NHMRC standards and procedures for externally developed guidelines (2007) were developed to inform external groups developing guidelines which were intended for submission to NHMRC for approval. This document only applies to external groups developing guidelines which commenced development prior to 1 January 2011.
NHMRC procedures and requirements to meet the 2011 NHMRC standard for clinical practice guidelines (the 2011 NHMRC Standard) applies to all guidelines seeking NHMRC approval which have commenced development after 1 January 2011.
Key changes to the process which are effective immediately and apply to all guidelines seeking approval are:
- The NHMRC Guidelines Assessment Register (GAR) program has ceased. Guideline developers are now responsible for accessing methodological expertise.
- Developers are required to submit a progress report to NHMRC 3-6 months prior to public consultation. A template for the progress report can be found here.
- Developers will be asked to nominate up to 6 potential reviewers who are clinical experts in area/s covered by the guideline and are independent of the guideline development process. NHMRC will engage independent clinical expert reviewers as part of the approval process. Further details on the nomination of these reviewers is provided here.
- Developers are now required to circulate the public consultation draft to relevant government agencies, including the Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC) and Medical Services Advisory Committee (MSAC), and to the Director-General or Executive Officer of each Australian health department (state, territory and Commonwealth) as part of the public consultation process. All responses (including ‘nil response’) should be captured in the summary of public consultation submissions.
- As part of the public consultation process, NHMRC will notify NHMRC Council Members that the public consultation draft is available for their comment as individuals or on behalf of their jurisdictions.
- Developers are required to submit their guideline to NHMRC 2 months prior to a scheduled meeting of NHMRC Council. This allows NHMRC time to seek independent methodological and clinical expert review and request further information from developers
- NHMRC approval is no longer provided for companion documents, although developers are encouraged to continue to develop companion documents to facilitate the dissemination and implementation of the guideline content to relevant end users.