China’s ICAMA Reveals Key Changes in Revised Draft of Measures on Pesticide Registration Management

On May 12, 2023, the Institute for the Control of Agrochemicals, Ministry of Agriculture of China (ICAMA) published the draft Measures on the Management of Pesticide Registration for public hearing. This article is to extract several key changes that may attract attention within the draft.

Possible Acceptance of Overseas OECD-GLP Data Reports in Applications

1. Registration test reports must be conducted in China-GLP-certified labs or overseas labs recognized under a mutual agreement between the respective governments. However, efficacy trials, residual tests, and environmental fate tests that are closely related to Chinese environmental conditions should be conducted in China.
2. Overseas test reports may be accepted to expedite the registration of a new pesticide with novel active ingredients based on local conditions, as determined by the Ministry of Agriculture (MoA) and expert committee.
3. Applicants must submit Chinese translations of overseas test reports.

Key Points in Dossier Submission and Evaluation

1. Applicants cannot submit supplemental data after submitting a registration application unless the registration committee requires it.
2. If the registration was declined, the applicants may first resubmit supplement data only, according to MoA’s registration review within two years. However, for safety issues related to humans and animals, environmental fate, and quality of agricultural products, applicants must resubmit a full package of the registration application dossier.
3. In the second resubmission, applicants should provide a full package of the registration application dossier.
4. Registration test data should be regenerated if the registration application is declined three times by the MoA.

Key Points of Data Authorization and Waiver

1. Registrants who already hold certificates can authorize the full package registration data to others to obtain a copy of the registration.
2. Chronic toxicity data, as well as impurity and metabolite toxicity data, can be authorized to other applicants alone if the pesticide registration tests have been conducted three or more times in different labs. The authorization fee should be less than 70% of the overall test fee.
3. Toxicity data for the metabolite can be waived after registration committee approval, once pesticide tests have been conducted three or more times in different labs.

Me-Too Registration Requirements

Approval of target TC and formulation registrations is required for me-too TC and formulation registrations, as well as similar formulation registrations.

Improved Management of Manufacturing Licenses for Chinese Companies

1. Chinese applicants that apply for technical registration must obtain a pesticide manufacturing license before their application unless they register a new active substance pesticide.
2. Chinese applicants apply formulation registration must provide a supply source TC registration certificate and manufacturing license along with their application.
3. Chinese pesticide registration certificate holders can’t get registration renewals without a manufacturing license.

Management of Consulting Company

Chinese authorities prohibit registration consulting companies from investing in China-GLP labs.