Abstract

Good Laboratory Practice(GLP) is becoming more and more important in the research and development of Oriental Pharmacy(OP) and its globalization. If a OP product is to be registered as Over-the-Counter(OTC) drug and enter international markets, the safety and efficacy studies conducted according to GLP requirements is necessary. The article introduces the content of GLP requirements and the recent development of GLP. The safety and efficacy assessment for OP or herbal medicines under GLP are also covered. This paper also briefly describes the areas that should be covered by GLP regulation and the areas that do not need to follow GLP requirements.