In this overview, I will describe the general process for developing and registering a veterinary product in Europe. This process can also be applied to other parts of the world, respecting each country’s specificities.
The primary goal of a Regulatory Agencies (RA) is to ensure that medicinal products—such as pharmaceuticals, biologicals, vaccines, blood products, and other biologicals—meet standards for quality, safety, and efficacy. The (RA) oversees that these products are manufactured and distributed in a way that maintains their quality until they reach the patient or consumer. They also ensure that commercial promotions are accurate and truthful. Key functions of an RA include registering and licensing products, inspecting and licensing manufacturers, inspecting and licensing distributors, conducting post-marketing surveillance, regulating promotional claims, and authorizing clinical trials.
The main goal of any veterinary pharmaceutical industry is to receive Marketing authorization (registration) for products. This is extremely important and may be one of the industry’s unique characteristics. Without marketing authorization, you can neither sell nor produce this product. Therefore, having a robust regulatory affair in your company is extremely important.
The drug regulatory authorities will review the documentation, focusing on the following to make their own assessment of the documentation submitted regarding the quality, safety, efficacy, and product information of the product based on the file submitted by the applicant. This should always be done for products manufactured in the country.

An essential role of the RA is the inspection and licensing of manufacturers. A license from the RA is mandatory for the production of any medicinal products. Before granting a license, manufacturers must undergo inspections, and follow-up assessments should take place regularly to ensure that their facilities and procedures meet national and international GMP guidelines, as well as any other relevant requirements overseeing the inspection and licensing of distributors, ensuring that every participant in the distribution chain—including importers, wholesalers, and pharmacies—holds a valid license and undergoes regular inspections. This process is vital for maintaining compliance with the specified regulations for obtaining and keeping their licenses.
Post-marketing surveillance is crucial in monitoring product safety by tracking adverse drug reactions. It also involves assessing product quality by collecting samples from manufacturers and the distribution chain at random or in response to concerns about substandard products.
Authorization for clinical trials should only occur after a thorough review of the protocols, ensuring that all necessary approvals are in place. Additionally, there should be a provision to revise or halt the trial whenever participant safety is at risk.
The process of developing a veterinary product begins with identifying a specific idea, problem, or challenge that needs to be addressed. From this, a target should be established, referred to as the Target Product Profile (TPP).
The initial step in any vaccine/product development project aimed at commercialization is to create this TPP. It outlines clear parameters for the desired characteristics of the end product, ensuring that various disciplines are synchronized on necessary outcomes, product attributes, and measures of success. The TPP also serves as a roadmap for the design, execution, and analysis of safety and efficacy trials. This focus allows the development team to describe the vaccine’s or product’s essential features, ensuring that the regulatory trials produce the required data. An effective TPP should define an “Optimal target” and a “Minimal target.” For instance, the optimal target for a dosage schedule might be a single vaccination that provides lifelong immunity. In contrast, a minimally acceptable target could involve a series of vaccinations over a specific timeframe with a more limited duration of immunity.
In our experience, a target dossier profile is a document that greatly helps with developing and registering new drugs. It is typically developed during the discovery phase of veterinary drug development. This phase involves identifying and validating potential drug targets, which is crucial for guiding subsequent research and development efforts.
The Target Dossier is typically developed during the discovery phase of veterinary drug development. This phase involves identifying and validating potential drug targets, which is crucial for guiding subsequent research and development efforts. The dossier is a comprehensive document used in drug discovery and development to compile all critical information about a drug target.
Here’s a brief overview of the stages of veterinary drug development:
- Discovery Phase:
- Identification of potential drug targets.
- Initial research to understand the target’s role in disease.
- Development of the Target Dossier to compile all relevant information.
- Preclinical Development:
- Laboratory and animal studies to assess the safety and efficacy of the drug.
- Refinement of the Target Dossier with new data from these studies.
- Clinical Development:
- We are conducting clinical trials in target animal species.
- Further updates to the Target Dossier based on trial outcomes.
- Regulatory Review and Approval:
- Submission of all data, including the Target Dossier, to regulatory authorities.
- Review and approval process to ensure the drug’s safety and efficacy.
- Post-Approval Monitoring:
- Ongoing monitoring of the drug’s performance in the market.
- Updates to the Target Dossier will be made as new information becomes available.
Flow chart of the significant steps in veterinary drug development

