China to Reduce 30% New Approval of Me-too Registration by 2020

China’s Ministry of Agriculture has outlined plans to implement production plant relocations, reduction of generic product registration and qualification rate, as well as new management policies on pesticide registration, production approval and marketing approval. MoA expects regulatory reform would help to promote food safety and improvements in pesticide production.

China to Reduce 30% Generic Pesticide New Registration by 2020On 25 Jun 2017, China MoA issued an opinion regarding a developmental program for the pesticide industry. The document proposes production plant relocation, reduction of generic product and qualification rate, as well as new management policies on pesticide registration, production approval and marketing approval. A 3-elements approval system was established under China’s new pesticide regulation, which took effect on 1 June this year. MoA expects the regulatory reform would 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 & 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 pesticide 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.

Future Legislative Plan

  • Catalogue of Restricted Pesticides;
  • Maximum Residue Limits for Pesticides in Imported Agricultural Products;

Reference Link

MoA's News Release(in Chinese)

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