Abstract
Animal healthcare is a booming market catering needs of several companion and production purpose animals. Animal drug approval process in the United States (US) involves submission of an Investigational New Animal Drug Application (INAD), followed by submission of New Animal Drug Application (NADA) to the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM). Although regional variations are present in the regulatory process for veterinary healthcare products across the globe, harmonization initiatives like International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) are playing a vital role in the veterinary medicinal product registration process by availing detailed guidance documents. The current article focuses on the regulatory requirements for new animal drug registration in the US.
Highlights
Over the past two decades, global animal healthcare market has captured attention of top global pharmaceutical companies
According to Vetnosis, a leading research and consulting firm specializing in global animal health market, shares of animal healthcare sector are primarily distributed in the West where, 47% of the market is based in the United States (US), 32% in the Europe and 21% in the rest of the world (Figure I) [2]
Upon conducting market assessment for unmet animal needs, availability of business opportunities and completion of preliminary screening of new drug in the discovery and development stage, if the biopharmaceutical company decides to go for more expensive registration phase, the company needs to submit a letter to the ONADE of Center for Veterinary Medicine (CVM) to open an Investigational New Animal Drug Application (INAD) file and to initiate the drug registration process
Summary
Over the past two decades, global animal healthcare market has captured attention of top global pharmaceutical companies. Regulatory agencies for animal health products approval in the US include the US Food and Drug Administration’s (US FDA) Center for Veterinary Medicine (CVM), the US Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) and the Environment Protection Agency (EPA). Irrespective of variations in regulatory framework across regions, the basic rule of animal drug development includes scientific assessment of animal drug followed by its registration and upon receipt of approval from relevant regulatory bodies, marketing of the product.
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