EMA Publish Concept Paper on Addendum to Guidance on Evaluation of Treatments for Bacterial Infections
This Concept Paper proposes the development of an addendum to the Note for Guidance on Evaluation of New Anti-bacterial Medicinal Products (CPMP/EWP/558/95 Rev 2).
During the revision of the previous version of the guideline (CPMP/EWP/558/95 Rev 1) consideration was given to the need to develop guidance on clinical data requirements to support the approval of specific indications for use. During the consultation period several requests were made for the CHMP to provide more detailed guidance on issues such as patient selection criteria and primary endpoints, including efficacy variables and the timing of the assessment of outcomes. It was proposed that CHMP should give further consideration to, and provide additional clarification regarding, indications for which superiority or non-inferiority study designs could be accepted. In the case of superiority studies, it was requested that further consideration should be given to the feasibility of conducting comparisons between test agents and either placebo or active comparators. In the case of non-inferiority studies there were requests for further consideration of appropriate values of delta. More guidance was considered to be needed regarding clinical development programmes for new antibacterial agents with potential for clinical activity against rare and/or multidrug-resistant pathogens and the accumulation of data to support indications for which there is currently no established regulatory pathway.
In order to gain further insight into the issues raised during consultation a 2-day Workshop was held in February 2011 at which representatives from the pharmaceutical industry and academia met with EU Regulators to discuss several of these matters (insert link to final published report). Taking into account the written comments received during the consultation period and the discussions during this Workshop it appeared to be appropriate to provide additional guidance along the lines requested. It is proposed that following adoption of the revision of the main guidance document an addendum should be developed to provide indication-specific guidance. The issues that have been identified for inclusionor further consideration in the addendum are detailed below.
The content of CPMP/EWP/558/95 Rev 2 covers the general approach to the development of antibacterial agents. This guideline (as with its predecessors) does not provide detailed indicationspecific guidance. It is now apparent that such guidance is needed in order to describe and clarify the CHMP’s position on various matters.
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