Veterinary pharmaceuticals, referred to as veterinary drugs under China’s regulatory framework, are regulated by the Ministry of Agriculture and Rural Affairs (MARA). Companies involved in their manufacture, import or marketing must comply with applicable requirements for registration, quality, safety and Good Manufacturing Practice (GMP).
This guide covers the veterinary drug regulatory framework in China, including the registration process, key regulatory requirements, and the approval pathways for new and imported veterinary drugs.
Regulatory Authority for Veterinary Drugs in China
The Ministry of Agriculture and Rural Affairs (MARA) is the Veterinary Pharmaceutical Regulatory Authority of China. Under the Regulations on Administration of Veterinary Drugs, the competent veterinary administrative department under the State Council is responsible for national veterinary-drug supervision and administration. In contrast, competent veterinary authorities of people’s governments at or above the county level are responsible for veterinary-drug supervision and administration within their respective jurisdictions.
Role of MARA in Veterinary Drug Regulation
MARA is responsible for national-level veterinary-drug administration and plays a central role in the review and approval of new veterinary drugs and imported veterinary drugs. The Measures for Registration of Veterinary Drugs provide that the competent agricultural authority is responsible for national veterinary-drug registration, while the veterinary-drug review and testing system supports the technical evaluation and verification process.
MARA also establishes and administers requirements relating to veterinary GMP, product quality, veterinary-drug standards, and safety oversight. Recent MARA announcements demonstrate that the authority continues to approve new veterinary drugs, registrations, changes, and re-registrations and to issue or revise associated quality standards, manufacturing processes, labels, and package inserts.
Veterinary Drug Regulations in China
Under China’s veterinary-drug regulatory framework, companies need to meet requirements that include the following:
- Get product approval prior to manufacturing, importing, or marketing veterinary drugs in China.
- Produce products in a manufacturing facility that meets the GMP requirements.
- Perform necessary safety, efficacy, and (if applicable) clinical trials for product registration.
- Prior to commercialization, use labels and package inserts that are approved by MARA and are in Chinese.
- Follow post-market monitoring and report safety issues (throughout the product lifecycle).
- Veterinary medicines for import must be registered in China and comply with the Chinese standards for manufacturing and quality.
Veterinary drugs intended to be exported to China for the first time must undergo registration. The requirements include evidence of approval for manufacture or marketing in the country of origin, GMP certification, manufacturing and quality information, pharmacological and toxicological data, clinical-trial information, and stability data. For products used in food-producing animals, information concerning withdrawal periods, maximum residue limits, and residue-testing methods may also be required.
Veterinary Drug Registration Process in China
MARA is responsible for national veterinary drug registration. The China Veterinary Drug Approval Process contains dossier submission, technical evaluation, product testing, and regulatory evaluation. The specific requirements depend on whether the product is a new veterinary drug, an imported veterinary drug, a registered veterinary drug undergoing a change, or another category covered by the applicable regulations.
Each requirement is detailed in the sections below.
Documents Required for Veterinary Drug Registration
The applicants are required to submit a registration dossier to MARA. The dossier normally consists of:
- Application form
- Formulation, composition, and manufacturing process of products
- Analytical methods and specifications or quality standards validated
- Information on safety, such as toxicology and target animal safety information
- Efficacy data, such as pharmacology study reports, clinical study reports, etc.
- Stability study data to support shelf life
- GMP certificate or manufacturing requirements
- Product labels and package inserts in Chinese
- Samples for lab testing as needed by MARA
- Certificate of Free Sale or related evidence from the country of origin (for imported products)
- GMP certification issued by the competent authority in the country or region where the manufacturer is located for imported products.
For imported veterinary drugs, MARA’s published requirements additionally identify samples, inspection/testing records, and reports from three consecutive batches, as well as additional information for biological veterinary products where applicable.
The technical evaluation is based on the submitted information and applicable Chinese veterinary-drug standards and registration requirements.
Veterinary Clinical Trial Requirements
The clinical and safety requirements vary according to the product and registration pathway. Typically, new veterinary drugs might need the following:
- Target animal safety studies
- Efficacy studies
- If applicable, clinical trial data will be used.
- Pharmacological and toxicological information
- Supporting study data and other technical information required for evaluation
Evidence is reviewed by MARA during the technical evaluation. If necessary, more information will be requested.
Veterinary GMP Requirements
Before going into production, manufacturers will need to meet the veterinary GMP Requirements of China. Applicants should provide the following:
- Appropriate personnel, premises, facilities, and equipment
- A quality-assurance system and comprehensive documentation
- Validated manufacturing processes and relevant process controls
- Appropriate quality-control procedures and testing
- Batch records and traceability information
- Procedures for deviations, complaints, recalls, and corrective measures
- Appropriate storage and distribution controls.
