Streamlining registration for new poultry vaccines

A workshop to help researchers navigate the registration processes for vaccines and other poultry health products has been held by Bioproperties Pty Ltd, an SME manufacturing animal vaccines in Australia.

Before new vaccines for layers or meat chickens are released, they need to pass through the stringent demands of the Australian Pesticides and Veterinary Medicines Authority (APVMA), the Office of the Gene Technology Regulator (OGTR) and, in some cases, the European Union (EU).

"The workshop was for those researchers who have not undertaken registration studies or who may need a refresher," said Dr Rima Youil, R & D Manager at Bioproperties.

"It's important to 'do the right thing' from the start so that registration studies are completed on time and to avoid any repetition of work if it’s not done to the standard stipulated by the regulatory authorities."

The registration workshop was directed at the stage when the vaccine project has reached 'proof-of-concept' and aimed to provide researchers with:

* an overview of the registration process;
* the ability to assess the market potential of the vaccine;
* the steps to take before registration and how to plan the process;
* the know-how to create and scale up a master seed;
* an understanding of the product specifications;
* knowledge of how to go about the registration studies; and
* an introduction to registration processes (APVMA, OGTR and EU).

The one-day workshop, organised with the help of the Poultry CRC, was run at Bioproperties' Glenorie manufacturing facilities. Those involved included researchers from The University of Melbourne, the Department of Primary Industries and Fisheries (Queensland), RMIT University and CSIRO.