New Veterinary Drug Registration Guidelines in China - Effective from January 2025

China's regulatory landscape for veterinary drug registration continues to evolve, with new measures introduced to streamline processes and ensure higher standards of compliance. The Veterinary Drug Evaluation Center of the Ministry of Agriculture and Rural Affairs (MARA) has issued new guidelines aimed at strengthening the management of veterinary drug registrations.

The "Measures for Handling Non-compliant Veterinary Drug Registration Application Document (Trial Implementation)" was released in late December 2024 and are set to come into effect on January 1, 2025.

Key Points of the New Veterinary Drug Registration Guidelines

The new guidelines emphasize the importance of ensuring that all application documents are thorough, precise, and aligned with regulatory requirements. This is crucial to maintaining the integrity of the veterinary drug registration process and safeguarding public health.

1) Comprehensive and Accurate Submissions Required

The guidelines emphasize the need for veterinary drug registration applications to be complete and precise. All documents must meet the specific requirements outlined in existing regulations, such as the Veterinary Drug Administration Regulations and Veterinary Drug Registration Measures.

One of the key aspects stressed is the necessity for data to be authentic and reliable, helping to safeguard the integrity of the registration process.

2) Handling Non-compliance

The guidelines outline specific scenarios where registration materials might be considered non-compliant. These include:

1. Inconsistencies in written text, formulas, charts, or images.
2. Modify the review test quality standards or report to the Ministry of Agriculture and Rural Affairs for approval in the process of standardized documents, the operation of the art form, the attached list, etc., repeated modifications, no test basis.
3. New veterinary biological products registration information compared with the clinical reporting information, the product process parameters changed, resulting in changes in the main components of the product; change adjuvant, freeze-dried protective agent formula, raw and auxiliary materials, the proportion of preparation, concentration (purification) methods.
4. Unsubstantiated changes to safety, efficacy, or quality-related data in multiple applications for the same product.
5. Pilot product batch production inspection records and process protocols in the key steps or key parameters, test standards are inconsistent.
6. The existence of unreasonable shared data or data similarity in the test reports of different product declaration information.
7. The existence of subcontracting in the project of the clinical trial organization of Chinese and chemical drugs; the existence of errors in the same kind of report, pointed out by the review, the new test report still appears similar problems.
8. Misuse of data in reports for different products or experiments.

3) On-Site Inspections and Accountability

Should there be repeated issues with non-compliance, the guidelines call for on-site inspections to verify the accuracy of the data and the adherence to required procedures. The findings from these inspections will be critical to the technical review of applications.

If any fraudulent practices are identified during these inspections, the relevant authorities are instructed to take appropriate actions in accordance with Chinese regulations.

4) Improved Registration Review Process

By focusing on the accuracy and consistency of submitted materials, the new guidelines are designed to enhance the overall efficiency of the drug registration review process. This could result in faster approval times for compliant applications, benefiting companies that invest in ensuring their documentation meets the highest standards.

Implications for International Companies

For companies seeking to enter the Chinese market with veterinary drugs, these updates underscore the increasing importance of regulatory compliance. As China’s regulatory framework becomes more structured and focused on data integrity, companies may find themselves facing stricter requirements during the registration process.

If documents are found to be non-compliant, applicants may receive formal notifications, be placed on a monitoring list, or even face on-site inspections. Persistent issues or suspected data falsification could result in application rejections and heightened scrutiny for future submissions.

Companies must take proactive steps to mitigate these risks and ensure a smooth approval process.

1) Proactive Compliance:Ensuring that all application materials are accurate, consistent, and based on validated research will be critical for success. Regulatory affairs teams will need to implement stringent internal processes for reviewing submission documents.

2) Preparedness for Inspections:Companies may need to adjust their approach to documentation to anticipate potential on-site inspections, which could involve more detailed examinations of manufacturing processes, clinical trials, and product testing protocols.

3) Ongoing Monitoring:Staying informed about updates to regulatory requirements and ensuring that all staff involved in submissions are trained to understand the nuances of the Chinese regulatory environment will be essential for minimizing risks of non-compliance.

Conclusion

As China continues to refine its veterinary drug registration system, regulatory affairs and compliance managers will need to stay abreast of these changes to ensure that their companies remain competitive and compliant in this vital market.By adhering to the new guidelines, companies can help streamline the approval process, avoid delays, and position themselves for success in the growing Chinese veterinary drug sector.

Further Information

To read the MARA's Notification of the Measures for Handling Irregularities in the Registration of Veterinary Drugs, please click here.

If you are interested in how these veterinary drug registration guidelines might impact your organization, please contact Cisema for more information.

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