Japan has a well-defined framework for veterinary medicines. For global regulatory teams and animal health companies, however, meeting the requirements of Veterinary Drug Regulations in Japan can be difficult. Registration requirements can sometimes be complicated by country-specific approval, manufacturing, and compliance requirements.
This guide is a general explanation of the Veterinary Drug Regulations in Japan. It includes the regulatory authorities, registration process, documentation, and requirements for successful entry into the market.
Regulatory Authority for Veterinary Pharmaceuticals in Japan
The Ministry of Agriculture, Forestry and Fisheries (MAFF) is the Veterinary Pharmaceutical Regulatory Authority in Japan. It regulates veterinary medicines, and the National Veterinary Assay Laboratory (NVAL) aids in scientific review of applications.
Role and Responsibilities of the Ministry of Agriculture, Forestry, and Fisheries (MAFF) in Veterinary Drug Regulation
Both bodies are responsible for different roles:
MAFF’s responsibilities are to:
- Approval of veterinary drugs prior to market.
- Control of veterinary medication production, import, and distribution.
- Setting up standards for quality, safety, and effectiveness.
- Responsible for post-marketing surveillance and pharmacovigilance activities.
NVAL’s support of MAFF includes:
- Reviewing registration dossiers.
- Carrying out GMP audits and technical assessments.
- Testing veterinary pharmaceutical products to ensure they meet regulatory standards.
Veterinary Pharmaceuticals Regulations in Japan
The veterinary drug regulations are established under the Pharmaceuticals and Medical Devices (PMD) Act and its related ministerial ordinances in Japan. It guarantees that veterinary medicines meet the necessary requirements. This is required to ensure quality, safety, and efficacy prior to manufacture, import, marketing, and use in Japan.
To register Veterinary Drugs in Japan, manufacturers are required to meet the following requirements:
- Product quality, safety, and efficacy
- Manufacturing and GMP compliance
- Collection of clinical and non-clinical data.
- Labeling and packaging standards.
- Marketing authorization
- Post-marketing surveillance and pharmacovigilance.
- Import and distribution regulations
The amount of data and review time varies by product type and risk profile.
Veterinary Pharmaceuticals Registration Process in Japan
To manufacture, import, or market a veterinary medicine in Japan, companies must have both a license and marketing approval.
Step 1: Determine the Regulatory Pathway
Determine the product type (new drug, generic, biological, etc.) and the approval process. This helps in deciding the data and testing needed for the application.
Step 2: Prepare the Registration Dossier
Prepare the application file for quality, safety, efficacy, manufacturing, and labeling. Supporting documents must meet the requirements of MAFF and NVAL.
Step 3: Submit the Application
Send the marketing authorization application to MAFF. The submitted dossier is reviewed and coordinated by NVAL.
Step 4: Technical Review and Inspections
NVAL reviews the quality, safety, and efficacy data. It also validates GLP, GCP, and GMP compliance by conducting document reviews and/or inspections, as appropriate.
Step 5: Obtain Marketing Approval
When NVAL reviews the product and it is recommended to be approved for marketing by relevant advisory committees, MAFF will give marketing approval.
Step 6: Post-Approval Compliance
Once approval is granted, the companies will be subject to post-marketing obligations, such as pharmacovigilance, product quality monitoring, and re-evaluation requirements throughout the product lifecycle.
Recent Updates to Japan’s Veterinary Pharmaceutical Regulations
An updated PMD Act was amended by MAFF and the National Veterinary Assay Laboratory (NVAL) in May 2026. Key updates include:
- As of now, clinical real-world data can be used to support applications for approval, re-examination, and post-marketing evaluation, subject to regulatory requirements.
- All veterinary biological products may be subject to document-only inspection, as appropriate.
- Some specifications and test methods are now acceptable according to the standards set by the European Pharmacopoeia (EP) and United States Pharmacopeia (USP) without adapting to the standards set by the Japanese Pharmacopoeia (JP).
- Approval applications are less comprehensive for ruminant-derived materials, due to the lower global risk of BSE.
- The GLP documentation requirements have been reduced to align with the current inspection practices.
- The National Assay has been superseded by the term “Inspection” in the regulatory system, and products do not need to be marked with the “Passed National Assay” notation.
Note: MAFF regularly issues notifications and guidance updates. It is helpful to review the latest circulars before preparing or submitting a registration dossier to ensure compliance with current requirements.
Documents Required for Veterinary Pharmaceuticals Registration
The documents needed for Veterinary Drug Registration Requirements Japan vary depending on the type of product and the presence of a new active ingredient. A typical application consists of:
- Marketing authorization application form
- Compliance with product specifications and production details
- Quality (CMC) documentation
- Non-clinical safety data
- Chemical efficacy and safety data (where available)
- Product specifications and methods of testing.
- Stability data
- Proposed labeling and package inserts
- GMP compliance documents
- Risk management or post-marketing plans, as appropriate
The review process may require further information from MAFF and NVAL depending on the nature of the product or its intended use.
Veterinary Clinical Trial Requirements for Pharma Products in Japan
Veterinary Clinical Trial Requirements in Japan depend on the product and supporting evidence available. Sponsors are required to provide clinical information on the safety and effectiveness of the new veterinary drug in the species for which it is intended.
Clinical studies should comply with Japan’s Good Clinical Practice (GCP) requirements. During the review process, NVAL also conducts GCP and GLP inspections to ensure the reliability of clinical and non-clinical data.
