Chapter 21 - Regulatory Harmonization and Good Quality Practices for the Development of Herbal Medicine

Abstract

Regulatory harmonization in herbal drugs development is inevitable from both an economic and medical standpoint. The free movement of safe and effective herbals medicines throughout the world may be ensured by practicing good harvesting practices, good agricultural practices, good manufacturing practices, good agricultural, and collection practices for developing herbal drugs from farm to market. Harmonization of herbal health claims is achievable only for those herbal medicines having sufficient scientific data to support the claims of safety and therapeutic efficacy. Good Clinical trial practice will be required in the form of well-designed, controlled, clinical trials with quality reporting. Good laboratory practice in scientific research may help in standardized quality reporting globally. Intellectual property rights and international regulatory status of herbal medicines are equally important for the global promotion and development of standardized herbal medicine. This chapter addresses all these important issues related to the regulatory harmonization and good practices related to promotion and development herbal medicine globally.