Optimizing China’s System for Protecting Pesticide Registration Test Data from an International Perspective

The pesticide registration system reflects the government’s administrative oversight of pesticides entering the market, as well as its regulation of their quality, safety, and efficacy. For pesticide‑development companies, launching a new product requires conducting a series of complex laboratory, greenhouse, and field trials, entailing substantial R&D investment. When applying for pesticide registration, such companies must submit authentic, comprehensive, and reliable data, documentation, and samples to demonstrate the product’s safety, effectiveness, and controllable quality. Given the low success rate of new‑pesticide development, the trial data submitted during the registration process carries significant commercial value. To safeguard the proprietary information disclosed by pesticide developers during the registration process, many developed countries and regions grant these companies a period of intellectual‑property protection. One of the primary objectives of the pesticide IP regime is to strike a balance among protecting market access for pesticide firms, incentivizing innovation, and ensuring affordability and the public‑health‑oriented nature of plant‑protection services. This paper examines the practices of developed countries regarding the protection of pesticide‑registration trial data and puts forward preliminary proposals for safeguarding such data in China at this stage, intended as a reference for industry stakeholders.

01

Basic Principles of Data Protection for Pesticide Registration Trials

The World Trade Organization (WTO) underscores the importance of intellectual property. As a WTO member, China should adopt and enforce measures to effectively protect intellectual property rights related to pesticides, including systems for the protection of pesticide‑related test data. Accordingly, the intellectual property regime for pesticides not only contributes to the stable development of trade among WTO members but also plays a crucial role in China’s efforts to build an innovation‑driven nation and promote high‑quality economic growth.

1.1 The Origins of Chemical Substance Test Data Protection

In 1993, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), established under the WTO framework, for the first time mandated, at the international law level, that WTO members provide a minimum standard of protection for undisclosed pharmaceutical test data. In order to join the WTO, the State Council, in its Working Party Report on China’s Accession—publicly released in January 2002—committed that: “To comply with Article 39(3) of the TRIPS Agreement, China will afford effective protection against unfair commercial use of undisclosed test data or other data submitted as required to the competent Chinese authorities for the purpose of obtaining marketing authorization for pharmaceuticals or agricultural chemicals containing new chemical entities, except where disclosure of such data is necessary to protect the public interest or where measures have been taken to prevent their unfair commercial use. This protection shall include the adoption and enforcement of laws and regulations ensuring that, from the date the Chinese government grants marketing authorization to the data provider, no one other than the data provider may, without the latter’s consent, use such data to apply for marketing authorization for the same product for a period of at least six years. During this period, any second applicant seeking marketing authorization may be granted such authorization only upon submission of its own data. All pharmaceuticals or agricultural chemicals containing new chemical entities shall be eligible for this type of data protection, regardless of whether they are protected by patents.” Guided by this provision and in response to the requirements of WTO accession, China promptly incorporated provisions safeguarding new compounds into its laws and regulations governing pharmaceuticals, veterinary medicines, pesticides, and other sectors, with a uniform protection term of six years.

1.2 Protecting the Interests of Pesticide Researchers and Developers

Pesticide trial data constitute a type of research outcome that is distinct from patent‑protected inventions, and they represent critical, confidential information that pesticide developers must submit to obtain marketing authorization. Prior to market approval, such data may be safeguarded as trade secrets by the developing company; however, once the product is on the market, these trial data must be disclosed to the national pesticide regulatory authority, thereby forfeiting their protection as trade secrets. To recognize and incentivize the substantial efforts invested in generating pesticide trial data, a protective regime grants the developer exclusive rights to use and exploit those data for a specified period, while prohibiting others from relying on them in their own marketing‑authorization applications. Although pesticide trial‑data protection is not inherently linked to patent protection, it nonetheless constitutes an important component of the intellectual property framework.

02

Current Status of Data Protection for Pesticide Registration Trials in China

Since China introduced its pesticide registration system in 1982, there has been no requirement for the protection of pesticide registration‑test data. With the promulgation of the first “Regulations on the Administration of Pesticides,” the former Ministry of Agriculture issued the departmental regulation “Measures for the Implementation of the Regulations on the Administration of Pesticides,” which, for the first time, established data‑protection provisions for new pesticides, new formulations, and new uses and application methods. In 2001, China revised the “Regulations on the Administration of Pesticides,” and, for the first time, enshrined in State Council regulations a six‑year data‑protection period for new pesticide registrations; this provision has remained in force to the present day.

