New Regulatory Standards for Protein-Based Veterinary Medicines in China Take Effect

On March 19, 2025, the Veterinary Medicine Evaluation Center of the Ministry of Agriculture and Rural Affairs issued a notice standardizing the classification and evaluation requirements for protein-based new veterinary medicines. Effective immediately, the regulation requires all newly applied protein-based veterinary products to comply with the latest classification standards. The notice clarifies the application pathways based on production methods and product characteristics, impacting how international manufacturers must prepare their submissions for the Chinese market. This regulatory update introduces both compliance challenges and strategic considerations for overseas applicants and underscores the importance of aligning with current evaluation criteria when entering or operating within China’s veterinary pharmaceutical sector.

Introduction

To advance innovation in veterinary medicine and align with evolving clinical needs, the Ministry of Agriculture and Rural Affairs has introduced new classification standards for protein-based veterinary medicines. This move forms part of China's broader regulatory reform aimed at improving the accuracy, safety, and scientific rigor of veterinary drug evaluations.

The notice, issued by the Veterinary Medicine Evaluation Center and approved by the Animal Husbandry and Veterinary Bureau, provides detailed technical criteria for determining whether a protein-based product should be registered under the biological products category or as a chemical drug. Classification is now more tightly linked to the product’s source, manufacturing method, and mechanism of action.

Specifically, products derived through bacterial or cell expression systems, or extracted from biological fluids, are now clearly categorized as biological products, while others may qualify as chemical drugs if they align with international evaluation standards in terms of safety and efficacy. This clarification aims to streamline the application process, reduce ambiguity, and ensure regulatory consistency across submissions.

Given China's role as a growing market for veterinary pharmaceuticals, this new regulation has implications for international manufacturers looking to introduce protein-based products. The following sections outline the core elements of the new requirements, potential impacts for overseas applicants, and key strategic actions to support compliance and successful market access.

Key Points of the New Regulation

The new regulation details the application classification standards for protein-based new Veterinary Medicines and clarifies the requirements for different types of protein-based new Veterinary Medicines. This helps reduce ambiguity in the application process and improve application efficiency. According to the notice, the application for protein-based new Veterinary Medicines needs to more strictly follow the classification standards to ensure the accuracy and completeness of the application materials.

From a broader perspective, this change is part of China's continuous improvement of its veterinary medicine supervision system. In recent years, China has taken a series of measures in veterinary medicine quality supervision to enhance the safety and effectiveness of Veterinary Medicines. The implementation of this new regulation further reflects China's determination to standardize the management of the veterinary medicine market.

Main Impacts on Overseas Manufacturers

1. Compliance costs may increase

For international veterinary medicine manufacturers already selling in the Chinese market or planning to enter it, the new regulation brings new challenges and opportunities. On the one hand, stricter standards mean companies need to invest more time and resources to prepare application materials to ensure their products meet China's regulatory requirements. On the other hand, the new regulation also provides companies with an opportunity to showcase their product quality and R&D capabilities.

International manufacturers need to pay special attention to the strengthened supervision of imported Veterinary Medicines under the new regulation. This means greater emphasis on compliance during the application process to avoid application failures due to non-compliance. Production sites may be subject to on-site inspections by Chinese regulatory authorities, or international GMP certification equivalence certificates may be required.

2. Market entry cycles may be revised

The new regulation's stricter classification and application requirements for protein-based new Veterinary Medicines raise the market entry threshold, which will generally be considered a net positive for overseas manufacturers who already comply with stricter requirements. On the other hand, for some local manufacturers with weaker technical capabilities or insufficient regulatory awareness, this may pose greater challenges. They need to improve in areas such as R&D, production, and quality control to meet the regulatory requirements of the Chinese market.

• Innovative products will enjoy greater market access but at least in initial stages may face extended approval times as the new regulation is implemented.

• Biosimilars require more stringent consistency evaluations, which may increase R&D and application costs.

3. Market competition landscape adjustment

Low-level repetitive applications will be restricted, making products with genuine technological innovation more likely to gain approval. The importance of intellectual property protection is heightened, and international companies need to plan regulatory and patent strategies carefully.

Recommendations for Overseas Manufacturers

1. Accurately assess product classification and optimize application strategies

• Companies should collaborate with professional institutions as early as possible to clarify whether their product is "innovative," "improved," or a "biosimilar" to develop an application path that complies with Chinese regulations.

2. Enhance product quality

• The implementation of the new regulation provides an opportunity for companies to enhance product quality. International manufacturers can improve competitiveness by optimizing production processes and strengthening quality control. Consider collaborating with Chinese laboratories or clinical trial institutions to supplement key data for the Chinese market. Ensure production processes and quality control systems meet the requirements of China's veterinary medicine GMP.

3. Strengthen regulatory management

• International manufacturers should enhance their learning and understanding of China's veterinary medicine regulations to ensure application materials fully comply with the new regulatory requirements. Additionally, companies need to establish internal regulatory mechanisms to regularly conduct self-inspections of product quality and production processes to ensure compliance with China's regulatory standards.

4. Seek professional consultation

• Faced with complex regulatory changes, international manufacturers can seek assistance from professional consulting firms. These firms can provide services such as regulatory interpretation and application process guidance to help companies better address the challenges brought by the new regulations.

Opportunities for Global Manufacturers

The new veterinary medicine regulations released by the Ministry of Agriculture and Rural Affairs reflect the continuous improvement of China's veterinary medicine supervision system. Although these new regulations pose certain challenges for international manufacturers, they also provide opportunities for companies to enhance product quality and competitiveness. By strengthening regulatory learning, management, product quality improvement, and seeking professional consultation, international manufacturers can better adapt to the changes brought by the new regulations and ensure the smooth sale of their products in the Chinese market.

Further Information

To read the original China Institute of Veterinary medicine Control announcement for implementing new classification requirements for protein-based veterinary medicines, please click here.

If you are a veterinary medicine manufacturer with questions about how the new classification affects your product registration for the China market, please contact Cisema.

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