Various parameters/guidelines regulating the safety and efficacy of herbal
pharmaceuticals, as well as their manufacturing and distribution, have been strongly
implemented by regulatory bodies. To understand the pre-marketing requirements, the
legislative status of herbal drugs/products was analyzed in this chapter for various
countries in Southeast Asia, Africa, America, Europe, and Austria. Apart from the
challenges of herb availability and conservation, it has been shown that there is a lack
of harmony in the regulatory requirements for herbal products across the world. A
critical evaluation was performed in order to detect the obstacles in the harmonization
of herbal products. The worldwide trade and development of herbal products are being
hampered by these issues. The herbal drug industry is inadequately regulated in most
countries, and herbal medicines are often neither registered nor controlled. Quality
compliance and assurance of the safety and efficacy of the marketed herbal drugs are
major issues faced by developing as well as developed countries across the globe. The
problem arises when herbal medication is utilized without legitimate permission, or in
huge dosages, or in combination with other drugs for a longer period, or without
discussion with a doctor, and produced properly. Taking these factors into account, the
World Health Organization's International Drug Monitoring Program (WHO) has
published standards for herbal assessment and quality control testing in order to
improve the safety and efficacy of herbal-based therapeutics. This chapter covers the
importance of regulatory affairs to be used in the processing of herbs and herbal
products, and a comparative study of regulatory situations in different countries
Keywords: Compliance, Harmonization, Legislative, Legitimate, Quality control, Regulatory affairs, Therapeutics.
