Without question, at a time when the Government emphasis is on ‘red tape reduction’, the AgVet industry is operating in a period of unprecedented regulatory burden. Pia Pharma is committed to staying on top of the issues affecting chemical product regulation in this sector and making the system work. We’ve recently attended the APVMA update session in Melbourne and various Industry group meetings on critical topics such as the regulatory issues arising from the APVMA interpretation of legislation about use of Confidential Commercial Information (CCI), increasing registration data requirements, global harmonisation of labels, active constituent approvals and reporting requirements.
We’re taking the insight we’ve gained and using it to implement effective science-based strategies to address regulatory requirements. With this approach we are achieving positive regulatory outcomes that are leading to commercialised AgVet products.
With the recent Federal Court ruling regarding the APVMA interpretation of the legislation about the use of Confidential Commercial Information (CCI), the industry now contemplates life without CCI. Logically, removing the restrictions imposed by CCI should increase the predictability of a positive regulatory outcome for organisations involved in development of generic and innovative products alike. We’re staying on top of developments in this regard but not losing sight that we still have to work within an evidence based, first-world regulatory system. Our strategies continue to remain focused on applying the right level of science to meet the Statutory Criteria that apply to the appropriate risk model for the chemical product. If you are embarking on AgVet development, or in a situation where you need guidance, don’t hesitate to talk to us.
