Enhancing Animal Health Compliance with Comprehensive Medical Information (MI) and Pharmacovigilance (PV) Services

Comprehensive Animal Health Medical Information (MI) and Pharmacovigilance (PV) support services in the veterinary industry are a must-have for companies who want to ensure the safety, efficacy, and quality of their animal health products. Whether it’s pharmaceuticals, vaccines, or other veterinary products, companies must navigate complex regulations to bring their products to market and keep them there.

Regulatory compliance in the veterinary industry is crucial for ensuring the safety and effectiveness of veterinary medicines for animal use. The use of these medicines in food-producing animals also has implications for human health, as regulatory compliance helps protect public health. Failure to comply with legal requirements can result in severe consequences, such as product recalls, fines, and imprisonment. MI and PV services work together to enhance the safety and efficacy of veterinary products, build trust among consumers and stakeholders, and ultimately contribute to better health outcomes for both animals and humans.

Understanding Regulatory Requirements in Veterinary Medicine

Most countries have regulatory authorities overseeing veterinary medicine, products, and animal health. Some of these authorities include:

• US Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM): Regulates the manufacture and distribution of drugs, devices, food, and imports/exports that will be given to animals. Monitors product safety including recalls, adverse events, and drug shortages.
• European Medicines Agency (EMA) Committee for Veterinary Medicinal Products (CVMP): Evaluates medicines for veterinary use in the European Union, monitors the safety of the medicines on the market, and recommends changes in marketing authorization, including suspension and withdrawal from the market.
• US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS): Oversees animal health and welfare such as disease prevention and eradication and emergency management response systems. Monitors the safety and effectiveness of veterinary products and regulates livestock production, trading, and disposal.

Veterinary companies face several challenges in maintaining compliance across different regulatory bodies due to the complexity and variability of regulations worldwide. Each country has its own set of regulations, which makes it challenging for companies to ensure global compliance. Some countries have multiple authorities to comply with; for example, the US has 3 major governmental bodies to comply with regulations along with several well-established private organizations. Regulations also differ by categories such as veterinary medicine, supplements, devices, food, agricultural products, etc. This requires significant resources and expertise to navigate effectively.

Animal Health Medical Information Services

Animal Health MI services are aimed at providing accurate and comprehensive information to veterinarians, pet owners, and other stakeholders, enabling them to make well-informed decisions about animal care. MI services also include internal processes such as medical writing to create and maintain a library of critical documentation.

Animal health MI services may include

• Global 24/7/365 contact center support – Covers every time zone, including holidays, so that customers can reach out for assistance and receive support from a dedicated team
• Adverse Event (AE) intake and follow-up services – Collection, documentation, management, and follow-up of reports related to adverse events associated with medical or animal health products
• Product Complaint (PC) intake and follow-up services – Collection, documentation, management, and follow-up of reports related to product complaints associated with medical or animal health products
• Medical Information (MI) inquiry fulfillment and escalation – Provision of responses to incoming medical inquiries and escalation of complex inquiries to specialized personnel for in-depth response
• Accidental exposure triage with toxicology assessment and follow-up services – Assessment of accidental exposure to animal health, medical, or agricultural products to manage and monitor for patient safety
• Crisis detection and client emergency bullhorn actions – Proactive and reactive approaches to identify potential crises and take immediate, broad-reaching actions to manage and communicate during emergencies
• Medical writing and content management – Creation, organization, and maintenance of response documents and materials

Animal Health Pharmacovigilance Services

Veterinary organizations also need to ensure the safety monitoring of their veterinary products. They are required to track adverse events and ensure compliance with regulatory requirements to help maintain the safety and efficacy of veterinary products.

Animal health PV services include

• Adverse Drug Experience (ADE) assessment and processing – The systematic evaluation and management of adverse events to ensure patient safety, regulatory compliance, and the ongoing monitoring of drug safety profiles
• FDA Center for Veterinary Medicine (FDA CVM) ADE report preparation and review – Documentation, analysis, and submission of ADE reports related to veterinary products to the FDA CVM
• Signal detection and management – Identification, evaluation, and assessment of potential safety concerns (signals) related to animal health products.
• Single service integration of non-FDA product regulatory needs – Documentation, analysis, and submission of ADE reports related to veterinary products to organizations such as the National Animal Supplement Council (NASC), the Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA), and more

Ensuring Compliance through Effective MI and PV Practices

Compliance with the complex regulatory landscape in veterinary medicine hinges on robust MI and PV practices. Comprehensive MI services ensure that medical inquiries and product complaints are managed in line with regulatory expectations, providing accurate, consistent information and thorough documentation. This helps veterinary companies avoid regulatory pitfalls, such as improper off-label information or inadequate record-keeping.

PV services are equally critical, focusing on the timely identification, assessment, and reporting of ADEs and other safety signals. A proactive approach to these tasks not only meets regulatory requirements but also enhances animal health and safety outcomes.

Robust MI and PV services have benefits that extend beyond compliance. They streamline operations by providing reliable information and swift safety issue resolution, reducing the risk of regulatory actions and boosting stakeholder confidence. By partnering with experts in veterinary medicine and regulatory affairs, companies can ensure they maintain compliance across global regulations, reinforcing their reputation as trusted partners in the veterinary industry.

Partner with ProPharma for Animal Health MI and PV Support

ProPharma’s Animal Health team includes experienced veterinarians, pharmacists, veterinary technicians, and other healthcare professionals. We respond to medical inquiries in a manner that is not only consistent with product labeling and regulatory guidance but also recognizes the connection between animals and people and the importance of communication between interdisciplinary healthcare professionals. Our team has been supporting veterinary and agricultural companies for over 30 years and built expertise in many different regulations.

Veterinary companies can leverage ProPharma’s extensive experience and comprehensive services to ensure their customers receive accurate and complete information about their products promptly. We ensure that any safety or quality information reported to regulatory entities meets all necessary requirements, keeping companies compliant with animal health regulations. Our commitment to excellence helps maintain the highest standards of safety and quality in the industry. Contact us today and tell us how we can support your needs.

Blog Author

Valerie Huh

Director, Global Innovation and Implementation