Key regulatory considerations for veterinary vaccine development in the EU and the US

Developing and registering a veterinary vaccine for the global market can be challenging. A product registration in the European Union (EU) and/or the United States of America (US) is considered by many in the animal health industry as the key to unlocking other global markets. There are some important differences in the regulatory requirements for licensing veterinary vaccines in the EU and US, and this will be the focus of this article. However, with extensive up-front planning, it is possible to minimise the additional cost and time required to satisfy the requirements for both of these major markets. The key regulatory issues that should be considered when planning a development plan for the EU and US are discussed.