APVMA meets with industry

The Australian Pesticides and Veterinary Medicines Authority (APVMA) held a seminar in Canberra at the end of March discussing, amongst other things, revisions to the Efficacy Guideline.

One of the topics of interest was labelling, including the some comments about the unnecessary technicality of terms used on labels and the need for simpler procedures for the approval of minor label changes such as colour changes. The APVMA agreed to take these concerns on board and refer label content issues to the labelling reform working group.

There were also questions about the extended period required for approving marketed product labels (MPLs) compared with the previously approved text labels, with the APMVA saying that the quality of labels had improved markedly since the implementation of MPLs and that it expected the full implementation of E-labels should improve turn-round time.

The APVMA invited nomination of representatives from the pool industry to join the labelling reform group.

The afternoon was taken up with discussion on the revisions to the Efficacy Guideline. Dave Loschke began proceedings by explaining the background to the Guideline, including the need for efficacy standards and the use of chlorine as the reference standard, as in the US, Canada, the EU and the UK.

There followed a series of discussions about a variety of areas to do with the Efficacy Guideline, including testing methods, equivalence, the inclusion of various organisms and the exclusion of others. While the need for peer reviewed benchmark tests and methods was supported, the need for both laboratory and field testing was queried by some, but defended by Loschke, who said it would be irresponsible to put humans in a pool without doing the preliminary studies. There was also a general discussion of submissions and data generally, and the need for trials to cover periods of high challenge.

Loschke said the issues will be taken on board and an amended Guideline version will be available within 2 months. 

The seminar seemed to be successful and the APVMA agreed to have more of these seminars with users as well as registrants.