EUCAST encourages pharmaceutical companies to be prepared to give a first presentation of the agent to the EUCAST Steering Committee before the Centralised Procedure commences. In order to initiate this process, the EUCAST Chairman and Scientific Secretary should be contacted through the official EUCAST website (http://www.eucast.org).
The EUCAST Scientific Secretary will provide the contact details of the current Steering Committee members if this is needed for confidentiality agreements. Prior to the meeting the company should inform the EUCAST Scientific Secretary of the names and roles of the persons who will represent the company at the meeting.
The total time for the first meeting will be 60 minutes. A 30 minute presentation allows time for comment and discussion. The process is most productive if the presenter allows EUCAST members to ask questions and make comments during the presentation. Ideally, the first presentation should contain:
• Brief structure, mode of action, resistance mechanisms/selection of resistance
• Clinical indications and expected benefits over existing agents
• Microbiological activity (full species-related MIC distributions, not MIC50/90).
- submit MIC-distributions using the available MIC templates
- submit zone diameter distributions using available Zone templates
• Administration forms and dosages
• Pharmacokinetic data in healthy volunteers and patients
• Activity in animal models
• Pharmacodynamic studies, Monte Carlo simulations
• Clinical studies
• Relationships between dose, MICs and clinical and microbiological outcomes
• Company proposal for breakpoints
• Planned timescale for studies, regulatory approval
• Anything else that the company considers important/useful
It is very helpful if a copy of the presentation can be sent to EUCAST at least a week before the meeting. The company does not need to produce a "Company Rationale Document" at this early stage but companies have found it useful to bring their data together in this format before the formal process through EMA. No "dossier" is needed but if the company wishes to provide additional information it may do so.
EUCAST will not propose breakpoints at this stage.
EUCAST Rationale Documents list data (dosing, indications, target micro-organisms, MIC distributions, existing breakpoints, pharmacokinetics, pharmacodynamics, clinical evaluation) used by EUCAST in the breakpoint setting process. We suggest that companies prepare a document in the style of the "EUCAST rationale document" (download template) and submit it to EUCAST as early as possible in the process (preferably before or at the latest when filing with EMA). The "Company Rationale Document" will be one of many of EUCAST´s sources of information in the breakpoint setting process. It will be treated with the same confidentiality as all other material which is part of the process. It will be available only to the Company, EUCAST and the Rapporteur. However, the existence of a Company Rationale Document will help highlight differences between the Company and EUCAST with respect to data and interpretation. The Company Rationale Document can be amended by the Company at any time during the process whereby the changed (added or deleted) section must be highlighted and a copy sent to EUCAST and the Rapporteur. A template rationale document and an example of a EUCAST rationale document can be downloaded.
Document updated 2010-06-21