Progress and Status Quo of China’s Pesticide GLP System

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Progress and Status Quo of China’s Pesticide GLP SystemThe introduction of GLP (Good Laboratory Practice) to China’s pesticide registration dates back to the 1980s and toxicological laboratories began to follow the principles. Between 1982 and 1986, a safety evaluation center funded by the United Nations Industrial Development Organization (UNIDO) was established and a series of GLP documents in the form of agricultural standards, targeting specific areas such as residue test, physical and chemical analysis, and environmental safety evaluation. In late 2003, MoA(now known as MoARA) issued the ministerial regulation, “MoA Announcement 739-Measures for the GLP Compliant Accreditation of Pesticide Laboratories’”, marked MoA a GLP monitoring authority in pesticide area and 29 pesticide laboratories were accredited between 2010 and 206. But at the same time, MoA also accepted test data from GLP/GEP institutes accredited by CNAS, CMA CAL and other authorities can also be allowed for pesticide registration until the pesticide regulatory reform since 2017.

China has been an active participant in global exchange and cooperation. Since 2005, many government officers have participated in the OECD GLP working group meetings and inspector training course. China and the US signed a cooperative agreement on the “sustainable GLP compliance monitoring program” in 2005, which has been renewed biannually until 2017. China also participated in various accreditation events initiated by monitoring authorities from OECD members such as Belgium, Germany, Netherlands, and Poland, etc. By 2020, 16 out 27 Chinese testing facilities accredited by OECD members are pesticide laboratories.

With the promulgation of new pesticide regulation in 2017, GLP accreditation became a requisite for the registration process: only data from MoA-recognized testing facilities or overseas labs from a country or organization which have signed MAD (Mutual/ multilateral Acceptance of Data) agreement with China will be accepted for registration.

In September 2017, China issued the MoARA announcement 2570, "Rules for the Accreditation on Testing Facilities for Pesticide Registration & Good Laboratory Practice for the Experimentation of Pesticide Registration". The Announcement was made were made under the “Regulation on the Administration of Pesticides” and the “Administrative Measures for the Experimentation of Pesticide Registration” to standardize the accreditation and management on laboratories engaged in the regulatory study of pesticide. The former specifies the study scope, procedures, and technical requirements for the accreditation, while the latter specifies the principles to be followed: the organization and personnel, testing facilities, instruments, materials and reagents, test systems, test items, reference items and samples, SOPs, performance and reporting of study.

In 2018, MoARA issued the “Inspector Manual of the On-site inspection for the Accreditation of Testing Institutes for Pesticide Registration” and additional 2 documents regarding data review and surveillance are being developed. 

Since China adopted the mandatory accreditation on March 1, 2018, 414 testing institutes have filled the application. After the documentary review on 401 institutes and on-site inspection of 252 institutes, MoARA approved 177 institutes for pesticide registration, covering 5 major areas: products chemistry (38), residue (63), toxicology(18), environmental impacts(28) and efficacy(93).

 

 

Similarities and Difference between China GLP and OECD GLP

 

China GLP(MoARA)

OECD GLP

Similarity

elements: organization and personnel, quality assurance, test facilities, instruments, materials and reagents, test system, controls of test items and samples, SOP, performance, reporting of study and archives;

Process: data review, onsite inspection, rectification review, comprehensive evaluation, and review;

Principles: China GLP complies with the OECD GLP principles

Accreditation validity

5 years

2-3 years

Bear cost

Government financed

Mainly paid by applicants

Study

scope

  1. Product chemistry;
  2. Efficacy;
  3. Residue;
  4. Toxicology;

Environmental Impacts

  1. Physical and chemical property;
  2. Toxicology;
  3. Mutagenesis;
  4. Toxicity to Aquatic and terrestrial organisms;
  5. Behavior in water, soil and air; bioaccumulation;
  6. Residue;
  7. Analytical and clinical chemistry;
  8. Impacts on mesocosm and natural ecosystem

Others;

 

China published national standards and agricultural standards for the testing of product chemistry, residue, toxicology, and environmental impacts, which are largely transformed or equivalent to those adopted in the EU, US and OECD methods:

Number of OECD Methods Adopted in China

Area

China method

OECD method

Adopted by China

Product Chemistry

38

23

16

Health impact

39

79

35

Environmental impact

27

39

23

Environmental behavior

12

22

10

Residue and metabolism

16

9

6

Total

122(excluding biopesticides and full component analysis

172

90

 

If there is no available OECD method, the US, EU and CIPAC methods are important supplements. It should be noted that there are some differences between the methods in China and OECD methods, mainly because of the utilization of earlier versions.  Besides, China seldom adopted In Vitro methods whereas this area is roaring in the developed economy as 50% of the new methods developed by OECD are in vitro.

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