An In-Depth Discussion on How Chinese Pesticide Companies Can Achieve Joint Registration

Release Date:

2018-06-19

On May 29, 2018, I presented a paper on the topic of “Joint Domestic–International Registration for Products Past Their Patent Terms” at the Third Pesticide Export Registration Summit Forum, which received a positive response within the pesticide industry. Following the event, many colleagues in the sector approached me to discuss whether joint registration for Chinese pesticide companies could indeed be put into practice, how such collaboration could be implemented, and whether Chinese firms could truly set aside their differences and unite to address the complex market dynamics and export‑registration requirements. In fact, as early as October 2015, Mr. Hong Feng, an expert on pesticide export‑registration qualifications, had already published an article on Agropage.

On May 29, 2018, I attended the “Third…” Pesticide At the Export Registration Summit, a presentation was delivered on the topic of “Joint Domestic and International Registration of Products Past Their Patent Term,” in… Pesticide The industry received a positive response. After the meeting, many… Pesticide Industry peers have all come to communicate and discuss China. Pesticide Can the joint registration system for enterprise exports truly be put into practice? And how can such a joint approach be implemented in concrete terms? China. Pesticide Can enterprises truly set aside biases and join forces to tackle the intricate challenges of the market and export registration?
　　In fact, as early as October 2015, Pesticide Mr. Hong Feng, an expert on export registration and industry qualifications, has published an article on Agropage, predicting that China will soon see widespread joint overseas registrations. He also outlined the challenges facing such joint registrations and proposed ways to overcome them (original article link).
　　After 2010, Pesticide The industry has undergone earth-shattering changes, from the merger of DuPont and Dow to Sinochem’s acquisition of Syngenta, and further to Sanonda’s takeover of Adama. The six major agrochemical giants have engaged in mergers and reorganizations, accelerating industry consolidation. By pooling resources and leveraging collective strength, they seek to maximize their respective advantages, achieve win-win outcomes, and enhance competitiveness. Meanwhile, China… Pesticide The industry is facing unprecedented challenges: tightening regulations, mounting environmental pressures, and intensifying competition. Stricter requirements and a more daunting landscape are causing… Pesticide The market has entered a phase of profound restructuring, and domestic companies have increasingly formed alliances to bolster their competitiveness. Notable examples include Xin’an’s acquisition of Zhejiang Jiahua, Lier’s acquisition of Bide Bio, Hongtaiyang’s acquisition of Shandong Kexin, and Heyi Chemical’s acquisition of Jiangsu Changlong. Meanwhile… Pesticide As for whether the market’s “group‑huddling for warmth” approach can also be applied to overseas registration, I believe the answer is yes—and that it can be extended to an even broader scope.
　　China Pesticide Enterprises are Pesticide The investment in registration work is substantial, especially by several major companies. Pesticide The performance breakthrough the company achieved due to registration-related reasons has also motivated the majority. Pesticide Entrepreneurs have increased their investment in registration-related activities. Many companies allocate 5–10% of their gross profit to registration expenses; however, is this substantial capital expenditure being allocated efficiently? Consider two companies… Pesticide For the same active ingredient, a company is required to conduct six acute toxicity tests. Why must these tests be repeated twice in the same laboratory? Why not perform a single test and allow two companies to share the results? China. Pesticide If the profits that companies have painstakingly earned amid adversity were instead channeled into channel investments and the development of end‑market channels, wouldn’t that be even more conducive to growth?
　　Therefore, with regard to how to obtain registration certificates in target countries at the lowest possible cost—and even to overcome regulatory hurdles in the EU and the United States—this author calls on China. Pesticide Enterprises should collaborate to develop distribution channels and target downstream end‑users, capturing the highest profit margins. Specifically, this can begin with joint registration overseas and extend all the way to the final stage. Pesticide Enterprises mobilize their diverse resources and leverage their respective strengths to pursue shared development, thereby transforming China. Pesticide The company aims to enhance its image as a global API manufacturing hub, capture a larger share of market value, and build world‑class, homegrown Chinese brands, thereby fulfilling President Xi’s vision of “shifting from ‘Made in China’ to ‘Created in China,’ from ‘China Speed’ to ‘China Quality,’ and from ‘Chinese Products’ to ‘Chinese Brands.’” It is hoped that one day, China… Pesticide The industry will, like the mobile phone sector, see the emergence of… Pesticide This year’s “Huawei” and “Xiaomi.”
