110 labs applied to the MoARA for accreditation to generate data for new pesticide registration. Only 26 labs have been finally approved based on rigorous assessment involving onsite inspection and assessment of relevant documentation. The low qualification rate relates to lack of technical capacity particurly the inability to fulfill GLP requirements.
On 25 Oct 2018, China MoARA released the 1st batch of testing institutes for pesticide registration experimentation. A total of 26 labs have been approved to conduct studies covering product chemistry, efficacy, toxicology, residue, and environmental impact.
Table-1st Batch of MoARA Designated Testing Institutes for Chinese Pesticide Registration Experimentation
1st Batch of MoARA Designated Testing Institutes for Chinese Pesticide Registration Experimentation
China implemented new rules on lab accreditation since the reform of pesticide regulations in 2017. All existing and new laboratories that want to offer 3rd party testing services to generate the prerequisite data required during new pesticide registration assessment by Chinese authorities need to undergo review of documentation and on-site inspection in accordance with the MoA Announcement 2570, “Rules for the Accreditation on Testing Facilities for Pesticide Registration” and the “Quality Management Practice for the Experimentation of Pesticide Registration”. The latter follows GLP concepts and raise similar requirements on organization and personnel, quality assurance program, documentation, facilities, apparatus, materials and reagents, test system, test items, reference items and samples, SOP, performance of study, reporting of result and archiving.
Up to now, at least 110 labs have submitted applications for accreditation. MoARA has completed the documentary review for most of the applications and conducted on-site inspections on 39 labs, divided into 2 batches. In a semi-official seminar late this August, MoA pointed out the most frequent defects in problems uncovered during documentary review and on-site inspection. MoARA will also offer feedback to the laboratories that fail assessment to facilitate future successful application.
Documentation | On-site |
Absence of organization chart or ambiguities in organization chart; Unqualified personnel responsibility(concurrent job post of QA as SD or PI); Absence of personnel training; Absence of data on personnel, apparatus and instruments; Incompetence in personnel, testing site and equipment; Incompleteness in SOP documentation; Serious inadequacy in representative test report or record of raw data; Absence of representative test report; | Multiple uses of quality inspection instruments; Inadequacy in personnel and performance period of test system and ambiguities personnel responsibilities; Incompleteness in master schedule and study plan; Non-validated or calibrated on data-exporting instruments; Absence of critical SOPs; Unfulfilled internal inspection by QA; Incompleteness in recording; Excess defects in test report and raw data; |
Narrowed Acceptance of Data
China’s new pesticide regulation significantly increased the compliance burden associated with pesticide registration. New requirements include an expanded study scope and increased trial numbers, additional risk assessment reports as well as narrow acceptance of test data. The unilateral acceptance of overseas GLP data has also been terminated. Only data generated by a MoARA-recognized testing facility or overseas labs from a country or organization which have signed MAD (Mutual/ multilateral Acceptance of Data) agreement with China will be accepted during pesticide registration. Repeated animal tests seems to be inevitable as China has not yet signed an agrochemical MAD agreement with any country or organization.
Regulatory studies that must be carried out in China are specifically defined as follows:
Product quality test and validation test of quality inspection method (Applicable to both technical material and formulated products)
Acute toxicity to silkworm (Applicable to both technical materials and formulated products)
Chronic toxicity to bee (Applicable to both technical materials and formulated products but only required for insect growth regulators)
Semi-field test on bee (only required in case of unacceptable risk concluded by preliminary assessment on technical material and study should be conducted using its representative formulated product)
Test of final residue in mulberry leaves (only required for mulberry-use formulated products in at least 3 sites);
All toxicology studies supporting higher-tier health risk assessment (applicable to formulated products);
Field efficacy trial at plot scale (applicable to formulated products);
Field efficacy trial at large-area scale (applicable to formulated products);
Test of residue in crop (applicable to formulated products);
