Jinan Zhuocheng Bio-Tech Co., Ltd.

Veterinary APIs are the starting point of the veterinary pharmaceutical supply chain. Their regulatory compliance has a direct impact on the safety of food derived from animals and broader public health.

In recent years, China has continued to strengthen veterinary drug supervision across the production, distribution, and use stages, while international regulators are working toward greater alignment of technical requirements through organizations such as the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

China: Increasingly Comprehensive Oversight of Veterinary APIs

China's veterinary API regulatory framework is primarily based on the Regulations on Administration of Veterinary Drugs, supported by regulations and technical requirements including the Good Manufacturing Practice for Veterinary Drugs (2020 Revision) and the Measures for the Administration of Veterinary Drug Product Approval Numbers.

Together, these requirements establish a regulatory framework covering veterinary drug manufacturing, distribution, and use.

Under China's veterinary GMP requirements, manufacturers are expected to establish comprehensive quality assurance systems. Each batch must be reviewed and approved by the person responsible for quality before release. Manufacturing activities must be documented, deviations must be investigated and recorded, and batch records and electronic traceability information must provide a complete history of the relevant batch.

Material storage is also subject to specific requirements. Solid and liquid materials should be stored separately where applicable, volatile materials must be managed to prevent cross-contamination, and materials without a specified expiry period are generally subject to a storage period of no more than three years before re-testing.

Manufacturing Access: GMP and Product Approval Requirements

Veterinary drug manufacturers in China must obtain the relevant manufacturing qualifications, and products must fall within the approved scope of their veterinary drug manufacturing licenses.

For products subject to product approval-number requirements, manufacturers must complete the relevant application, testing, and regulatory review procedures before commercial production and distribution.

Veterinary APIs are also subject to specific controls on their distribution channels.

Under China's regulatory requirements, veterinary APIs are intended for supply to veterinary drug manufacturers and should not be directly sold to livestock farms or individual animal keepers. Unauthorized repackaging or retail-style distribution is also restricted.

These requirements are particularly relevant to API exporters and international suppliers working with Chinese veterinary pharmaceutical manufacturers.

Use of Veterinary APIs: Direct Use in Livestock Production Is a Key Compliance Issue

China's veterinary drug supervision has increasingly extended from manufacturing and distribution to the actual use of veterinary medicines in animal production.

Since 2023, Chinese authorities have carried out campaigns aimed at standardizing veterinary drug use in livestock and poultry production, with subsequent actions designed to consolidate and strengthen enforcement.

One important area of enforcement is the direct use of APIs in animal production.

Veterinary APIs are generally not intended to be administered directly to livestock or poultry as substitutes for approved veterinary formulations. Authorities have also focused on practices such as excessive dosage, use beyond the approved scope, and use beyond the specified treatment period.

This creates an important distinction for API suppliers: manufacturing and supplying a compliant API is only one part of the regulatory chain. The downstream use and distribution of that API must also comply with applicable veterinary drug requirements.

Online Distribution Is Becoming an Important Regulatory Focus

Online sales have created additional channels for veterinary drug distribution, and regulators have increasingly incorporated online business activities into veterinary drug enforcement.

Particular attention has been given to unauthorized online sales of veterinary APIs, including the repackaging or sale of APIs to entities other than qualified veterinary drug manufacturers.

The connection between online transactions and China's veterinary drug traceability system is also becoming increasingly important.

For manufacturers and distributors, this means that inventory records, transaction information, traceability codes, and distribution destinations need to remain consistent and auditable throughout the supply chain.

Additional Considerations for Imported APIs

Companies supplying APIs to the Chinese veterinary pharmaceutical market also need to distinguish between veterinary APIs and APIs regulated as human pharmaceutical substances.

For certain situations involving the addition of domestic API suppliers to imported veterinary drug products, Chinese regulatory authorities have clarified that veterinary APIs may require the relevant veterinary drug approval number, while APIs regulated as pharmaceutical substances for human medicines may be subject to pharmaceutical approval or registration requirements.

The distinction is important for companies operating across both human pharmaceutical and animal health supply chains, particularly when the same active substance may be used in different regulatory contexts.

