On 30 Jun. 2017, China MoA invited public consultation on “Data Requirements for Pesticide Registration” and 5 other supporting rules for new pesticide regulation. The guideline for the determination of technical equivalence was included in the Annex 4 of the “Data Requirements for Pesticide Registration”. Compared with the currently enforceable requirements, “MoA Order 10-Data Requirement on Pesticide regulation (2008)”, the new requirements clearly specify the applicable scope and some of the new criteria have become as stringent as that of developed countries. All of this is expected to reduce new registration of generic pesticide 30% by 2020. A comparative analysis on the scope and criteria is provided to interpret the impacts on me-too pesticide registration. TECHNICAL GRADE ACTIVE INGREDIENT(TGAI) Applicable Scope Currently, technical equivalence determination is mainly utilized for me-too registration, which enjoys considerable data waive and fast-track preference. In the draft, 3 more conditions were added. Conditions subject to mandatory determination: Apply for TGAI(technical grade active ingredient)registration under equivalent product(me-too) category; A TGAI registrant alters the production process/production site; If a formulation alters the source of TGAI, the equivalence determination between new sourced TGAI and the original TGAI should be conducted; If an applicant is seeking registration under equivalent formulation, the equivalence between the TGAIs of the proposed formulation and referenced formulation should prior determined; Tiers and Technical Criteria

On 30 Jun 2017, China MoA issued 6 draft supporting documents related to China’s new pesticide regulation, which includes the most important technical guidance for pesticide registration, “Data Requirement for Pesticide Registration”. MoA will solicit public opinion until 30 Jul 2017. The full content of the 6 drafts are available at MoA’s website:

On 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 improvent on 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.

On 21 Jun 2017, China MoA issued Ministerial Orders 3, 4, 5, 6, 7 of 2017, promulgating 5 administrative measures for new pesticide regulation. The draft measures were initially circulated for inter-ministerial consultation in early April and the second drafts were subject to public comment and feedback in late April and finally approved under MoA’s executive meeting on 1 Jun 2017.

By May 2017, 36,433 pesticides using 672 active ingredients have been registered with China ICAMA, of which 35,408 are registered by 2,116 Chinese domestic companies, 308 are registered by 20 US companies, 189 are registered by 8 German companies, 179 are registered by 24 Japanese company, 106 are registered by 2 Swiss companies and other 243 are registered by 53 overseas companies from India, Australia, Israel, Singapore, UK, Korea and Italy, etc. Technical Grade Products 4,269 of the registrations are for manufacturing use, consisting of 3,993 TCs(technical), 230 TKs (technical material),38 TKLs (technical material in liquid) 8 TKPs (technical material powder) and 1 TFs(another form of technical material powder). 8 of the products are mixtures of complex compounds such as enadenines, brassinolides, and sodium/potassium nitrophenolates. With the patent expiry in 2011, azoxystrobin became the top registered TC in the last five years and the registration of pyraclostrobin is growing after it’s patent expiry in 2015. The development of more herbicide-resistant GMOs is driving more producers to register traditional generics such as 2,4-D and dicamba. large Fig.1-Top 20 Most Registered Technical Grade Active Ingredients (TGAI) Since 2012 Product Category and Formulation Type Around 38% of the formulations are insecticides, followed by fungicides 26%, herbicides 23% and health pesticides 7%. E Although market share of ECs has decreased each year since China MIIT begun restricting the production approval in 2009, it represents the highest proportion among all formulation types. The reason for the record high number of approved products in 2009 was the promulgation of “Data Requirement on Pesticide Registration” in 2008. Most companies had started the efficacy, residual and toxicological tests in 2007 and the applications were finally approved in 2009. It is estimated that the number of registration will be redu

On 9 May 2017, Chinese National Health and Family Planning Commission(NHFPC) issued a circular regarding textual amendment on the “Measures for the Hygienic Administrative License of New Disinfectant and Water Related Products”. These amendments were made under the reform of administrative approval system and function transferring from Health Supervision Center(HSC) to the Chinese Center for Disease Control and Prevention(CDC).

On 26 May 2017, China ICAMA announced the suspension of acceptance and approval of pesticide field trial and temporary registration starting from 1 June 2017. Companies engaged in pesticide production, marketing and testing institutions may continue their operation activities prior to the effectiveness of supporting rules for the new pesticide regulation

On 12 May 2017, China MoA invited departmental consultation to ban/restrict the agricultural uses of 5 active ingredients including endosulfan, bromnomenthane, acephate, carbosulfan and dimethoate.

According to the China Crop Protection Industry Association, the top 100 Chinese agrochemical companies achieved total sales of 109.87 billon CNY in 2016, representing a contrarian increase of 5.81% on previous year of 103.84. The qualifying criterion for the ranking list declined by 5% to a minimum of 303 million CNY.

The Brazilian MAPA has drafted a list of products which will be subject to priority review in 2017, which was discussed with IBAMA and ANVISA during the 2nd regular meeting of CTA (Technical Advisory Committee of Pesticide). 53 pesticides were included into the list, of which 26 are insecticides, 20 are herbicides and 7 are fungicides.