Health Canada, the Australian Pesticides and Veterinary Medicines Authority (APVMA) and the New Zealand Ministry for Primary Industries (NZMPI) complete first trilateral joint review of veterinary drug product.
On April 28, 2016, Health Canada, the Australian Pesticides and Veterinary Medicines Authority (APVMA) and the New Zealand Ministry for Primary Industries (NZMPI) simultaneously approved a new use for pain relief in sheep for the veterinary drug Metacam. The applicant for this product was Boehringer Ingelheim. Castration of male sheep is a common management practice in the sheep industry that can cause pain and stress to the animal. Up to this point, there has been no product specifically approved to reduce the pain associated with this or other common procedures in sheep.
This approval comes as a result of the first ever trilateral joint review of a veterinary drug submission. Efficacy, target animal safety and human food safety were all jointly reviewed by the three regulatory bodies. It has demonstrated that numerous benefits and efficiencies can be realised by collaboration between countries such as better understanding of each country’s regulatory system and efficient use of resources in each country.
The benefits of this simultaneous approval extend beyond regulatory benefits. Simultaneous access to a new approval for an animal drug in three major markets will lead to improved animal health and food safety. For all participating countries, this approval means farmers will have timely access to a new non-steroidal anti-inflammatory drug for sheep, a minor species, which will enable them to better manage their flocks.
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