International Regulation: Different Systems, Increasing Technical Alignment

Outside China, veterinary pharmaceutical regulation is organized differently across major markets. However, there is a broader trend toward greater international coordination of technical requirements.

European Union: GMP and Centralized Regulatory Frameworks

In the European Union, veterinary medicinal products are regulated primarily under Regulation (EU) 2019/6.

The regulatory framework covers areas including manufacturing, quality management, distribution, pharmacovigilance, and marketing authorization.

GMP requirements for active substances cover key areas such as facilities, equipment, materials, manufacturing operations, quality control, and documentation.

One important characteristic of the EU system is cooperation among national competent authorities. GMP inspection results can be recognized within the EU framework, helping reduce unnecessary duplication of inspections across member states.

For veterinary medicinal products, the EU also provides several marketing authorization routes, including national authorization, mutual recognition, decentralized procedures, and the centralized procedure.

The European Medicines Agency (EMA), through its Committee for Veterinary Medicinal Products (CVMP), plays an important role in the scientific evaluation and regulatory framework for veterinary medicines, including areas such as maximum residue limits and veterinary medicinal product assessments.

United States: FDA Oversight and VICH Alignment

In the United States, veterinary medicinal products are regulated by the U.S. Food and Drug Administration (FDA) through its Center for Veterinary Medicine (CVM).

In January 2024, FDA published a draft guidance, GFI #286 (VICH GL60), concerning good manufacturing practice for veterinary active pharmaceutical ingredients.

The guidance is based substantially on the principles established in the human pharmaceutical API framework, including ICH Q7, and represents part of the broader effort to establish internationally aligned GMP expectations for veterinary APIs.

The development of VICH guidelines is particularly important in this context.

Established in 1996, VICH provides a framework for cooperation among regulatory authorities and industry representatives from the European Union, Japan, and the United States.

Its broader objective is to reduce unnecessary differences in technical requirements for veterinary medicinal products and facilitate more predictable regulatory processes across major markets.

For international API manufacturers, greater alignment can potentially reduce duplicated technical work. At the same time, harmonization also means that manufacturers need to meet a more systematic set of quality and compliance expectations.

Veterinary Pharmacopoeial and Quality Standards

Although regulatory systems differ between countries and regions, pharmacopoeial standards remain an important part of veterinary pharmaceutical quality control.

China uses the Chinese Veterinary Pharmacopoeia as a major reference for veterinary drug quality standards, supplemented by relevant national and registration standards.

In the United States, veterinary drug quality standards are largely incorporated into the United States Pharmacopeia (USP) framework rather than through a separate veterinary pharmacopoeia.

The European Union and Japan also maintain their own pharmacopoeial and regulatory systems, while international organizations such as the World Health Organization (WHO) and the World Organisation for Animal Health (WOAH) provide broader technical guidance from public health and animal health perspectives.

For exporters, understanding these differences is essential because compliance with a domestic standard does not automatically mean that an API satisfies every requirement of a target export market.

Regulatory Trends for Veterinary API Manufacturers

The regulatory direction in China is increasingly moving beyond the manufacturing site itself toward the entire product lifecycle.

At the domestic level, traceability and control of distribution channels are becoming increasingly important. Direct use of APIs in animal production and unauthorized online distribution are among the areas receiving greater regulatory attention.

At the international level, technical harmonization through VICH continues to influence the development of veterinary pharmaceutical standards. Draft documents such as GFI #286 illustrate the direction toward more consistent expectations for veterinary API manufacturing and GMP inspection.

For Chinese veterinary API manufacturers serving international markets, this creates two parallel compliance priorities.

The first is domestic traceability and distribution control.

The second is international GMP capability and alignment with relevant global technical standards.

These requirements are increasingly interconnected. A manufacturer seeking to develop long-term international customers needs not only stable API quality and production capacity, but also a documented quality system, reliable traceability, controlled distribution channels, and the ability to demonstrate compliance with the regulatory expectations of its target markets.

As veterinary pharmaceutical regulation continues to evolve, regulatory compliance is becoming less of a supporting function and more of a fundamental part of the competitiveness of veterinary API manufacturers.