2.1 Regulating the protection of pesticide registration test data at the level of pesticide legislation

On May 8, 1997, China promulgated for the first time the Regulations on the Administration of Pesticides, which are a State Council regulation. To align with the requirements of WTO accession, the Regulations were revised for the first time on November 29, 2001, through the Decision of the State Council on Amending the Regulations on the Administration of Pesticides. A specific provision was added to the pesticide registration section concerning the protection of data on new pesticides, stipulating: The State shall protect the test data and other proprietary data submitted by applicants for the first registration of pesticides containing new compounds, provided such data have been obtained by the applicant and remain undisclosed. From the date of registration, for a period of six years, no other applicant may, without the consent of the registered applicant, use the aforementioned data in applying for pesticide registration; however, this restriction does not apply where the other applicant submits data independently obtained. Except in the following circumstances, the registration authority shall not disclose the data specified in the preceding paragraph: (1) when required by public interest; or (2) when measures have been taken to ensure that such information will not be improperly used for commercial purposes. The Regulations on the Administration of Pesticides were further revised at the 164th Executive Meeting of the State Council on February 8, 2017, and underwent a second amendment on March 29, 2022, through the Decision of the State Council on Amending and Repealing Certain Administrative Regulations. The provisions safeguarding pesticide registration test data have remained in force to this day.

2.2 Regulating the protection of pesticide registration test data at the level of departmental regulations on pesticides

To facilitate the implementation of the Regulations on the Administration of Pesticides and to draw on relevant provisions of the laws, regulations, and systems of developed countries and international organizations, the former Ministry of Agriculture issued, on April 27, 1999, the Departmental Regulation on the Implementation Measures for the Regulations on the Administration of Pesticides. This regulation, for the first time, established a policy of protecting test data for the registration of new pesticides, new formulations, and new uses and application methods, providing protection periods of seven years, five years, and three years, respectively, for test data pertaining to new pesticides, new formulations, and new scopes of use and methods. On December 19, 2017, the “List of Regulations and Normative Documents Abolished by the Ministry of Agriculture” repealed the Regulations on the Implementation Measures for the Regulations on the Administration of Pesticides (promulgated by Order No. 20 of the Ministry of Agriculture on July 23, 1999, and subsequently amended by Orders No. 18 of July 27, 2002, No. 38 of July 1, 2004, and No. 9 of December 8, 2007).

A “new pesticide” refers to active ingredients and formulated products—both domestic and foreign—that have not yet been approved for registration in China. Within a seven-year period, if two technical-grade active ingredients of the same pesticide are registered, the first one to be registered is considered a new pesticide, while the second is no longer classified as such but remains protected under the pesticide registration system. A “new formulation” is a product that contains the same active ingredient as an already registered pesticide, but whose formulation type or concentration (ratio) has not yet been registered in China. Such a product is granted registration upon its initial application submitted in accordance with the requirements for amendment registration. The technical-grade active ingredient used must itself be registered, and the applicant must provide evidence demonstrating that the active ingredient originates from a registered manufacturer; the protection period for such a formulation is five years. A “new use or method” refers to a situation where both the active ingredient and the formulation are identical to those already registered, but the intended use or application method has not yet been registered in China. This applies to pesticides for which the registered active ingredient and formulation are being used for the first time in a new purpose or mode of action, as requested through an amendment registration; the protection period for such products is three years.

03

Regulations on the Protection of Pesticide Registration Test Data in Developed Countries

Many developed countries worldwide have early on incorporated systems for the protection of pesticide registration‑test data into their relevant pesticide‑management laws and regulations. As a component of intellectual property, the protection of pesticide registration data has now become a key issue of growing concern in pesticide registration management, the cross‑border registration of agrochemical products, and international trade.

3.1 United States

With respect to the protection of pesticide registration data, the U.S. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) includes provisions for data exclusivity. For the first registrant of a single‑ingredient or formulated product containing a new active ingredient, data exclusivity is granted for 10 years from the date of registration. Within seven years of product approval, each additional minor‑crop registration added extends the period of exclusivity by one year, with a maximum total duration of 13 years. Once the exclusivity period has expired, applicants may still seek a new 10‑year period of exclusive use by submitting new data to support minor‑crop registrations; such new data typically include residue‑metabolism and environmental‑ecology information. Regarding data‑compensation mechanisms, FIFRA also provides for reimbursement of research and development costs associated with registration data. Generally, there are two scenarios: compensable data encompass all materials submitted in support of registration, including field efficacy studies, new‑use applications, re‑registration submissions, and other relevant information; the compensation period is typically 15 years from the date of filing. If the applicant for an identical product fails to reach an agreement with the original registrant on compensation, arbitration may be initiated.

