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Inside the Spray Tank: Seeking Advice

October 2009

Welcome back to Inside the Spray Tank – an insider’s view of ACVM operations.

This is the continuation of a series of blogs by Andrew Pearson, who is currently our MRL advisor but also has experience with most of the application types we receive. (photo: Andrew Pearson)

We want applicants to understand the rationale we use to provide a consistent, fair regulatory process. This document looks at one aspect of this process -- our modus operandi when it comes to answering your questions about the amount and type of data for registration applications. The main point I hope to get across is that our advice can only relate to the information requirements and interpretation of procedures.

Questions outside our role as regulator

We regularly get asked questions such as the following:

• If I undertake this number of residue trials will that be enough?

• I have the results from this efficacy study and this argument on safety -- what else do I need to gain registration?

These are the types of questions we just can’t answer. Frankly, the only answer you are likely to get is a link to the information requirements on the web. At best you will be advised to make an information waiver application if you’ve indicated that you are not able to meet one of the requirements.

Why we can’t provide these answers

This may be frustrating if you’re trying to put together an application, but there are several good reasons why we can’t give you an answer:

1. None of the ACVM technical appraisers or operations advisors are registration consultants. We are not employed to provide guidance on putting together an application for regulatory appraisal. However, contact details for the third parties who have expressed interest in being listed as registration consultants are available on our website.

2. By providing direct guidance on getting an application through the registration process we are offering a competitive advantage to one applicant over the rest. Instead, all of the guidance documents we put out (including this document) are published on the public website where they are freely available for any party to read.

3. If we provide a commitment on what is required to meet regulatory requirements and then subsequently the study results do not show the desired result, it leaves us liable for providing incorrect advice. We absolutely will not commit ourselves to accepting a certain number of trials before they are conducted or to providing any type of approval to a study methodology (with the exception of the statutory requirements for using an experimental product, ie provisional registration and research approval).

4. By providing the advice on how to package an application to get through the system we are eroding our status as a regulator as we are exerting influence over the production and assessment of applications. This could lead to a situation where bias could be exerted on applications. For similar reasons, this is why we do not allow consultants or registrants involved in putting an application dossier together to act as data assessors for that application -- it removes the impartiality from the consideration of the data.

Where to get answers

So this begs the question of how you go about resolving some of the questions that we are not in a position to answer.

• As mentioned above, a number of consultants are available to provide guidance through the registration process.

• It’s also worth searching our website for any guidance documents regarding the questions you might have -- we’re currently reviewing the questions we get asked over and over and are putting together FAQs for the website. (Your suggestions for topics are welcome.)

• Finally, understanding the rationale for having certain requirements in place can aid putting together study protocols or waiver arguments. For example, for trials the required number is what is considered sufficient to give an acceptable level of confidence in the results. If the data you generate can demonstrate this confidence clearly with less trials or there is already sufficient understanding of the behaviour of the compound, then undertaking fewer trials may be appropriate. This, however, is a commercial decision and we cannot advise you prior to you commencing a study that your protocol is appropriate.