Experts Give Top Three Developments for China’s CROs in 2025
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Contract Research Organizations (CROs) are poised to play an increasingly pivotal role in China’s agrochemical industry as it focuses on greener, sustainable technologies. Three industry leaders give their top three developments shaping the dynamic CRO sector in 2025 and a 7-question checklist.
Edward Qin
Business Development Manager
Staphyt
1. Pre-studies support
Chinese CROs need to facilitate pre-studies to help local sponsors understand regulatory projects. Services should include sample screening, impurity confirmation, analytical method development, and synthesis of impurity samples.
2. Synergy in export-only registrations
Since 2019, China ICAMA’s export-only registration category allows sponsors to use a single project to support both domestic and international registrations, minimizing duplicate studies and ensuring data consistency.
3. Collaboration with overseas GLP Labs
Chinese CROs excel in chemistry-related studies and often subcontract biological studies to labs in destination countries, ensuring compliance with local regulatory practices.
Ada Lee
Founder and Managing Director
Jinan Sunrise Agrotech Co., Ltd.
1.Innovative products
The demand for local trials is rising, pushing the development of local trial agencies and field trials from CROs.
2.Synergy analysis
Conducting synergy analysis for product launches is critical, driving CROs to align trials and registrations with local needs.
3.Diversified registration support
Forming clusters to support complex registration processes helps overcome local practices and language barriers.
Daisy Hu
Principal Regulatory Affairs Consultant
Reach24H
1. Green and biological pesticides
The rising demand for eco-friendly and sustainable solutions, including microcapsule suspensions and biological pesticides, means CROs must respond to the country’s green agriculture goals. “China’s commitment to green agriculture and sustainable development is driving CROs to innovate, from low-toxicity formulations to precision-release technologies, all while ensuring compliance with both local and international standards,” says Hu.
2.Enhanced service capabilities
CROs must have expanded alignment with international standards, supporting multi-country registrations for efficient dual-market compliance.
3.Digital innovations
Integration of artificial intelligence and digital tools for streamlined project management and improved data accuracy is essential when working with a CRO in 2025.
China CRO 7-Question Checklist
As China’s regulatory environment evolves, CROs remain essential partners for companies aiming to navigate complex requirements and achieve successful product registrations. When selecting a CRO, consider the suggested questions from our three experts.
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Does the CRO have familiarity with MARA guidelines and international standards?
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Have you verified the CRO’s experience in relevant product categories and complex projects?
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Does the CRO have robust communication frameworks and issue-resolution mechanisms?
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Does the CRO understand the equivalence criteria and regulatory requirements for this project?
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Can the dossier be used for global submissions in core markets like the EU, U.S., Brazil, and Australia?
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Can the CRO assist with sample evaluation, impurity standard acquisition, and method development? Do they have adequate experience for addressing governmental inquiries?
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Does the CRO have strong coordination skills to meet the varying demands of different provinces?
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