Pharmacovigilance for Herbal Medicines: A Perspective from the Herbal Medicines Industry

Abstract

Herbal medicines are relied upon by a large and increasing percentage of the world’s population for their health needs. Herbal medicines represent a challenging group of products that are regulated and traded through many different channels and in many different forms, making pharmacovigilance a difficult science to apply. This chapter discusses some of the challenges to ensuring a good pharmacovigilance system is actively embraced by industry. It also covers some of the opportunities to industry, end users and other stakeholders that effective pharmacovigilance systems can provide.

The chapter highlights the criticality of improvements in national and global regulations that apply to herbal medicines, and some of the inconsistences and, thus, additional risks to effective pharmacovigilance implementation, through there frequently being confusion about whether a herbal product is in fact in regulatory terms a medicine, a traditional medicine, or a dietary supplement.

As the herbal medicines industry continues to develop new products and extend its global reach, the relative importance of pharmacovigilance will escalate. Governments and companies need to allocate sufficient resources, and regulators and scientists need to partner with industry to pool their respective skillsets and collaborate to further develop appropriate evidence- and risk-based pharmacovigilance expectations and systems for herbal medicines. These should also address the need to better regulate and monitor traditional medicine and complementary medicine practitioner usage of herbal medicines, and to gather and provide global data that will help foster more robust safety evaluations, enhanced market access and further maturation of the industry.