3.2 European Union

Regulation (EU) No 1107/2009 of the European Parliament and of the Council is the principal legal instrument governing the registration of plant protection products in the European Union and serves as a guiding framework for risk assessment and product evaluation across EU member states. Pesticide registration in the EU operates on two levels: active substances (technical-grade materials) are registered at the EU level, with uniform applicability throughout the Union, while formulated products are registered separately in each member state. With respect to active‑substance registration, data protection generally lasts 10 years from the date of the first EU‑level registration; within five years of product registration, an additional three‑month extension may be granted by expanding the scope of minor‑crop registration, bringing the maximum protection period to 13 years. For low‑risk pesticides, the protection period is 13 years, with a cap of 15 years. As for formulated‑product registration, data protection extends for up to 10 years from the date of the first registration in each member state, though the exact start and end dates of the protection period may vary among member states.

3.3 Japan

Two thousand years ago, Japan implemented a policy of permanent protection for pesticide registration data, prohibiting second‑party applicants from referencing the original registrant’s information. In the same year, the Ministry of Agriculture, Forestry and Fisheries issued a notice introducing provisions for the registration of identical products. In 2001, the Ministry further stipulated that original registration data would be protected for at least 15 years. The original registrant could either grant authorization or decline to do so. If a formulation has been registered for more than 15 years, applicants seeking registration of an identical product may refer to certain portions of the original registrant’s data; however, extensive original‑active‑ingredient and formulation data—including some acute toxicity studies, subchronic and chronic toxicity data, carcinogenicity, teratogenicity, and mutagenicity studies, as well as environmental toxicity information—must still be supported by the applicant through their own test reports.

04

Recommendations for the Protection of Pesticide Registration Test Data in China

As a component of pesticide intellectual property, the protection of pesticide registration‑test data in China has been in place for more than two decades, yet it has applied solely to new chemical entities. This approach is no longer aligned with the current state of the pesticide industry, the level of research and development capabilities, the economic strength of enterprises, or the stage of market‑economy development; therefore, it is necessary to appropriately revise the policy on the protection of pesticide registration‑test data.

4.1 Extending the Data Protection Period for Registration Studies from the Perspective of Pesticide Registration Categories

The launch of a new pesticide product requires passing through stages such as testing, demonstration, and market promotion; typically, it takes 8 to 10 years for the product to reach maturity. Under the current regime, the protection period for pesticide registration data is six years—by which time the product has only just gained market acceptance, and its brand effect may not yet be fully realized. Meanwhile, other companies begin preliminary registration studies two years before the protection period expires, and by the time the six-year term ends, a large number of identical products are registered, often triggering unhealthy competition in the market. Precisely because the existing data‑protection period is short, the first registrant is compelled to license its data in order to maximize economic returns. If the protection period were appropriately extended, the initial registrant would have less incentive to broadly license its proprietary test data, thereby exercising more prudent control over the number of licensed entities. This would lead to a more rational distribution and scale of registrations for similar products. At the same time, it would significantly reduce the number of identical products registered using exempted or reduced‑data requirements, since the pioneer company would already hold the market’s initiative, prompting later entrants to focus less on registering identical products and instead invest in developing novel active ingredients, innovative formulations, and expanded uses and application methods—efforts that likewise demand substantial human, material, and financial resources. Accordingly, we recommend adjusting the data‑protection period for pesticide registration: ten years for new pesticides, with an appropriate extension of 6 to 8 years for data covering new uses, new application methods, and environmentally friendly novel formulations. Such an approach would both safeguard the interests of the first registrant and foster the sound, sustainable development of the pesticide industry.

