidance document, publish the summary with every guidance document and do not prepare the document containing all comments for those who were consulted. These are available through ATI. (External) | This was not intended to be two separate documents. At a minimum, a document should be made available to those who were consulted; ideally, this will take the form of a summary of comments received, which will be published. The text will be reworded for clarity. |
|
| GGP Manual Chapter 4: SOP #3: Revisions to Published Documents | ||
| General | Having a designated Contact for each published guidance document is extremely beneficial. (External) | Agreed. No change made. |
| 5, Instructions | Have a repository, archive or list of documents removed from the website as they may still be relevant for upcoming submissions. (External) | Currently, maintaining a posted list of archived documents is not operationally feasible. As part of pre-submission consultations, sponsors should discuss requirements for upcoming submissions. No change made. |
| 5.1 | Modify the process to reduce any time-consuming or unnecessary steps. This includes the review by DMC to agree that the proposed changes are administrative. (External) | It is important that DMC be aware of proposed changes, and agree that they are administrative so that they can follow the appropriate process (currently there may be different interpretations of 'administrative' changes). No change made, though this will be reviewed in future iterations of the Manual. |
