Proposal to Waive Target Animal Batch Safety Test for Veterinary Vaccines

The APVMA expects applications for registration of veterinary vaccines to comply with standards set out in the current European Pharmacopoeia (Ph. Eur.) or Title 9 of the Code of Federal Register, where relevant monographs exist.

To ensure consistency between the Ph. Eur. and APVMA requirements, and in the interest of animal welfare (the '3Rs' principle – reducing, refining, and replacing the use of animals in tests), the APVMA proposes to remove the requirement for Target Animal Batch Safety Testing (TABST) for registered veterinary vaccines.

The proposed TABST waiver only applies to finished product control testing of registered veterinary vaccines. The requirement for safety testing prior to registration will not change.

Why the change?

In April 2012, the 142 Session of the Ph. Eur. Commission agreed to delete TABST from the Ph. Eur. for all veterinary vaccines.

Improvements in the manufacturing process of veterinary vaccines in recent decades, coupled with the introduction of new requirements regarding in-process testing and controls on starting materials have reduced the need for target animal testing for routine batch release. Deletion of the requirement for TABST reduces the need for animal testing without significantly increasing risks.

Exceptions

There are, however, three exceptions to this general rule:

• Porcine actinobacillosis vaccine (inactivated) and Porcine progressive atrophic rhinitis vaccine (inactivated). TABST with 2 doses of vaccines (former Section 3-3. Safety) was retained for these vaccines because there was an inherent batch-dependent safety risk. The name of the test was changed to 'Residual Toxicity Test' to avoid any misunderstanding. Neither vaccine is registered in Australia.
• Tetanus vaccine for veterinary use (0697). The safety test (former Section 3-3) performed in guinea pigs has been renamed to 'Residual Toxicity Test' to avoid any misunderstanding. The test itself has not changed. This test will still be required for tetanus vaccines registered by the APVMA.

The Ph. Eur. general monograph Vaccines for veterinary use (04/2013:0062) allows for further safety testing to continue on an ad-hoc basis, by agreement or at the request of the competent authority. in 'particular circumstances'. These particular circumstances include significant changes to the manufacturing process, reports of unexpected adverse reactions, or reports that the final batches do not comply with the data provided during registration.

Comments are invited

We invite comments from industry and the general public on the proposed deletion of Target Animal Batch Safety Testing for veterinary vaccines, with the above-mentioned exceptions, and comments on circumstances under which further safety testing may be required.

Following receipt and consideration of comments, the APVMA will decide whether to make the change and will inform registrants.

Submissions must be received by the APVMA by 9 September 2014 and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing by email or post.

When making a submission please include a:

• contact name
• company or Group name (if relevant)
• email or postal address
• the date you made the submission.

Submissions should be addressed to:

Senior Evaluator
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604

Email: enquiries@apvma.gov.au
Fax: +61 2 6210 4741

For enquiries, please call +61 2 6210 4884