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 deterrent to investment in product development for the Australian market. Opting to develop and register products overseas, or not at all, has a real downstream effect where Australian Veterinarians, farmers and consumers have fewer economical or innovative agvet chemical options available.
From our perspective, the roots of uncertainty begin with AgVet Code Section 14 which cites the APVMA must register a chemical product if it is satisfied the product meets the safety criteria, the trade criteria and the efficacy criteria. Of course, ‘satisfied’ means different things to different people. It is truly subjective and problematic for the industry. We believe the ambiguity that exists around APVMA satisfaction is the unknown quantity that feeds the lack of certainty for applicants.
We are passionate about turning this around, but to do this, we need continue to develop product concepts to challenge the system and engage the regulator for clarity. For that, we need clients to have confidence in the process. In this series of articles we’ve collated some of our ideas and approach to development and registration. We encourage you to think about your products and how they fit with these ideas. We are very interested to talk to you about the path we can define for your products through the regulatory system.
