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Good Lab Practice (GLP) was first drawn up as an internationally agreed guideline for the non-clinical testing of pharmaceuticals and chemicals. Companies preparing Risk Assessment report while complying with China Chemical Regulations are more often than not, faced with the option to choose between data generated with the non-GLP and GLP laboratories. Meanwhile, the promotion of GLP in China Regulatory compliance sector has been observed through its incorporation into some of the key Regulation recently released, such as "Measures on the Environmental Management of New Chemical Substances". Interviewed by Chemical Watch, experts from REACH24H would like to share their comments on the related issue.
Q1. How has GLP been benefitting safety of chemicals in China? Or, looking to the future how is it likely to benefit chemicals safety in China?
Good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical safety tests.
GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments and making classification and labeling. Thus, we can get a reliable risk/safety assessment and C&L result, which is the base for the industry or authority to enforce effective risk management measures and communicate reliable information (such as RMM and C&L) along the supply chain and finally to achieve the ultimate chemical safety goal in China.
GLP is not only a lab qualification standard, but also a management principle and system. It requires the investment in both equipment and the training for lab staff to improve both the hardware and the people working in the laboratories. Through the implementation of GLP in China, the validity and accuracy of testing results will be definitely improved, as well as training of experts familiar with GLP, who would propel the GLP standard in China.
As well known, the knowledge and understanding of chemicals in China is behind EU or US, authorities in China are collecting data of various kinds of chemicals by means of notification or registration. Since many requires new testing data, the well established GLP standards in the near future will help us to receive a better recognition of the physico-chemical, toxic and eco-toxic properties of chemicals. Chemicals safety is attainable only based on these findings.
Q2. How has it been benefiting or will benefit the work being done by REACH24H through GLP-compliant laboratories?
REACH24H is a one-stop chemical regulation service provider. Many clients of ours are dealing with global chemical regulations. Testing report from a GLP-compliant laboratory, in most cases, is easier to get mutual acceptance by different authorties. Therefore, getting testing report from GLP-compliant laboratory can help to reduce repeated testing, especially expensive animal testing, and thus lower the regulatory compliance cost of our clients in complying with worldwide chemical regulations. According to the real experience gained through compliance work, REACH24H experts claimed that GLP complaint data helps to increase REACH24H's working efficiency during data quality assessment. While a non-GLP compliant testing report may increase the communication workload between REACH24H and the data holder or our clients. The final result of the risk assessment might as well be influenced due to the possible lower reliability of the non-GLP compliant data.
Q3. How is it helping or will help to raise standards of chemical safety tests and risk assessments in China?
Many national standards or guidance of chemical tests in China are based on OECD testing guidelines. The authorities also tend to push GLP compliant testing data. It is believed that promoting GLP-compliant testing data will improve the data reliability and consequently guarantee more reliable risk assessment results.
Q4. Has GLP been incorporated nt China's chemical safety legislation, such as the "Measures on the Environmental Management of New Chemical Substances"?
Yes, though China GLP is still on the early stage. The earliest GLP concept was adopted in the area of pharmaceuticals by China Ministry of Health (MoH) early in 1990s. However, till now, the different ministries under the State Council have their own GLP standards
A. Ministry of Environmental Protection
As required by the "Measures on the Environmental Management of New Chemical Substances (known as "China REACH"), eco-toxicological data used in new chemical notification dossier should only be generated from the China local testing laboratories approved by SEPA (State Environmental Protection Agency).
SEPA and the later upgraded MEP approve the related eco-toxicological laboratory by referring to the guidelines of chemical testing good laboratory practices (HJ/T155-2004), which was published by State Environmental Protection Agency (SEPA) in 2004.
SEPA set up this guideline by referring to OECD guidelines for the testing of chemicals and GLP principles. And since then, SEPA started management of eco-toxicological testing laboratory and conducting inspection on eco-toxicological testing Lab.
In Jan. 2012, MEP published management measures of good laboratory practices for chemical testing, based on the requirements of the “Measures on the Environmental Management of New Chemical Substances” (Decree No. 7 of MEP) and Regulations on the Control over Safety of Hazardous Chemicals” (Decree No. 591 of the State Council), which standardized the MEP’s approval procedure of GLP laboratory.
B. SFDA
In 1993, SFDA published the Good Laboratory Practice for Non-clinical Laboratory Studies (trail version). After two revisions in 1994 and 1999, SFDA published the official version of Good Laboratory Practice for Non-clinical Laboratory Studies, as well as Management Measures on Good laboratory Practice for non-clinical laboratory studies, and Inspection Measures on Good laboratory Practice for non-clinical laboratory studies.
In Nov. 2006, SFDA published an official notice on “Promoting implementation of Good Laboratory Practice for Non-clinical Laboratory Studies”, which required that:
Since Jan. 1st, 2007, the data used for non-clinical safety evaluation of Active Pharmaceutical Ingredient (API) and its preparation, biological product and traditional Chinese Medicine Injection should be generated from the GLP laboratory approved by SFDA, otherwise the drug registration application would not be accepted by the authority. In the meanwhile, SFDA published 22 laboratories approved based on GLP for non-clinical laboratory studies.
C. Ministry of Health (MoH)
In 2001, Ministry of Health (MoH) published the “Management Rules on toxicity testing of chemicals”, which provides official management standard of chemical toxicity testing. In 2005, MoH published “Technical Rules on Toxicity Testing of Chemicals”. However, MoH hasn’t set up relative GLP principle and GLP laboratory inspection system.
D. Ministry of Agriculture (MoA)
China has issued and adopted several procedures and standards for GLP of safety assessment of Pesticides, for example:
Standard for Good Laboratory Practices of Pesticide Toxicology Assessment (NY/T718-2003)
Management measure of Good Laboratory Practice of Pesticide examination (Ministry of Pesticide, the 739th Announcement, 2006)
Principles of Good Laboratory Practice for Pesticide Physical-chemical Testing (NY/T 1386—2007)
There is also a research subject of “Pesticide safety assessment GLP system construction” which is part of the National Science and Technology Support program under China’s Eleventh Five-Year Plan. The research subject is now being administered by ICAMA (The Institute for the Control of Agrochemical of the Ministry of Agriculture)
Pesticide GLP in China has made great progress in recent years especially since 2006. MoA has organized a lot of trainings and examinations of Pesticide GLP, which benefit a lot for the Pesticide registration management in China. Since 2008, China has certified several Pesticide GLP Laboratories. China Pesticide GLPs are also planning to join the MAD (Mutual Acceptance of Safety Data) of OECD GLP. The system of Pesticide GLP in China is being in construction and will be improved in the future.
E. Certification and Accreditation Administration (CNCA)
CNCA’s also doing some work regarding GLP. In 2008, CNCA transferred 15 OECD guidelines into Chinese GB standards, and all these standards entered into force in April 1st, 2009. CNCA focus on setting up GLP approval system on industrial chemical.
Q5. Has GLP had to be modified in order to be consistent with Chinese regulations and in what way?
Yes, China authority accepts the international GLP concepts. However, based on the national conditions, some modifications need to be made to be consistent with Chinese regulations. This process will take some time since different ministries in China lack efficient way of communication; for instance, “Regulations on the Safe Management of Hazardous Chemicals” (Decree No. 591) put stricter requirements on the eco-toxicological and toxicological data. Although MEP is leading the GLP inspection for eco-toxicological testing, GLP management of toxicological testing labs for chemical testing is lagging behind the requirement specified by “Regulations on the Safe Management of Hazardous Chemicals” (Decree No. 591). Furthermore, more experienced GLP experts are needed to fulfil the increasing testing requirements of the market.
China authority accepts the international GLP concepts. However, China GLP is on the early stage and is many years later than EU or USA GLP. Based on the Chinese national conditions, some modifications are made in order to be consistent with Chinese regulations, such as the personnel, apparatus etc.
Q6. Does REACH24H believe that improvements could be made to GLP in order to make it more relevant to China's needs and what are these improvements?
Although Chinese chemical market is one of the biggest in the world, the China GLP hasn’t achieved Mutual Acceptance of Data (MAD) from other international/OECD GLP.
What we believe is that China GLP will be developed widely and conform with international GLP eventually in the future. But before that, some improvement for China GLP should be achieved:
For the areas not covered by GLP, e.g. cosmetics, toxicity testing of industrial chemicals, the authorities may need to consider adopting GLP-compliant data. It's better for the authority to have a time schedule and plan to follow.
A specific governmental department, probably the Certification and Accreditation of China (CNCA), should manage and unify the different GLP standards in China (MEP GLP, SFDA GLP, MoA GLP).
China is in lack of GLP experts, especially experienced experts in GLP lab, construction and GLP inspection. More GLP personnel shall be trained.
The improvements are:
Some laws and regulations shall be sound and complete. More laws and regulations shall be operational and objective. However, consciousness was mainly focused on the necessary rule under some regulations. Operational rules shall be drawn up and avoid human subjective errors.
Related GLP personnel shall be trained. The test procedure is as important as the test result. No sufficient details in test reports shall not be thought reliable report, and increased the difficulty to Mutual Acceptance of Data (MAD).
