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MICROBIOLOGICAL ADI

MICROBIOLOGICAL ADI. Chairperson name: Hayd é e Fernandez Rapporteur name: Peter Silley 13 attendees. VICH GL 36 has been implemented in all regions participating in VICH After ±4 years of experience Different approaches to address the guideline

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MICROBIOLOGICAL ADI

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  1. MICROBIOLOGICAL ADI Chairperson name: Haydée Fernandez Rapporteur name: Peter Silley 13 attendees

  2. VICH GL 36 has been implemented in all regions participating in VICH After ±4 years of experience Different approaches to address the guideline The process has been a continuous learning experience for everybody Regulatory bodies have questions on the ways to address the issue of the fraction of drug available to the colonic flora and on the protocols used. There have been differences in interpretation of the guidance in different regions History

  3. FDA hosted a meeting in April 2008 with international regulators and scientists to share experiences gained while working with this guideline general conclusion was that VICH GL 36 would benefit from the revision of certain sections for clarity and additional guidance Background to the revision

  4. Background to the revision In their February 2009 meeting, SC approved the revision of Section 2.4.1.1. of GL 36, “Fraction of an oral dose available to microorganisms” New EWG: “Microbiological ADI EWG” formed consisting of some of the original Task Force members and additional members Meeting held in Washington, November 2009 Ongoing work, teleconferencing & electronically Final Meeting scheduled in Japan, January 2011 to conclude the work

  5. Main scientific issues Considered that the provision of guidance on the methodology and appropriate interpretation of data aimed at defining the fraction of an oral dose available to microorganisms would represent a valuable step towards ensuring a harmonized understanding of the relevant part of the guideline

  6. Workshop Discussion Will the EWG be able to recommend specific methodologies to determine the fraction available? that is the intention Emphasised that the fraction available is a technical correction to help calculate the microbiological ADI it is NOT a consumer safety issue Experience within the workshop was that there has not been an occasion when a microbiological ADI has been set on the basis of the resistance endpoint and it was questioned whether this endpoint was still considered relevant

  7. Workshop Discussion If new public health concerns were identified arising from the impact of antimicrobial residues on GI tract flora, how would these be addressed Explained that the proper course of action would be for interested parties to prepare a concept paper and submit to VICH steering committee for consideration

  8. Utility and impact of GLs JECFA now uses VICH GL 36

  9. None raised Proposals for new topics

  10. Work is progressing and the EWG fully expect to complete their mandate at the final January meeting in January 2011 Conclusions

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