　　So, how should we proceed with implementing joint registration? First, it’s important to note that joint registration among European and American companies is already well established, and Chinese enterprises have also engaged in numerous joint‑registration initiatives within China. When registering in Brazil, some domestic firms have even sought to join foreign task forces. However, participating in these international task forces has presented many challenges for Chinese companies. Differences in registration procedures and practices, coupled with communication barriers and varying interpretations of issues, have led to difficulties adapting to the foreign environment. Moreover, these overseas task forces often prioritize the interests of foreign firms, leaving Chinese companies saddled with annual fees while receiving no commensurate support or services. Consequently, establishing a dedicated task force composed of Chinese enterprises has become imperative—and will undoubtedly become a hallmark of China’s approach. Pesticide A significant opportunity for the further development of enterprises. So, what challenges might arise in implementing joint registration?
　　1. Leakage of trade secrets, trust crisis
　　China Pesticide Confidential business information is frequently leaked, and even the unauthorized disclosure of registered data is commonplace—so much so that some individuals have made it their livelihood, thereby undermining industry norms. Consequently, engaging a professional consulting firm is crucial; such firms do not engage in any commercial activities and focus solely on regulatory compliance. Moreover, a robust confidentiality framework can help manage and mitigate risks related to information security. Nevertheless, fostering collaboration among enterprises ultimately hinges on mutual trust.
　　2. Concern about the emergence of additional competitors
　　To quote Teacher Hong Feng: “The world is vast enough to accommodate several distinct companies.” The reality today is that, as long as a company is willing to invest, there is virtually no registration it cannot complete. Attempting to use registration procedures to restrict competitors is nearly impossible. It would be far more effective to set aside any lingering frictions in overseas registration and instead compete head-to-head on the trade front.
　　3. Partners hold things back
　　Once a joint registration is initiated, any party’s withdrawal midway will disrupt the entire project’s progress. Therefore, ensuring that every partner in the joint registration remains online requires the establishment of clear rules and penalty provisions to enforce compliance. Developing a comprehensive set of regulations and sanctions can effectively safeguard the interests of the jointly registered entity and mitigate risks arising from personnel changes.
　　4. Product quality is uneven, affecting registration.
　　Due to process-related factors, Pesticide The quality of products varies widely among companies, and in some cases, even the samples submitted by firms seeking to participate in a joint registration have not yet been manufactured. Could substandard product quality by certain companies jeopardize the entire joint‑registration project? Consequently, establishing unified standards for products eligible for registration has become critically important.
　　5. Who owns the data and the registration certificate?
　　 Pesticide When an enterprise commissions a laboratory to prepare a test report, the Sponsor may list the names of all co‑registrants to designate the report as jointly owned. For members of a joint registration group, it is possible to internally agree that the test report is shared and may be used without restriction for their own registration purposes. However, if the report needs to be authorized for use by other enterprises outside the joint group, Pesticide Use shall be permitted only with the unanimous consent of all group members. Group members shall exercise joint oversight and assume joint responsibility, and establish uniform disciplinary provisions.
　　The joint registration study primarily focuses on the active ingredient’s toxicological, environmental, and physicochemical assessments; however, five batches of field efficacy trials and residue studies are not included and must be conducted by the applicant company itself. With respect to formulation‑level studies, unless they involve the same formulation, these too are carried out by the applicant company. Each member of the joint registration consortium is required to submit its own complete dossier to the regulatory authorities and ultimately obtain its own registration certificate.
　　In summary, the specific solutions for implementing joint registration are as follows:
　　1. Establish unified statutes and regulations
　　2. Sign a Non-Disclosure Agreement
　　3. Prepayment System
　　4. Registration Fund Establishment
　　5. Financial transparency, with refunds for overpayments and additional charges for underpayments, settled annually.
　　6. Technical Specifications: Establish a Joint Registration SIP
　　7. Pre-screening Samples
　　8. Jointly Conducted Experiments
　　9. Prepare the case file and submit it for official review.
　　10. Obtain their respective registration certificates.
　　At present, I believe that jointly registered products could focus on those nearing the end of their patent terms. On the one hand, these products enjoy promising prospects in the international market, with many… Pesticide Enterprises will all participate. On the other hand, these products are very difficult to register, and the associated costs are substantial, making it worthwhile for China. Pesticide Enterprises are joining forces to resolve registration issues.
　　After the joint registration is completed, Pesticide Enterprises can also pursue deeper levels of collaboration—jointly developing end‑user distribution channels, expanding downstream markets, and even entering into additional cooperation agreements to jointly refine manufacturing processes and launch new products. Accordingly, joint registration serves as a platform for integrating resources and leveraging them in the most efficient and optimal manner, enabling Chinese companies to complete global regulatory filings at minimal cost and risk, enhance their overall competitiveness, and realize their vision of penetrating international markets.