Veterinary GMP Requirements for Pharma Manufacturing in Japan
Before a product can be approved for manufacture or import, manufacturers have to be compliant with Veterinary GMP Requirements in Japan. NVAL checks the consistency of manufacturing and quality control processes with the GMP requirements set forth in Japanese laws.
Some critical requirements for Key GMP are:
- A compliant quality management system.
- Formulated manufacturing and quality controls.
- Skilled staff and appropriate manufacturing equipment.
- Documented procedures and batch records.
- Completed GMP inspections or (where applicable) document-based assessments.
Foreign manufacturers who supply products to Japan should also undergo the Veterinary Drug Manufacturing License Japan and approval process under GMP compliance.
Veterinary Drug Import Requirements in Japan
Commercial importation of veterinary medicines into Japan is subject to Veterinary Drug Import Requirements Japan under the PMD Act.
Key requirements include:
- Possess a marketing authorization and an import and sale business license by MAFF.
- Import products manufactured at approved GMP-compliant facilities.
- Finalize customs clearance and deliver import paperwork.
- Ensure imported products comply with the approved specifications and labeling.
Veterinary Drug Labelling Requirements in Japan
Veterinary Drug Labelling Requirements Japan requires approved products to be labelled prior to sale, based on the MAFF requirements.
The label and package insert typically include:
- Product name
- Active ingredient(s) and strength
- Dosing and directions for use
- Target animal species
- Storage conditions
- The batch number and the expiry date are given.
- Details of the manufacturer or marketing authorization holder.
- Warning, precautions, and withdrawal period (if applicable)
Timeline for Veterinary Drug Approval in Japan
The timeline will depend on the product type, data quality, and the need for additional information from MAFF and/or NVAL in the review.
A typical timeline is:
- Dossier preparation: 3–6 months
- MAFF/NVAL technical review: 9–18 months
- GMP inspections and deficiency responses (if applicable): Varies by product
- Marketing approval: After successful completion of the scientific review and regulatory assessment.
Fees for Veterinary Pharmaceuticals Registration in Japan
Japan does not publish a single consolidated fee schedule for Veterinary Drug Registration in Japan. The total cost depends on the type of application and the regulatory activities involved.
Applicants may incur fees for:
- Manufacturing/Marketing Business License: Registration tax of JPY 150,000 per application.
- Manufacturing License: Registration tax of JPY 90,000 per manufacturing category.
- License renewal and amendment fees, where applicable.
- GMP inspections, testing, and other regulatory activities, depending on the application.
MAFF and NVAL do not publish a standard scientific review fee for veterinary product marketing authorization. Applicants should confirm the applicable fees based on their product type and regulatory pathway before submission.
PMS & Pharmacovigilance Requirements for Veterinary Products
After approval, marketing authorization holders must comply with Veterinary Drug Post Marketing Surveillance Japan throughout the product lifecycle. MAFF uses these activities to continuously monitor the safety, quality, and effectiveness of veterinary medicines.
Key post-marketing requirements include:
- Monitor and evaluate adverse events.
- Report serious safety issues to MAFF.
- Conduct post-marketing surveillance or use-results surveys when required.
- Maintain product quality throughout commercial distribution.
- Support re-examination or re-evaluation of products when requested by MAFF.
Conclusion
If you are looking for registration of a new product or growing your animal health portfolio, it can help to work with local experts in the field. It delivers not only reduced review delays but also compliance with the changing regulatory requirements of Japan. Explore Artixio’s regulatory and market access services in Japan for broader support across pharmaceuticals, medical devices, cosmetics, and other regulated products.
With Artixio, you can access end-to-end regulatory consulting services in Japan. Our experts support regulatory strategy, dossier preparation, MAFF submissions, GMP compliance, import support, and post-approval obligations for veterinary pharmaceutical products. Achieve faster and compliant market access for animal health products. Contact us at info@artixio.com to learn more.
FAQs
Who regulates veterinary drugs in Japan?
The Ministry of Agriculture, Forestry and Fisheries (MAFF) is the primary regulatory authority. The National Veterinary Assay Laboratory (NVAL) conducts the scientific review, technical evaluations, and GMP inspections that support MAFF’s approval decisions.
How do I register a veterinary drug in Japan?
The process involves determining the regulatory pathway, preparing the registration dossier, submitting the application to MAFF, completing the NVAL technical review, and obtaining marketing approval.
What documents are required for Veterinary Drug Registration in Japan?
Typical documents include quality (CMC) data, safety and efficacy studies, manufacturing information, GMP evidence, stability data, labeling, and administrative application forms.
Are local clinical trials mandatory in Japan?
Not always. MAFF determines the clinical data requirements based on the product type, available evidence, and whether foreign data are considered acceptable.
How long does veterinary drug approval take in Japan?
The review timeline typically ranges from 9 to 18 months, although it may vary depending on the product type, dossier quality, and regulatory queries.
Do foreign manufacturers need GMP certification?
Yes. Overseas manufacturing facilities supplying veterinary medicines to Japan must demonstrate compliance with Japan’s veterinary GMP requirements.
What are the post-marketing obligations after approval?
Marketing authorization holders must comply with adverse event reporting, post-marketing surveillance, product quality monitoring, and any re-examination or re-evaluation requirements imposed by MAFF.
