China MARA Releases 7th Edition Veterinary Pharmacopoeia Volume III

On October 16, 2026, China’s Ministry of Agriculture and Rural Affairs published Announcement No. 1073, releasing Volume III of the Veterinary Pharmacopoeia of the People’s Republic of China (Seventh Edition).

Effective May 1, 2027, Volume III establishes statutory technical standards for veterinary biological products, covering development, manufacturing, importation, distribution, use, testing, and regulatory supervision. Its requirements affect product quality standards, testing methods, safety evaluation, immunogenicity, and strain documentation.

Foreign manufacturers and veterinary drug registration holders should review existing registrations to identify compliance gaps and determine whether technical revisions or formal registration changes are necessary.

Scope and Impact on Existing Products

Volume III comprises general provisions, product monographs, and appendices. Its product monographs establish national standards for groups of veterinary biological products based on individual antigens.

For imported veterinary biological products, the new requirements have three main implications:

• New registrations: Applications submitted from May 1, 2027, must comply with the applicable requirements of Volume III, including technical documentation and testing.
• Existing registrations: Products whose approved registration standards are less stringent than Volume III may require technical updates and formal change registration.
• Standard changes: Registration holders must provide technical information and data for relevant bacterial, viral, or parasitic strains where required to bring their approved registration standards into conformity with Volume III.

Products not covered by the new volume may continue to follow their existing standards if those standards have not been formally abolished. However, they must still comply with the applicable general requirements of Volume III.

Implementation Timeline and Transitional Arrangements

The transition rules distinguish between products manufactured before and after the effective date and applications submitted during the transition period.

• Manufactured on or before April 30, 2027: Products may continue to be tested under previous quality standards and circulated and used until the end of their shelf life.
• Manufactured from May 1, 2027: Products must comply with Volume III and the applicable MARA-approved veterinary drug registration standard.
• Applications submitted on or before April 30, 2027: Sample inspection reports may be based on either the original registration standard or a newly MARA-approved standard that meets the updated requirements.
• Applications from May 1, 2027: New registrations and relevant approval-number applications and renewals must meet the applicable updated requirements.

Companies should align testing and submission schedules with these deadlines, particularly where existing standards require revision.

Assessing and Updating Existing Registration Standards

Registration holders must compare their approved product standards with Volume III and conduct comparison studies where the existing requirements are less stringent. The findings will determine whether changes can be implemented internally or require formal registration.

Potential gaps include:

• External-virus testing methods and requirements.
• Safety testing for bacterial, viral, or parasitic strains and finished products.
• Immunogenicity testing, including animal numbers and acceptance criteria.
• Strain identification, characterization, and supporting technical documentation.
• Finished-product quality standards and acceptance criteria.

Company-Led Revisions Without Registration Approval

Certain revisions may be implemented without registration approval, provided they fall within the permitted categories and satisfy applicable requirements. These include:

• Revising general testing methods and requirements, including external-virus testing
• Adjusting animal numbers for bacterial, viral, or parasitic strain and finished-product safety testing in accordance with pharmacopoeia requirements
• Adjusting animal numbers in immunogenicity testing where acceptance criteria remain unaffected
• Adding animal species for finished-product safety testing
• Making editorial changes that do not affect critical technical indicators

Companies must confirm or validate the changes, update relevant quality standards, manufacturing procedures, and testing procedures, and complete internal approvals in accordance with Good Manufacturing Practice (GMP) requirements.

Changes Requiring Formal Registration

Formal change registration is required when existing registration standards fall below the new pharmacopoeia requirements. Relevant cases include:

• Missing testing items or less stringent acceptance criteria for bacterial, viral, or parasitic strains
• Testing methods that differ from the pharmacopoeia and provide less stringent requirements
• Insufficient animal species for strain safety testing
• Insufficient animal numbers in immunogenicity testing where acceptance criteria are affected
• Finished-product quality standards that do not meet Volume III requirements

For imported veterinary biological products, companies must complete the necessary comparison studies and submit change-registration applications under the applicable veterinary drug registration procedures.

Products requiring formal change registration cannot continue to be produced or imported until registration is completed. Companies should therefore identify affected products early and allow sufficient time for technical work and regulatory approval.

Approval-Number Applications and Renewals

Announcement No. 1073 also establishes requirements for veterinary drug approval-number applications and renewals.

From May 1, 2027:

• New applications: Approval-number applications for veterinary biological products must use a MARA-approved registration standard that complies with Volume III as the basis for sample testing.
• Renewals: Applications to renew veterinary drug approval numbers must include technical documentation demonstrating compliance with the updated requirements.

Companies should coordinate sample testing and submission schedules with any necessary registration-standard changes to avoid delays in approval-number applications or renewals.

Final Thoughts

The Seventh Edition Veterinary Pharmacopoeia, Volume III, introduces updated standards that may require changes to imported veterinary biological products and their registrations in China. Manufacturers should complete their compliance assessments early, prioritize changes requiring formal approval, and incorporate regulatory timelines into production and import planning.

Cisema can help manufacturers assess compliance gaps, determine the appropriate change pathway, and prepare the technical documentation required for internal revisions or formal registration.

For support with compliance assessments, technical documentation, and registration changes under the new pharmacopoeia requirements, contact Cisema today.

Further Information

• Explore Cisema’s China veterinary drug registration services.
• Read about China’s registration guidelines for veterinary drugs.

References

• Ministry of Agriculture and Rural Affairs of the People’s Republic of China, Announcement No. 1073, releasing Volume III of the Veterinary Pharmacopoeia of the People’s Republic of China (Seventh Edition).农业农村部公告 第1073号（发布《中华人民共和国兽药典（第七版）三部》）