What are Veterinary Pharmaceuticals?

Veterinary pharmaceuticals are medicinal products that are used to prevent or treat diseases that occur in animals. These products can be vaccines, anti-inflammatory drugs, antibiotics, anesthetics, etc. all for veterinary use. The animal health sector is facing rapid developments and expansion which highlights the need for stringent regulatory oversight to ensure safe, effective, and high-quality veterinary pharmaceuticals.

What does the global regulatory landscape for veterinary pharmaceuticals look like?

The global regulatory landscape for veterinary pharmaceuticals is relatively complex and differs from that of human pharmaceuticals. This veterinary pharmaceutical regulatory landscape differs depending on the global agency.

• United States: The US FDA regulates veterinary pharmaceuticals under the Federal Food, Drug, and Cosmetic Act wherein the Center for Veterinary Medicine (CVM) oversees the approval and monitoring of veterinary products.
• European Union: The EMA plays an important role in regulatory veterinary pharmaceuticals in the EU. The EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) evaluates all veterinary pharmaceutical applications, ensuring compliance with EU regulations. EMA’s objective for veterinary pharmaceuticals is to harmonize approval processes across Member States, allowing veterinary pharmaceuticals to be marketed in multiple EU countries.
• Canada:Health Canada regulates veterinary pharmaceuticals via the Veterinary Drugs Directorate (VDD), which assesses the safety, efficacy, and quality of veterinary pharmaceuticals before granting approval.
• Singapore: The Agri-Food & Veterinary Authority (AVA) of Singapore, which is part of the Singapore Food Agency (SFA), regulates veterinary pharmaceuticals in the country.
• Australia: The Australian Pesticides and Veterinary Medicines Authority (APVMA) is responsible for regulating veterinary medicines in Australia.

What are some of the challenges associated with veterinary pharmaceuticals?

Despite global regulatory frameworks, veterinary pharmaceuticals as an industry is associated with many challenges. These can be attributed to discrepancies in regulations between countries that may lead to complications in product availability and even international trade.

The veterinary market tends to lack extensive clinical trial data that is usually required for human pharmaceuticals, which can further complicate compliance with approval processes. There is also a growing concern over antimicrobial resistance, which has triggered regulatory agencies to establish stricter regulatory controls on the use of antibiotics as veterinary pharmaceuticals.

DDReg’s Capabilities

DDReg provides comprehensive regulatory services for veterinary pharmaceuticals while ensuring 100% compliance with global regulations and standards. The team provides support in developing regulatory strategies, preparing submissions, and guiding customers to ensure rapid product approvals in global markets including USA, EU, UK, Canada, and other countries. The team has in-depth experience and knowledge of navigating complex regulations as well as managing pharmacovigilance services for veterinary pharmaceuticals.