One Health Framework in Veterinary Medicine & Regulations

In recent years, regulatory conversations within the life sciences sector have increasingly emphasized the importance of a unified approach to human, animal, and environmental health what is now commonly referred to as the One Health framework. Far from being a conceptual model, One Health has become a practical foundation influencing regulatory policies worldwide, particularly in the veterinary and animal health space. For organizations engaged in pharmaceutical, veterinary, or food production sectors, this shift presents both a strategic consideration and a regulatory imperative. The role of veterinary regulations is expanding in scope and significance, directly contributing to how global health challenges are being addressed from antimicrobial resistance to zoonotic disease outbreaks and environmental contamination.

Let’s take a closer look at how this framework is shaping regulatory expectations and what it means for companies operating across human and animal health domains.

Understanding One Health in Regulatory Context

One Health is based on the understanding that the health of humans, animals, and the environment are deeply interdependent. This is not a theoretical observation, it’s supported by growing evidence linking animal farming practices to antimicrobial resistance, or wildlife exposure to the emergence of zoonotic diseases like avian influenza and potentially COVID-19.

In response, regulatory agencies are implementing more integrated health oversight mechanisms. These are designed to support not only animal health and welfare but also human public health, food safety, and environmental sustainability.

Veterinary Regulations

Veterinary regulatory frameworks have traditionally focused on the safety, efficacy, and quality of veterinary medicinal products. However, under the lens of One Health, these frameworks are being re-evaluated and reinforced to achieve broader public health goals.

Some key regulatory institutions involved include:

FDA Center for Veterinary Medicine (CVM) in the U.S., which oversees animal drug approval and safety monitoring.

USDA APHIS Veterinary Services, focusing on animal disease control and trade.

European Medicines Agency (EMA), implementing Regulation (EU) 2019/6, which strengthens pharmacovigilance and harmonizes veterinary drug regulations across EU member states.

International bodies such as the World Organisation for Animal Health (WOAH) and Codex Alimentarius, which provide guidance on global standards.

Each of these bodies is aligning its regulatory priorities to reflect the shared risks and responsibilities inherent in the One Health model.

Key Areas of Regulatory Convergence Under One Health

Antimicrobial Resistance (AMR) Control

Regulatory agencies have introduced specific measures to control the use of antimicrobials in animals. This includes prohibiting the use of medically important antibiotics for growth promotion and implementing prescription-only access for critical drugs.

Veterinary product submissions now require detailed justification of antimicrobial use, and sponsors must demonstrate risk management strategies, particularly in relation to public health. Surveillance of antimicrobial consumption and resistance patterns in animals has also become a regulatory expectation in many countries.

Management of Zoonotic Diseases

Outbreaks of diseases that transmit between animals and humans have prompted stronger coordination between animal health and public health systems. Regulatory frameworks now emphasize early detection, surveillance, and rapid response mechanisms. In regions like the EU, disease monitoring data from veterinary systems directly inform public health risk assessments.

Veterinary biologicals such as vaccines are under increased scrutiny, and their approval processes are closely aligned with national disease control strategies.

Food Safety and Residue Control

Regulators are reinforcing policies around food-producing animals, particularly with respect to veterinary drug residues in meat, milk, and eggs. Risk assessments for Maximum Residue Limits (MRLs) are now routinely conducted with human exposure in mind.

Sponsors must provide comprehensive residue depletion data during veterinary drug development, and compliance monitoring continues post-approval via national residue surveillance programs.

Environmental Impact Assessments

Veterinary products that may enter the environment especially antiparasitics and antimicrobials are evaluated for their ecological impact. Agencies such as EMA require applicants to conduct detailed environmental risk assessments (ERAs) as part of the marketing authorization process.

This includes modelling of predicted environmental concentrations and potential effects on soil, aquatic organisms, and non-target species.

What This Means for Industry Stakeholders

For companies developing or marketing animal health products, the regulatory landscape is clearly evolving. Compliance requirements are expanding to reflect a more interconnected understanding of health risks. This affects dossier preparation, clinical study design, risk management planning, post-marketing surveillance, and environmental documentation.

From a strategic perspective, companies must ensure that regulatory submissions are scientifically robust and aligned with current expectations—not just for product safety and efficacy, but for broader societal health outcomes.

For organizations operating across both human and animal health sectors, this alignment with One Health principles may require cross-functional regulatory teams, integrated data systems, and a proactive engagement with regulators at both national and international levels.

About DDReg

We work closely with companies to interpret and implement regulatory requirements within the One Health paradigm.

Our capabilities include end-to-end regulatory support for veterinary drug and vaccine submissions, expertise in antimicrobial resistance documentation and risk mitigation, environmental risk assessment planning and study design, pharmacovigilance system setup and operation for veterinary products, submission strategy across multi-country and regional frameworks (e.g., EU, GCC, ASEAN). For expert regulatory guidance, connect with our team today.