Regulation on herbal products
2000
Ramli A G, Kementerian Kesihatan Malaysia, Biro Pengawalan Farmaseutikal Kebangsaan.
There has been huge growth in the use of herbs worldwide. World Health Organisation estimated that 80% of the world population used herbs for their primary health needs. In Malaysia, herbal medicine is one of the components of . traditional medicines and this is regulated under the Control of Drugs and Cosmetic Regulation 1984 since 1992. Registr~tion was based on quality and safety profile of the product. 1996 marked a new era in the Malaysian herbal industry with the licensing of the Good Manufacturing Practices (GMP) compliant factories to ascertain the quality of herbal medicine. It is predicted that the use and popularity of herbal medicine is escalating. This has presented many challenges to the regulatory authorities worldwide to ensure quality, safety and efficacy of herbal medicines for widespread consumer use. Balancing the regulation of herbal medicine requires careful evaluation of the existing evidence, collaborative and co-operati ve relationships between government, industry, practitioners, scientists and consumers. The regulatory system must continue to ensure the consumers the highest possible level of confidence in the overall quality, safety and efficacy of herbal medicine.
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