Regulatory News


APVMA Assessment Performance

The serious impact of the relocation of the APVMA from Canberra to Armidale continues to be highlighted across the agricultural chemical and veterinary medicine industry sectors.

A Senate’s Standing Committee has tabled its report into the APVMA relocation calling for the order to be revoked and the move to be paused. Crop Life and Animal Medicines Australia both highlight the dramatic decline in the assessment performance by the APVMA with more and more product applications not being approved within the statutory timeframes. The relocation of the APVMA has triggered a large number of staff resignations which is obviously a major factor in the Government Agency not being able to achieve statutory timeframes. The last quarter's assessment performance has been described as the 'worst APVMA performance in history'.

Within the agricultural and animal health sectors there is a big concern that these significant delays deny farmers access to a range of products for a season or longer and will result in significant cost to all industry sectors.   

De Groot Technical Services is experiencing first-hand the impact of the APVMA assessment performance decline, with significant delays now the norm. Given the loss of staff and the challenges of re-establishing in a new location with new staff, it is inevitable that the delays will continue for some time. The concern of course is that the APVMA because of limited resources will find it increasingly difficult to meet statutory assessment timeframes in the medium term future. 

Thus applicantants seeking a timely product registration need to factor in these delays when considering product development programmes.

Time - is nearly always critical in any market entry strategy with a new product.

The most effective way to minimise any negative impact on timeliness is to embark on a robust but disciplined project management and submission preparation process. It's having a clear understanding of the data requirements for lodging a regulatory submission, and then generating data over a range of conditions that allows robust use recommendations to be defined.

At De Groot Technical Services we believe that the combination of disciplined project management and the resources of a highly qualified and experienced team gives our team the edge in getting it right first time.



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