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 guidance material relating to application types, filling a void that currently exists for applicants. The guidance material will include examples to assist applicants in their decision making and module selection. The initial focus will be on creating guidance material for about five significant application types incorporating variations, generic pathways and new products based on existing actives. The APVMA are working up some of the material now and we would expect to be given an opportunity to review the fruits of their labour in the not too distant future.
This approach may sound familiar to many who have been around a while. I get the feeling that sometimes you have to go backwards to go forwards. It is reminiscent of the discarded Memorandum of Rules and Guidelines (MORAG) which preceded the web based guidance material. It was a reasonably useful document in its day. Nevertheless, the concept of having relevant examples in the guidance material is great. I reason that if industry and regulator are working from the same manual, that would hopefully mean we are on the same page, surely a good start.
If I could add a suggestion we must keep the APVMA focused on guidance material that always allows the industry to manage the regulatory burden to be adequate to address regulatory risk. Any guidance material we develop in partnership with the APVMA should provide greater insight into the APVMA’s perception of risk for the individual product, function or claim. Certainly, if the APVMA were to share their risk assessment methodology incorporated in examples within the guidance, it would lead to greater understanding of the risk they associate with each product. Understanding the risk allows developers to select appropriate studies and generate data, information or argument that is on-target to support the application. Module descriptions don’t give that level of detail, and can yield an application with a complete disparity between available information and perceived risk.
With the regulator now at a cross-road, the Top 20 project presents an opportunity for this industry to develop some practical guidance material. With the relocation effort firmly underway, this project sits within the overall strategy where the APVMA must address the fact that their historical regulatory knowledge base will be depleted as experienced staff look for opportunities outside of the APVMA. Industry offers a stable, motivated pool of regulatory expertise, so engaging this group to develop and refine guidance tools is a positive move. If given the chance, the result of this project should be the model the APVMA take forward and absorb into their culture as they engage the industry as a reformed regulator.
However this Top 20 evolves, we need technical people from our industries in there to focus on priority items, to understand and define the risk that may apply to various product types, but more importantly, influence the APVMA’s risk appetite.