Good Laboratory Practice (GLP) status of Asian countries and its implementation in non-clinical safety studies in pharmaceutical drug development.
Non-clinical animal studies to assess the safety of compounds under development have to comply with Good Laboratory Practice (GLP). The Organization for Economic Co-operation and Development (OECD) has established the Mutual Acceptance of Data (MAD) system in OECD member countries for the mutual acceptance of non-clinical safety study data. Since 1997 non-OECD-member countries have also been able to participate in the MAD system, if the country meets the level of standardized compliance with OECD GLP. Thus, several Asian non-OECD countries are trying to develop their GLP standards in order to become official members of the MAD system. Pharmaceutical companies face significant expense in the drug-development process, including the cost of non-clinical safety studies; in response, companies in Asian countries are seeking to establish GLP facilities to provide cost-effective services for drug development. To assess the quality and cost of GLP performance in Asian countries, in this study we approached GLP facilities in a number of Asian countries to obtain price and quality information on a 'virtual compound' to be assessed in non-clinical safety studies. Also, the development status of GLP in Asian countries in terms of policy and infrastructure was analyzed. We found that, among Asian countries, India and Singapore may be candidates for participation in te MAD system in terms of their compliance with GLP, language, and costs. These findings will be beneficial to pharmaceutical companies planning GLP studies in Asian countries.
Sasaki
Madoka
M
Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Sakyo-ku, Kyoto, Japan.
Hinotsu
Shiro
S
Kawakami
Koji
K
D002681:China; D019411:Clinical Laboratory Techniques / Q000191:economics / Q000592:standards; D003362:Cost-Benefit Analysis; D004353:Drug Evaluation, Preclinical / Q000191:economics / Q000379:methods / Q000592:standards*; D004345:Drug Industry / Q000191:economics / Q000379:methods / Q000592:standards*; D016903:Drug Monitoring / Q000379:methods / Q000592:standards; D007194:India; D007723:Korea; D012846:Singapore; D018675:Toxicity Tests / Q000191:economics / Q000592:standards*