4.2 Adjusting the Data Protection Period for Registration Trials from the Perspective of Pesticide Registration Risks

The Regulations on the Administration of Pesticides stipulate that the state encourages and supports the research, production, and use of pesticides that are safe, efficient, and economical. Meanwhile, the Measures for the Administration of Pesticide Registration require accelerating the phase-out of pesticides posing high risks to agriculture, forestry, human and animal health, agricultural product quality and safety, and the ecological environment. Application dossiers must meet the requirements of risk assessment and benefit evaluation, demonstrating that the product exhibits clear comparative advantages over already‑registered products in terms of safety, efficacy, and cost‑effectiveness. When reviewing registration applications and referring to the toxicity, residue, and environmental approval data of previously registered products, the principle of maximum risk shall be followed. The Fourteenth Five-Year Plan for Pesticide Industry Development further emphasizes that developing low‑toxicity, highly effective, and environmentally friendly pesticides is an inevitable trend. Accordingly, during pesticide registration reviews, it is customary to clearly define risk‑assessment indicators and standards; for example, environmental considerations should address impacts on bees, birds, fish, silkworms, and ecological toxicity; toxicological assessments should evaluate human and animal exposure risks; residue evaluations should focus on food‑chain safety for humans and animals, as well as appropriate pre‑harvest intervals for fresh produce; and efficacy evaluations should examine issues such as resistance development and crop injury. Pesticide risk levels should be scientifically and reasonably determined, typically categorized into high, medium, and low risk. Except for urgently needed pesticides, high‑risk pesticides are generally prohibited from registration, medium‑risk pesticides are subject to strict registration controls, and low‑risk pesticides are encouraged to be registered. Drawing on international practice, for pesticides classified as medium or higher risk, the data‑protection period for new‑pesticide registrations may be set at 10 years; for low‑risk pesticides, a longer protection period—such as 12 to 13 years—may be granted. This approach not only incentivizes the first developers but also helps mitigate adverse effects on humans, livestock, and the environment, thereby sustaining green and high‑quality agricultural development.

4.3 Extending the data protection period for registration trials from the perspective of pesticide registration for specialty minor crops

In recent years, with the rapid development of China’s socio‑economic landscape and modern agriculture, the intensification, centralization, and scaling-up of specialty minor‑crop cultivation have steadily increased. In some regions, this has progressed to “one product per county,” “one product per township,” and even “one product per village,” turning these crops into locally distinctive economic staples that play a vital role in supporting regional economic growth. Most specialty minor crops are characterized by high added value, significant economic returns, and strong profitability, thereby assuming an increasingly important position in agricultural production and export trade. Common examples include coarse grains and oilseed crops, traditional Chinese medicinal herbs, fungi, as well as specialty vegetables and fruits; addressing pest, disease, and weed management for these crops has become a key priority in agricultural production. In July 2013, the former Pesticide Testing Institute of the Ministry of Agriculture convened a national kickoff meeting on the safe use of pesticides for vegetable and specialty crops in Changchun, Jilin Province. Jilin was among the first to initiate pesticide‑use trials for ginseng, followed later by provinces and autonomous regions such as Zhejiang, Jiangsu, Shandong, and Ningxia. To address the issue of “no registered pesticides available” for specialty minor crops, the state has implemented a series of measures. On the funding front, the central government has allocated dedicated subsidies to support experimental expenses for these crops, while provincial governments have also earmarked special funds—e.g., Zhejiang provides subsidies covering 50% of registration‑trial costs for crops like bayberry, mulberry, and Hangbai chrysanthemum. In terms of regulatory frameworks, products already registered for other uses are being extended to cover specialty minor crops, joint trials are permitted to expedite the process, and streamlined review procedures have been introduced. Regarding registration reviews, a grouped catalog system has been adopted, organizing crops and target pest‑disease complexes by category, with centralized reviews conducted primarily at the provincial level. A green channel for pesticide registration reviews has also been established. Driven by national policy guidance and technical support, the number of registered products has grown year after year. As of June 2024, the total number of registered pesticides for specialty minor crops reached 4,774. However, compared with the sheer diversity of these crops, there remains a shortage of effective pest‑control agents. Drawing on practices from developed countries, it is recommended to further encourage the registration of pesticide products for specialty minor crops. Under the current 10‑year protection period for new‑pesticide registration data, for novel compounds protected for 7–8 years, the protection period could be appropriately extended when registering for additional minor‑crop applications—by one to two years for each additional two or three crop categories covered, up to a maximum extension of three to four years—thereby further incentivizing the registration of specialized crop‑specific formulations and better meeting the needs of agricultural production.

05

Prospect

Implementing a system for the protection of pesticide registration‑test data can safeguard the intellectual property and commercial interests of data originators, stimulate investment in innovation, accelerate the development of new pesticides, promote fair competition, and expedite market circulation and product renewal. However, given the varying levels of development across countries and regions, the degree of protection afforded to pesticide registration‑test data also differs. With the implementation of an innovation‑driven strategy, China is transitioning from a major producer of imitated agrochemicals to an innovation‑oriented powerhouse. It is imperative not only to strengthen the supervision and management of pesticides but also to actively encourage and support innovative advances in agrochemical products. To this end, it is essential to provide scientifically sound and equitable protections—through policies, regulations, standards, and evaluation mechanisms—for developers of new pesticide products, technologies, and processes, thereby further ensuring the healthy and sustainable development of China’s agrochemical industry.

Source: Pesticide Science and Management, Issue 12, 2024 Authors: Liu Xue, Wu Lihui, Song Heping