Section 8S(1)(a) – Notice of proposal to refuse application

After an agonising wait during an evaluation, you receive communication from the APVMA that one or more aspects of your application has not met the criteria for the APVMA to support registration.  The wording can be intimidating, and generally if you do not wish to accept their option, the APVMA are required to issue an 8S notice, proposing to refuse […]

APVMA Top 20 Project – stepping in the right direction

The APVMA’s Top 20 project is looking at feasibility of developing tailored guidance material for common application types. In March Pia Pharma participated in the first Top 20 workshop along with fellow members of the VMDA, members of AMA, Accord and Crop Life.  A key outcome of the project is intended to be delivery of […]

The science of satisfaction

The APVMA registration process is evidence based, and APVMA satisfaction is reliant on provision of information to address statutory criteria to support the intended product, use or claim. Generating information requires an investment (time, money, emotion), and those in commercial operations realise there are limits to all of these. The objective is to generate information […]

APVMA registration – a lack of certainty is stifling development

Pia Pharma’s core businesses is the provision of high quality analytical and regulatory services, and delivering commercial outcomes for clients involved in agricultural and veterinary chemical product development. Our clients in generic and innovative development space frequently cite a lack of certainty of a favourable outcome from the APVMA regulatory review process as a major […]