Draft Guidance Document: <Name of guidance document>
Summarised Comments and Recommendations from <Internal/External> Consultations

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Template Date August 2007

The draft guidance document entitled <name of guidance document> was generated by <name of working group/ committee/ organization as applicable>. <Insert mandate of working group if applicable>

<Insert details about distribution i.e. distributed internally to all TPD/BGTD staff on <date>; or, published on the TPD/BGTD websites for a 60 day consultation period on <date>, etc. Also indicate if any discussion sessions, presentations, etc. were conducted to solicit comments on the document.> The following is a summary of the 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.

<For external consultation results, the following may be included:>
<Number> sets of comments were received, as follows: <for example>
<Number> multinational innovator pharmaceutical companies (insert attribution numbers),
<Number> device companies (insert attribution numbers),
<Number> multinational industry associations (insert attribution numbers),
<Number> independent pharmaceutical consultants (insert attribution numbers),
<Number> foreign regulatory authorities (insert attribution numbers),
<Number> healthcare professionals (insert attribution numbers), etc.

Section	Line Number(s)	Comment Received	HC Discussion and Recommendation
General comments
		Insert comment followed by (attribution number(s)) or indicate 'No comment received.'
1.1 Policy Objectives
1.2 Policy Statements
1.3 Scope and Application
1.4 Background
2.1 Roles and Responsibilities
2.2
3. Effective Date
Appendix 1: