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GLP (Good Laboratory Practice) was adopted by the OECD Council in 1981. Since then, GLP has played an increasingly vital role in chemical management and provides a solid foundation for global harmonization efforts. China’s government has done lots of work to facilitate the implementation of GLP practices and construction of GLP accredited laboratories. China has translated OECD series on “Principles of Good Laboratory Practice and Compliance Monitoring" and its revisions. GLP inspectors from US, Europe and other OECD member states have also been invited to hold on-site GLP training courses for test facilities staff. In comparison to the strict regulations on animal testing in the EU, China still prioritizes animal testing data as the gold standard in pre-clinical data. This in addition to the Chinese government’s prioritization of GLP capacity building is a key factor in the development of Chemical management in China. Currently, China GLP consists of four GLP (Good Laboratory Practice) systems:
1. SFDA/CFDA GLP
After the 2013, 18th Central Committee of the Communist Party of China (CPC), a number of ministries and governmental departments were reorganized, including SFDA-MOH (State of Food and Drug Administration – Ministry of Health). The former SFDA, now called the CFDA (China Food and Drug Administration) was elevated to a government ministry affording it increased regulatory powers. CFDA is responsible for the management of food, drug cosmetics, medical device, etc. The management scope includes all activities relating to sourcing, manufacturing, distribution, usage, and supervision.
CFDA-GLP focuses primarily on the pharmaceutical sector. The CFDA is the first department to develop GLP in China. The “Good Laboratory Practice (GLP) for Nonclinical Studies” was first-time proposed in 1994 by Ministry of Science and Technology. In 1999, the “Non-clinical Good Laboratory Practice”(trial) was published, which became the main CFDA-GLP regulation after several years of validation by the government; In 2003, the “Non-clinical Good Laboratory Practice”(Formal), together with the “Inspection of Non-Clinical GLP certification”(trial), were issued. Then, China began to formally conduct GLP certification. Later in 2007, SFDA published the “Inspection of Non-Clinical GLP certification” (Formal) as to guide the GLP certification, and indicates the details of requirements. The inspection frequency is every three years.
China’s Drug Administration Law (Drug Law, 2001) mandates that all institutions involved in nonclinical safety evaluation studies and clinical studies are obliged to implement GLP for nonclinical laboratory studies and also implement GCP for clinical trial. This mandatory obligation is obviously a key impetus for testing facilities to become accredited in line with governmental standards.
By 2013, over 60 test facilities have received GLP certification from CFDA. The validity of this certification last three years before reaccreditation is necessary. However, there is a high degree of variability in the respective research capacities of these 60+ test facilities. Financial backing has elevated and afforded a select few a position of global significance while a minority of smaller facilities with inherent capacity and quality issues face serious financial pressures to stay afloat.
2. MOA-GLP
MOA (Ministry of Agriculture) is primarily responsible for GLP capacity building in the area of pesticides. MOA has done a lot of work to develop GLP in this area, and has very close cooperation with US EPA.
In 2006 a series of GLP related regulations and guidance documents were issued such as “Management Procedure for the Monitoring of Good Laboratory Practice for Pesticides (trial)” (MOA Notice No.739) -“Requirements for GLP inspector and Evaluation Form and Criteria for GLP Compliance.”
MOA accredited the first 6 GLP labs in 2010, including the renowned Shenyang Chemical Research Institute. According to the “Data Requirements on Pesticide Registration, China”, five kinds of data are required, i.e. Efficacy, Residue, Five-batch analysis, eco-toxicological data, and toxicological data. All those tests are required to be performed in test facilities designated by MOA, although it is not mandatory to conduct these tests in MOA-GLP labs. Among the test facilities, 126 test facilities are for Field trials, 43 test facilities for hygienic insecticide efficacy, 73 test facilities for residues, 29 test facilities for toxicological test, 13 test facilities for eco-toxicological test, 17 test facilities for five-batch analysis. Some of those test facilities fulfill the MoA GLP principles, although have not obtained MOA-GLP accreditations.
3. MEP-GLP
MEP-GLP is primarily focused on new chemical substances. In 1994, MEP (Ministry of Environmental Protection) published first version Guidelines of chemical testing good laboratory practices-MEP according to OECD GLP principles. In 2003, “Measures on the Environmental Management of New Chemical Substances” (Order No.17) was published to manage new chemicals in China. Tests on new chemicals are then required. In 2004, “The guidelines of chemical testing good laboratory practices” (HJ/T155-2004) was issued to standardize the quality of data and the quality of test laboratories. In 2009, MEP conducted inspection on test facilities for new chemical substance testing, with 7 labs passing the inspections. In 2010 2 more labs were accredited. Of these 9 a single lab withdrew its application and following this in 2012 two more labs were certified. In total there are now ten labs fully accredited by the MEP to comply with China REACH. However these labs are not fully accredited in line with MEP-GLP standards.
In 2010 the MEP started to revise “The guidelines of chemical testing good laboratory practices” (HJ/T155-2004) in accordance with OECD-GLP, and also compiled three other supporting guidelines on MEP-GLP. From June 2012 to September 2012, MEP conducted inspections on the 9 labs mentioned above. The inspection is referred to eco-toxicological test capability as well as GLP principles. In total 8 labs have passed MEP-GLP accreditation, these 8 labs became the first true MEP-GLP labs in 2012.
All of those 8 labs are also accredited by MEP to conduct eco-toxicological tests according to revised “Measures on the Environmental Management of New Chemical Substances” (Dubbed as "China REACH"). So far, ten laboratories in total are accredited to conduct eco-toxicological tests required by China REACH.
4. CNCA-AQSIQ GLP
In 2008, due to the REACH implementation, CNCA (Certification and Accreditation Administration of the People's Republic of China) started OECD accredited GLP capacity in order to comply with the enormous test requirements on chemicals under EU-REACH. In June 2008 the CNCA issued a series of GLP documents in accordance with OECD-GLP (CNCA 2008 Announcement No. 17). Detailed requirements on GLP applications are specified in these documents. CNCA GLP standard bears the closest resemblance to standard OECD GLP.
Seven laboratories have been accredited by CNCA-AQSIQ as of 2013.
As China is not an OECD member, China GLP data doesn’t adhere to OECD GLP Mutual Acceptance of Data (MAD). To overcome this issue, more and more Chinese test facilities are applying for unilateral GLP accreditation from OECD member countries, and some test facilities have been accredited. For example six test facilities have entered in the Belgian GLP Monitoring Program after an on-site inspection, including Covance, Shanghai; FMC, Chemical Technology Co., Ltd.; Shanghai; Laprode (Zhejiang) Analysis Co., Ltd.; Nutrichem Beijing; Pilarquim (Shanghai) Co., Ltd.; Wuxi AppTec Shanghai; Wuxi AppTec Suzhou. Other countries which have accredited Chinese labs include Holland and Germany.
In recent years, the establishment of GLP system in China has progressed significantly, despite that there are still some challenges to be surmounted such as:
Personnel qualification criteria are unfortunately not subject to the same stringent standards as testing facility infrastructural and technological standards. Toxicological experts are very limited resource in China. The Chinese Society of Toxicology initiated certificate examination in2009 for toxicologists (CTCST or Certified Toxicologist of Chinese Society of Toxicology)
Lack of Computerized data collection system although some GLP test facilities are implementing LIMS (Laboratory information management system).
Animal quality is not very good, lack of Historic/background information on animals
Equipment management and maintenance systems are not adequate in most labs.
Analytical and bioanalytical capacities need to be improved
New technology/methodology need to be adopted.
Compliance of laboratory suppliers with GLP principles need to be prioritized. There are no official requirements on the management of suppliers.
Animal welfare: AAALAC is increasingly playing an important role in animal testing in China. A total of 6 SFDA GLP compliance labs are AAALAC accredited. However, animal welfare is still inadequate in comparison to more developed systems.
While China is a hugely important player in the global chemical market, it has still considerable progress to make in developing its laboratory infrastructure and the quality of these laboratories. The priority is the establishment of laboratories subject to the same oversight and rigorous standards as laid down in OECD GLP standards. With global Chemical management subject to increasing legislative reform and increasing regulatory interventions, China will use every tool at its disposal to maintain its competitive edge.
