The UK’s Veterinary Medicines Directorate (VMD) and the Australian Pesticides and Veterinary Medicines Authority (APVMA) have published guidance for the simultaneous review of veterinary medicines submissions.
The regulators will continue to make sovereign decisions in accordance with the relevant national legislation in each country, and both will target a final decision within 210 calendar days of submission acceptance. The arrangement allows for the two regulators to exchange knowledge and expertise between the jurisdictions.
Submissions for minor uses/minor species (MUMS) medicines have been especially encouraged.
The guidance will enable veterinary medicines manufacturers to co-launch their products in both territories and should improve access to veterinary medicines and an expanded the number of treatment options available.
“This exciting new approach can reduce the [administrative] burden and provides the opportunity for a single project team to work on the application, in line with common assessment timeframes,” said Dr Melissa McEwan, APVMA’s Acting Chief Executive Officer.
