Ask an Expert with Leo Schilling – Developing New Veterinary Products (PART 1)
Our Ask an Expert Series showcases Eurofins scientists from around the country and answers questions frequently asked by customers. The questions below are answered by Leo Schilling M.Sc., Senior Scientific Services Manager with Eurofins Animal Health Testing.
What are some key considerations when deciding whether to pursue development of a new animal veterinary product?
When deciding whether to pursue the development of a new animal veterinary product, there are several key considerations to keep in mind. These may include assessing the potential demand for the product, identifying the specific needs or challenges it addresses within the veterinary industry, understanding the competitive landscape, ensuring it is safe and effective for animal use, and identifying any regulatory requirements or challenges that may impact its development and launch. It is also important to consider the financial feasibility of the project and whether it aligns with the overall business strategy and goals.
Are there any specific regulations or guidelines that must be followed when developing veterinary products?
Yes, there are specific regulations and guidelines that must be followed when developing veterinary products. Veterinary medicines must meet the same safety, quality, and efficacy standards as human medicines do, and need to be carefully regulated and approved. Quality pet care is also essential for ensuring the health of your pet and should only be given by experienced veterinary technicians/assistants. To ensure safety and quality, veterinary medicines are subject to several different regulatory frameworks. The Veterinary Medicines Directorate (VMD) of the Department for Environment, Food and Rural Affairs (DEFRA) is responsible for regulating and approving veterinary medicines. Similarly, the Veterinary Medicines Regulations (VMR) specify the criteria that need to be met before a veterinary medicine can be approved and marketed. These regulations include requirements for pre-marketing authorization as well as post-marketing surveillance of all approved medicines. By adhering to these regulations, developers can ensure the safety, quality, and efficacy of their products in order to provide high-quality care to pets.
What regulatory bodies are involved in the development process for animal veterinary products?
Veterinary drugs, vaccines, and other products are regulated by various regulatory bodies in the United States, Canada, and Europe. These organizations oversee the safety, efficacy, and quality of veterinary drugs and other products, and provide guidance and approval for their development and distribution.
These organizations include the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM), the European Medicines Agency (EMA), and the Veterinary Medicines Directorate in the UK. They oversee the safety, efficacy, and quality of veterinary drugs and other products, and provide guidance and approval for their development and distribution.
- The CVM is a division of the United States Department of Agriculture that is responsible for regulating veterinary drugs used in animal food production. It reviews all applications received to sell or market a new animal drug or an animal vaccine in the United States. If a drug is deemed unsafe or if it fails to meet current good manufacturing practices (GMPs), it can restrict its use or withdraw it from the market.
- The EMA is an agency of the European Union that performs safety evaluations on all medicinal products authorized for use in animals by EU member states. It ensures that these products are safe for animals to use under normal circumstances.
- The VMD is a UK government agency that licenses veterinarians to prescribe veterinary medicines in the United Kingdom. It also assesses new veterinary medicines before they can be sold in the UK by ensuring they are both safe for use in animals and effective at treating conditions in livestock.
The CVM, EMA, and VMD are all part of the European Union (EU), which has established a harmonized system for the regulation of veterinary medicines in Europe. The VMD is based in the UK, which also has an established regulatory agency for veterinary medicines, called the Veterinary Medicines Directorate (VMD).
The CVM is located in the United States at the Center for Veterinary Medicine within the U.S. Food and Drug Administration (FDA). This center was founded in 2002 to support the development and review of new drugs for animals. The CVM works closely with other agencies within FDA such as the Center for Biologics Evaluation and Research (CBER) and Center for Veterinary Medicine ensure that all new animal drugs are safe and effective before they are approved by FDA.
The EMA is based in London, UK, and serves as an independent body responsible for regulating veterinary medicines throughout Europe. It was established under European law in 2002 as a consultative body to provide advice on matters related to veterinary medicine to EU authorities. The EMA develops guidelines and decisions on how to regulate veterinary medicines across the European Union and issues opinions on safety concerns regarding certain products.
The VMD is a government agency responsible for ensuring that all veterinary medicines sold in the UK are safe and effective. They conduct clinical trials and reviews of new products to help ensure they are effective, safe, and suitable for use by veterinarians.
Meet the Expert
Leo Schilling
Scientific Services Manager, Eurofins Animal Health Testing
Leo Schilling is a technical expert and innovator engaged in supporting the Animal Health commercial market. He has multidisciplinary experience in analytical chemistry, biotechnology, food and feed quality testing, research & development, and regulatory compliance.
Let's Start the Conversation
Our animal health testing facility provides a full suite of services and solutions customized to meet your individual needs. Regardless of your product type, whether finished feed, premix, mixed ration, or feed ingredient, we have the technology, equipment, and expertise to properly handle and monitor your sample from preparation to analysis.