Following the next steps, the Discovery/Feasibility Phase
In developing veterinary vaccines, the Discovery/Feasibility Phase replaces the traditional Preclinical Discovery Phase used for human vaccines. Initial research often takes place in laboratory animals to screen various potential vaccine candidates and identify the most promising formulations. However, laboratory animal models frequently do not accurately represent vaccine safety and effectiveness for the intended species. As a result, veterinary vaccine research generally involves studies directly conducted with the target animals. This direct approach helps pinpoint viable vaccine candidates and offers early insights into the specific efficacy related to the intended product. It enhances our understanding of both the pathogen and the immune response in the target species, which is essential for developing a challenge model that mimics natural infection. This model is crucial for testing the protective efficacy of experimental vaccines or products. Moreover, the veterinary feasibility process will include Proof-of-Concept studies to ensure safety and efficacy within the intended species.
Proof of Concept is typically performed during the early stages of research and development in the development of veterinary vaccines. This phase involves demonstrating that the vaccine candidate can produce the desired immune response in the target species.
Flow chart of the development phase of a vaccine or biological product for an Early Phase.

Early-Phase development
Once there is confidence that the experimental veterinary vaccine candidate elicits an immune response that provides suitable protection, this lead vaccine can be moved into Early-Phase Development. At this stage, it is necessary to prepare and safely store a pre-master Seed and, subsequently, a GMP Master Seed of the chosen production antigen. In doing so, it is important to have clear traceability of the source material, knowledge of all materials used in the handling of the antigen, and documentation to confirm the quality.
The Veterinary Early-Phase Development focuses on key elements of a Regulatory Dossier, particularly Quality (Manufacture), Safety, and Efficacy. The Quality data package must demonstrate the Purity and Consistency of the final manufactured product, ensuring that each batch of vaccine meets its intended purpose. Essential requirements during this stage include detailed qualitative and quantitative information about the vaccine’s components, such as seeds, adjuvants, preservatives, and stabilizers. Additionally, it should provide an overview of the manufacturing process, information on starting materials, certifications confirming freedom from TSEs, quality control tests, a description of batch safety testing, consistency data between batches, stability testing results, and a product release potency test. This potency test, which can be conducted using either in vitro or in vivo assays, ensures the efficacy of the finished vaccine throughout its shelf life and stability. It should adhere to Good Laboratory Practice (GLP) principles, incorporating overdose studies with maximum Titer/potency products on minimum-age animals, pregnant animals, or birds in lay conditions. It also needs to assess the potential for reversion to virulence, biological properties, and any likelihood of recombination.
Moreover, the Efficacy data should encompass studies on the onset and duration of immunity, conducted with minimum Titer/potency products across all animal categories for which the vaccine is designed. During this phase, the pilot-scale manufacturing process should be validated and scaled up to more accurately represent the final manufacturing scale. This will result in three GMP-manufactured consistency batches and a finished filled product suitable for stability tests and field trials.

Late-Phase Development
The Late-Phase Development stage involves applying for a permit to conduct field trials. These trials are crucial for assessing the vaccine’s safety and efficacy in real-world conditions, closely simulating its intended everyday use. This phase is designed to gather comprehensive analytical information, encompassing qualitative and quantitative details about the product.
In addition to product specifics, data related to the vaccine’s safety profile, encompassing any adverse events observed during previous studies, are essential. These field trials should adhere strictly to the guidelines outlined in the VICH Guideline (GL9). Compliance with GCP ensures that the trials are conducted ethically and with a high standard of methodological rigor, which is vital for generating reliable and valid results.
Properly executed field trials inform stakeholders about the vaccine’s performance in varied populations and environments and facilitate the identification of potential safety concerns that may arise outside of controlled clinical settings. This comprehensive approach aims to prepare the product for broader public use while ensuring that any potential risks are thoroughly evaluated and managed.
Late-stage development flow chart

