2016-08-30
11 New Active Ingredients to be Fully Approved in China
On 25 Aug 2016, China MoA released the meeting-minutes of the 19th session of the 8 National Expert Committee of Pesticide Registration, which was held on 26 Jul in Beijing. A total of 43 pesticides using 21 new active ingredients were reviewed for full registration. 20 pesticides using 11 new active ingredients were approved, of which 3 were submitted by MNCs: halauxifen-methyl herbicide by Dow Agroscience, fluoxastrobin fungicide and amicarbazone herbicide by Arysta.
Overview of Chinese Pesticide Market in 2015
A double digit decrease in exportation figures and a muted performance from China’s domestic market have reduced the profits of Chinese agrochemical producers;
The full chain agronomic services offered by multinationals and domestic distributors have forced the traditional middleman out of the supply chain equation;
Rising costs of compliance with China’s EHS regulations has transmitted to the agrochemical industry;
Domestic products saw reduced or flat prices while imported products achieved 10 to 20 percentage growth;
In 2015, China produced 1.33 million tons of pesticide active ingredients, down from 1.49 tons in 2014. Exportation fell by more than 10% in both volume and value terms. Influenced by complex factors including weather, regulatory policies and changing distribution channels, the domestic usage was slightly lower than expectation at 0.3 million tons, causing Chinese producers to feel the pinch of higher fuel and labor costs.
Production and International Trade
The largest percentage reduction occurred in herbicide and insecticide categories, decreasing the total production by about 11.7% compared to 2014, representing a 4-year low.
Table1- Chinese Pesticide Production in 2015 (a.i., 000 tons)
2016-07-07
China ICAMA Hosts Panel Discussion on Efficacy Data Requirement for Pesticide Registration
Four major aspects associated with efficacy data requirements have been clearly defined in the new regulation: comparative analysis with existing pesticide, resistance management, efficacy validation test by subsequent applicant and necessary data to justify the scientificness of multiple compound pesticides.
2016-07-07
China ICAMA Issues Interim Guideline on Pesticide Registration Efficacy Test Trial Location
On 28 Jun 2016, China ICAMA issued the “Interim Guideline on the Field efficacy Trial Sites of Pesticide Registration”, which includes the requirements for trial location of 20 major crops and over 140 pests and diseases and will take effect on 1 Aug 2016.
2016-06-12
China ICAMA Issues Interim Guideline on Trial Site Selection of Pesticide Residue Study
On 6 Jun 2016, China ICAMA issued an interim guideline, “Guideline on Crop/Area Distribution for the Residue Study of Pesticide Registration”, which will take effect on 1 Aug 2016.
China Pesticide Registration Hampered by Major Deficiency in Field Trial Application and Efficacy Study
As a preliminary and essential step in registering a pesticide finished product in China, the applicant should obtain the field trial approval from the MoA. Efficacy and residue studies can be then performed in accordance with full registration requirements. The MoA Order 10 “Data Requirement on Pesticide Registration” was issued in 2008 to specify the requirement for each category of pesticide. The success rate of field trial application decreased from over 90% in 2007 to less than 70% in 2009. ICAMA has summarized the most common problem during field trail application and efficacy study to help applicants better understands data requirements.
Field Trial Application
General Requirement
Applicants are required to fill the “Application form of Field Trial for Pesticide Registration” including the following details:
Data Requirement for Field Trial Application
New Pesticide
New Formulation
Me-too Product
Novelty
containing on AI(active ingredient )which was not yet registered in China or the active ingredient was within the 6 years’ data protection period
containing on AI which was already registered in China, but differ from previously registered product in formulation type, AI composition (AI of single compound formulation or the combination and ratio of the AIs in multiple compound formulation) or content level
Formulation , AI combination/ratio and content level were identical to the product previously registered in China
Product Chemistry
Summary on the active ingredient, technical material and formulation;
Summary on the active ingredient and formulation
If the product contains active ingredient which was previously registered but under data protection in China, the applicant should provide the infor
2016-04-25
China ICAMA Consults on Batch 4 Pesticide Registration to be Approved in 2016
On 22 April 2016,China ICAMA issued the 4th batch of pesticide product to be approved in 2016 for public consultation until 28 April 2016.
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