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What Is a Benefit-Risk Analysis?
From the title of the guideline, it is evident that a dominant aspect of the document is the benefit-risk analysis for veterinary medicinal products, and while this might sound straightforward, when it comes to assessing veterinary medicinal products, it is more complicated than just looking at a product and determining if it is good or not for animals and humans. A good benefit-risk analysis must offer a systematic approach to determine if a veterinary medicinal product actually does what it claims and if these ‘benefits’ are worth the ‘risks,’ which must always be outweighed by the benefits. Regulatory authorities perform these checks not just before granting authorization but throughout the product's entire lifecycle to ensure continued human, animal, and environmental safety by assessing the scientific data backing the benefits and whether they justify the risks. After a product has been granted authorization, owners and veterinarians also contribute to this analysis by reporting adverse effects and observing long-term effects of the treatment.
Why Are The Changes Coming Now and What Does It Mean For The Industry?
Animals play a key role in our lives not just as pets but also in the agricultural sector as sources of food, labor, and raw materials, sustaining sub-industries like dairy and meat, which billions rely on for nutrition around the globe. To safeguard animals, the people that interact with them, and their surroundings, as well as address growing concerns over resistance and environmental issues, the CVMP has been working toward systematic benefit-risk evaluation standards to eliminate inconsistencies across EU member states and offer a clearer framework for assessing veterinary medicinal products.
With the new changes in effect, pharmaceutical companies must now submit more comprehensive data not just during the market authorization process but at multiple stages of a product’s lifecycle, allowing authorities to conduct closer post-market evaluations to determine whether a product’s benefits continue to outweigh its risks. This means that even if a product has been granted authorization, it can still be revoked post-authorization if regulatory assessments later deem it to be riskier than beneficial.
While the spotlight is largely focused on manufacturers, owners and veterinarians are also affected, as certain products deemed high-risk post-authorization will now require additional safety measures to align with regulatory safety and treatment protocols.
How the New Regulation Will Work and Be Monitored
As highlighted earlier, the new guideline puts an emphasis on a structured, multi-step approach to ensure veterinary medicinal products undergo thorough scrutiny before regulatory approval and throughout their lifecycle. Pharmaceutical companies must now go to deep lengths to demonstrate that their products offer the benefits they claim to have while minimizing all potential risks before seeking approval. Using the data from the submitted documentation, clinical trials, the national regulatory bodies and the EMA will assess these products based on scientific data to reach a conclusion on their safety, efficacy, and overall benefit-risk balance. Once a product gets the green light for use in the EU, it is continuously monitored for safety and efficacy to determine if it is safe for continued use.
With the product in use and on the market, Marketing Authorization Holders (MAH) are tasked with the responsibility of monitoring and reporting adverse effects, resistance patterns, and any newly identified risks to authorities within the stipulated timeframe in line with industry regulations. In the event of a new or heightened risk emerging, authorities, based on the severity of the risk, may request additional studies, impose restrictions, or revoke the product’s authorization altogether.
To reinforce the continuous monitoring of these products, in addition to the pharmacovigilance database that contains safety reports from veterinarians, pharmaceutical companies, and regulatory agencies across the EU, manufacturers must also submit yearly safety reports detailing any emerging concerns and how they plan to address them, ensuring an industry-wide proactive rather than reactive approach to managing veterinary product safety. This new methodology to pharmacovigilance puts companies at the forefront of proactively engaging in risk assessment and mitigation, rather than waiting for regulatory intervention, which is a big step in the early detection of risks.
What To Expect After May 2025
Once the regulation kicks in after May 15, 2025, veterinary medicine manufacturers and other industry stakeholders are expected to play additional roles in line with the updated responsibilities and obligations. While manufacturers should expect a more rigorous approval process and more requirements to submit extensive clinical trial data, environmental risk assessments, and antimicrobial resistance studies, veterinarians and animal owners must prepare for potential changes that might affect medicine availability. Due to the strict monitoring, some veterinary products already in use may be withdrawn or face new restrictions if they are deemed risky, which will impact how they are prescribed and administered.
What You Can Do To Prepare
With the updated EMA Guideline on the Evaluation of the Benefit-Risk Balance of Veterinary Medicinal Products coming into effect on May 15, 2025, manufacturers of veterinary medicinal products must now go the extra mile to ensure they are fully compliant with the updated regulations to avoid penalties and disruptions. In addition to assessing products for compliance and safety, updating documentation, and strengthening pharmacovigilance systems, companies must also refine their benefit-risk evaluation methodologies to ensure all risk factors that might have been previously overlooked are addressed. Keeping up with new guidelines, regulations, and industry changes is never easy, especially in an industry as dynamic as the life sciences.
That is why, at PQE Group, we have dedicated our entire existence to doing all the heavy lifting for pharmaceutical companies like yours, so you don’t have to. Our pharmacovigilance and regulatory affairs experts have spent decades navigating the industry, so you can rely on us to help you with the new EMA benefit-risk guidelines for veterinary medicine and other regulatory challenges.