Important notice: the RA agencies have a special focus on it:
Safety: The product must be safe in the target species and, if live, in species exposed to shed organisms;
Efficacy: the product should be effective according to claims indicated on the label; Quality: includes purity, potency, and consistency;
Purity: the product must be free from contaminating agents;
Potency: each product batch should be formulated and tested to ensure activity effectiveness and reproducibility as demonstrated in the registration data.
I have attached below the parts of the dossier that need to be required so that one product can be registered.
Generally, a veterinary dossier is composed of 5 to 6 parts.
- Part 1: Administrative Information:
- Application form
- Summary of the dossier
- Declarations and signatures
- Part 2: Quality Documentation:
- Chemical, pharmaceutical, and biological/microbiological information
- Detailed and critical summaries of the physicochemical, biological, and microbiological documentation
- Part 3: Safety and Residues Documentation:
- Safety tests
- Residue studies
- Detailed and critical summaries on safety and residue documentation
- Part 4: Preclinical and Clinical Documentation:
- Preclinical studies
- Clinical trials
- Detailed and critical summaries on efficacy documentation
- Part 5: Particulars and Documents:
- Additional supporting documents
- Bibliographical references
- Part 6: Specific Requirements for Immunological Products(if applicable):
- Requirements specific to immunological veterinary medicinal products
Registering a pharmaceutical product in Europe can take anywhere from 2 to 4 years, and this timeline can be significantly longer in some regions around the world. Given the lengthy nature of the registration process, it is crucial for the Regulatory Affairs (RA) department to implement effective strategies that can expedite this timeline. These strategies include streamlining communication with regulatory bodies, enhancing data management practices, investing in robust preclinical and clinical trial designs, and ensuring that all necessary documentation is prepared meticulously in advance. Furthermore, fostering strong collaborations with key stakeholders and utilizing regulatory pathways, such as accelerated approval routes, can be vital in speeding up drug registration.
Dossier registration strategies and steps:
Submitting a veterinary dossier in the EU involves several strategic steps to ensure compliance with regulatory requirements. Here’s an overview of the process:
- Pre-Submission Phase
- Early Considerations: Ensure the applicant is established in the European Economic Area (EEA) and consider special support for SMEs.
- Pre-Submission Meetings: Meet with the European Medicines Agency (EMA) to obtain procedural and regulatory advice.
- Preparing the Dossier
- Product Information: Include the product name, prescription status, and detailed product information.
- Quality Documentation: Provide comprehensive data on the product’s chemical, pharmaceutical, and biological properties.
- Safety and Residues Documentation: Include safety tests and residue studies.
- Preclinical and Clinical Documentation: Document preclinical studies and clinical trials.
- Submission and Validation
- Electronic Submission: Use the eSubmission Gateway/Web Client for all procedural submissions to the EMA.
- Validation: Ensure all dossier parts are complete and meet the EMA’s validation criteria2.
- Assessment Phase
- Scientific Review: The dossier undergoes a detailed scientific assessment by the Committee for Medicinal Products for Veterinary Use (CVMP).
- Inspections: Conduct inspections to verify compliance with Good Manufacturing Practices (GMP) and other regulatory standards.
- Approval and Post-Approval
- Marketing Authorization: The EMA grants marketing authorization if the dossier meets all requirements.
- Post-Approval Monitoring: Continue monitoring the product’s safety and efficacy in the market and update the dossier as necessary.
Key Considerations
- Regulatory Guidance: Follow EMA’s guidance documents and templates to ensure all required information is included.
- Timelines: Adhere to recommended submission dates and timelines to avoid delays
Also is important to submit any data in advance for pre-review, this is much appreciated by the authorities and can “buy you some time”, however there are a few steps that you can take to speed up the process:
Pre-Submission Meetings
- Engage Early with EMA: Schedule pre-submission meetings with the European Medicines Agency (EMA) to discuss your data and get procedural advice.
- Scientific Advice: Seek scientific advice from the EMA to ensure your data meets regulatory expectations.
- Rolling Review
- Submit Data in Phases: Use a rolling review process, submitting data as it becomes available rather than waiting for the complete dossier.
- Early Data Submission: Submit preliminary data on quality, safety, and efficacy to allow the EMA to start its review early.
- Union Product Database
- Pre-Submission Data Entry: Enter product data into the Union Product Database early in development.
- Data Enrichment: Continuously update and enrich the data in the database as new information becomes available.
- Conditional Marketing Authorization
- Conditional Approval: Apply for conditional marketing authorization if your product addresses an unmet medical need or is intended for emergencies.
- Post-Approval Commitments: Complete certain studies post-approval to confirm the product’s benefit-risk balance.
- Accelerated Assessment
By strategically submitting early data and engaging with regulatory authorities throughout the process, you can expedite the approval of your veterinary product.

Price estimation of the dossier submission on top of the regular development costs:
Steps |
Fees |
Marketing Authorization Application |
173,000 |
Variation Requiring Assessment |
8,900 |
Scientific Advice |
53,600 |
Annual fee |
42,900 |
Establishment of Maximum Residual Limits |
88,900 |
Reference: |
Fees payable to the European Medicines Agency | European Medicines Agency (EMA) |
Registering a pharmaceutical product in Europe can take anywhere from 2 to 4 years, and this timeline can be significantly longer in some regions around the world. Given the lengthy nature of the registration process, it is crucial for the Regulatory Affairs (RA) department to implement effective strategies that can expedite this timeline. These strategies include streamlining communication with regulatory bodies, enhancing data management practices, investing in robust preclinical and clinical trial designs, and ensuring that all necessary documentation is prepared meticulously in advance. Furthermore, fostering strong collaborations with key stakeholders and utilizing regulatory pathways, such as accelerated approval routes, can also be vital in speeding up the drug registration process.
Below there is a presentation of exemples of dossiers.