North American Animal Health Regulations (2 Volumes)

Volume I

In the United States, there are three agencies that regulate animal health products. The US Department of Agriculture regulates animal biological products, the US Environmental Protection Agency regulates pesticide products used on animals, and the Food and Drug Administration (FDA) regulates products considered to be animal drugs. It is important to understand this and to realise that for a non-drug product, a different agency in the US may have jurisdiction and, consequently, approval power.

This report comes in two volumes. The first (current) volume takes a detailed look at the legislative and regulatory framework in place. These include the main acts and the FDA regulations. The FDA guidance on getting product approval is also outlined. Practical tips on how to access useful information on the regulatory side are given.

This volume will help you understand how to bring an animal drug product to market in the US. The interactions needed to gain approval for an animal drug, the responsibilities a sponsor has post approval, and how the dossier can be modified to account for needed or desired changes following the initial application will all be explained. This volume also looks closely at getting an approval for generic products in the US.

Also included is the process at the Center for Veterinary Medicine (CVM) for supplemental applications to change or modify the original approved application is described.

Volume II

In the United States, there are three agencies that regulate animal health products. The US Department of Agriculture regulates animal biological products, the US Environmental Protection Agency regulates pesticide products used on animals, and the Food and Drug Administration (FDA) regulates products considered to be animal drugs. It is important to understand this and to realise that for a non-drug product, a different agency in the US may have jurisdiction and, consequently, approval power.

This report has two volumes. Volume I looks at the legislative framework in place governing the acquisition of a market approval for a veterinary drug. This tome (Volume II) concentrates on the practical side of submitting an application for a market authorisation.

The approval process is examined from the standpoint of a sponsor starting with a new chemical entity that is believed to have utility for an animal health need. This begins with the identification of a new compound and the development phase. The ensuing description focuses on a linear progression through the regulatory process in achieving approval to market the product in the US.

The current volume explains what the Background Package is and its role in the pre-approval phase. The Background Package details for the Center for Veterinary Medicine reviewers what the sponsor knows about the molecule (chemical data). This includes literature that may exist, the potential claims the sponsor hopes to achieve, a preliminary outline of a plan of development, and even a draft label that the sponsor hopes to obtain. The explanation then moves on to the presubmission conference, where the CVM meets with the sponsor to discuss a development programme.

This part of the two-volume report guides you carefully through the intricacies of the pre-approval process, as well as the main application and any post-approval requirements.