China to Cut 30% of New Approvals of Me-too Registrations by 2020

By Fang Lin|11 August 2017

The Chinese Ministry of Agriculture has issued new proposals for development of the pesticide industry, including production plant relocation, reduction of generic product and qualification rate, as well as new management policies on pesticide registration, production approval and marketing approval, according to an article from ChemLinked.

A three-elements approval system was established under China’s new pesticide regulation, which took effect on June 1 this year. MoA expects the regulatory reform will help to promote food safety and realize safety and environmental improvements in pesticide production methods.

Phased Goals

Production plant relocation: By the end of 2020, 60% of producers of technical materials will be moved to chemical or industrial parks. The goal is 80% by the end of 2025;
Industrial Adjustment: Merger and acquisition activities among production companies will be encouraged. MoA will strive to eliminate SMEs in the next 3 to 5 years;
Generics reduction: The approval on new registration of generic pesticides will reduced by 30% by 2020 and 50% by 2025. Highly toxic pesticides will be phased out while biopesticides and green pesticides will be prioritized;
Qualification Rate: The eligibility rate should be above 95% for pesticide quality inspection and 96% for residue detection;
Improve Utilization: By 2020, the efficiency of pesticide utilization will achieve 40% and should be equivalent with other developed countries by 2025;
Institutional Perfection: Technological and equipment support will continually be offered to substratum enforcement ranks in the next 3 to 5 years;

Product differentiation and purchasing preferences

Higher efficacy, minimally toxic and low residue pesticides will be prioritized during registration approval. Minor crop pesticides will enjoy data exemptions and expedited administrative processing. Natural enemy pesticides will be exempted from registration requirements. Pesticide with higher risk/potential of risk and insufficient risk mitigation measures will not be approved. For “me-too” generic products, the maximum content eligible for registration of pesticide with the same formulation type and AI (including multiple compound formulations with same AI ratio) has been reduced from 5 to 3. Multiple compound pesticides can combine a maximum of 3 active ingredients. If the formulation/formulation type was optimized based on an existing product, the registration will be prioritized. Periodic review of registered active ingredient will be conducted to speed up the phase-out and substitution of higher risk pesticides.