The 2020 GMP framework also contains specific requirements for different categories of veterinary drugs. MARA issued separate special GMP requirements for sterile veterinary drugs, non-sterile veterinary drugs, veterinary biological products, APIs, and traditional Chinese-medicine preparations.
For imported products, the overseas manufacturing site must provide the applicable GMP certification and manufacturing information required for imported-veterinary-drug registration. MARA may also conduct an on-site inspection of the overseas manufacturer during the examination process were considered necessary.
Veterinary Drug Labelling Requirements
The official Measures for Administration of Veterinary Drug Labels and Package Inserts require veterinary-drug labels and package inserts to contain prescribed information and prohibit unauthorized changes or additions. Required information may include the following:
- Product name
- Active ingredients
- Strength or packaging information
- Manufacturer details
- Approval number or applicable imported-veterinary-drug registration certificate number
- Batch number
- Manufacturing & expiry date
- Indications and dosage
- Withdrawal period (if indicated).
- Storage conditions
- Precautions
Chinese is required for the text used on veterinary-drug labels and package inserts, with foreign-language text permitted as a supplementary translation where appropriate. The rules also require the information to be truthful and accurate and prohibit unauthorized or exaggerated claims.
Recent MARA registration announcements continue to issue or revise product quality standards, manufacturing processes, package inserts, and labels as part of veterinary-drug registration and post-registration changes.
Veterinary Drug Approval Timelines
There is no single approval timeline applicable to every veterinary drug registration in China. The overall review period is based on the following:
- Product category & registration pathway
- Completeness and quality of the submitted dossier
- Technical evaluation
- Product testing
- Clinical or safety data requirements
- Use of requests for additional information
- Whether the application concerns a new, imported, amended, or re-registered veterinary drug
Applicants should therefore avoid publishing a fixed number of days unless it is tied to a specific regulatory procedure and current official service standard.
Veterinary Drug Registration Fees
Registration and evaluation may involve applicable government fees depending on the type of application and regulatory service. Applicants are advised to check the most recent fee schedule with MARA before applying, as fee amounts are subject to change.
Veterinary Drug Import Requirements in China
Under China’s veterinary-drug import framework, a veterinary drug being exported to China for the first time must generally obtain an Imported Veterinary Drug Registration Certificate through the applicable registration procedure.
Typically, applicants are required to submit the following:
- Evidence of product approval in the country of origin
- Overseas GMP certificate
- The company’s manufacturing process and quality standards.
- Analytical methods
- Pharmacology and toxicology data
- Clinical study reports
- Stability data
- Withdrawal period and residues for products of animal origin for food
- Samples to be sent for official tests (if applicable)
As part of the approval procedure, MARA might be required to inspect the overseas manufacturing plant.
An important additional requirement is that foreign enterprises cannot directly sell veterinary drugs in China. Under the Regulations on Administration of Veterinary Drugs, an overseas enterprise intending to sell veterinary drugs in China must establish a sales office in China or authorize a qualifying agency within China.
For imported veterinary biologics, an additional import-permission procedure applies after registration. The Chinese importer must obtain the applicable import documentation and complete the relevant customs procedures.
PMS & Pharmacovigilance Requirements for Veterinary Products
Veterinary-drug manufacturers and other relevant parties have obligations relating to the collection, reporting, and handling of information concerning veterinary-drug adverse reactions. The Regulations on Administration of Veterinary Drugs provide penalties where veterinary-drug manufacturers, distributors, users, or prescribing veterinarians fail to report serious adverse reactions as required. They also require manufacturers of new veterinary drugs during the monitoring period to collect and report information concerning efficacy and adverse reactions.
Post-market activities may therefore include:
- Monitoring the safety and efficacy of veterinary products
- Recording and evaluating adverse reactions
- Reporting serious adverse reactions to the relevant veterinary authorities
- Maintaining relevant records
- Taking corrective or remedial measures when required.
These activities support continued veterinary-drug safety oversight throughout the product lifecycle.
Conclusion
To meet the requirements of Veterinary Drug Regulations in China, careful planning and understanding of MARA’s requirements are necessary. An adequate registration approach can decrease delays and help with quicker entry into the market.
Artixio has many years’ experience in helping veterinary companies with Regulatory Affairs Consulting Services in China. Get end-to-end regulatory support, from regulatory strategy and dossier preparation to product registration and post-approval compliance. To know more, get in touch with us today at info@artixio.com.
FAQs
1. Who regulates veterinary pharmaceuticals in China?
The Ministry of Agriculture and Rural Affairs (MARA) is the Veterinary Pharmaceutical Regulatory Authority of China. Competent veterinary authorities at the provincial and local levels also have responsibilities for veterinary-drug supervision and administration within their respective jurisdictions.
2. What are the Veterinary Drug Registration Requirements in China?
The application will include a registration dossier with quality, safety, efficacy, and manufacturing information. Product testing, GMP compliance, and technical data may also be conditions for approval with MARA.
