- PDF Version (415K) - Print Friendly - Help

AgVetLink: Number 56, June 2006

VICH Update

The 18th VICH Steering Committee (SC) meeting was held from 31 May 2006 to 1 June 2006. Items of interest from the meeting included the following:

• The EU is developing a ‘Monitoring and Maintenance’ guideline for updating existing VICH guidelines.

• The Metabolism and Residue Kinetics working group has agreed priorities and topics. The group is to develop guidelines over 27 months with two face-to-face meetings and electronic meetings as needed. Acute reference dose calculations for injection site residues are not to be part of their remit in the first phase.

• The Quality working group was given approval for one more face-to-face meeting, subject to further clarification of reasons for the meeting and identification of issues to be finalised.

• The Pharmacovigilance working group (Guideline [GL] 35 list of terms) was authorised to hold one more face-to-face meeting to finalise ‘list of terms’. This meeting is to take place prior to the next VICH SC meeting.

• Standard Language (GL 29) was signed off at Step 6.

• Electronic Standards for Transfer of Data (GL 35) was deferred to wait the outcome of the ICH meeting on the same issue.

• The Biologicals Quality Monitoring working group was directed to put activities on hold until the working group has had the opportunity to revisit guideline content in relation to the newly available mycoplasma reference strains. This issue will be on the next SC meeting’s agenda. (The possibility of Australia/New Zealand laboratories taking reference strains is being discussed.)

• Pharmacovigilance Control list of terms (GL30) progressed to Step 4 for public comment.

• Target Animal Safety for Pharmaceuticals (GL43) is to be released at Step 4 for public comment.

• Pharmacovigilance on Management of Periodic Summary Updates (PSUs) (GL 29) was adopted at Step 7 for regional update by regulators.