1, approved by the Ministry of Health in 1996, and Cambodia’s medicinal plants, Vol.2, approved in 1997, and in Your medicines in your garden, which was approved in 2000. 3 of Cambodia’s medicinal plants is currently in development.The National Center of Traditional Medicine has established a committee with 11 members (Committee for Researching Traditional Medicine), and submitted the proposal (No.
Safety requirements for herbal medicines include the same requirements as for conventional pharmaceuticals, as well as special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products.
Compliance with these requirements is ensured through “compositional guidelines” for approved complementary medicine substances that describe the identity tests and limits for contaminants and residues, although these are not legally binding on manufacturers.
In place of a national pharmacopoeia, the British pharmacopoeia is used, and is considered legally binding in those cases when a herbal medicine is listed in the pharmacopoeia.
A number of monographs are used in place of national ones; however, they are not considered legally binding.
Regulatory requirements for herbal medicines include adherence to information in pharmacopoeias and monographs and the same GMP rules as those used for conventional pharmaceuticals.
Implementation of these requirements is ensured through GMP licensing for finished goods manufacturers.
No national research institutes have yet been established for TM, CAM or herbal medicines.
In 1989, Australia began regulating herbal medicines by means of the Therapeutic Goods Act, which contains partly the same regulations as those issued for conventional medicines.
The countries of the region demonstrate a high level of political commitment to TM/CAM policy and research, which is similar to the total survey response percentages.
Almost one third of all the countries responding to the survey have each of the different forms of policy and regulation for TM/CAM and herbal medicines.
The national programme and national office on TM/CAM, the Office of Complementary Medicines, was established in 1999; the office is administered by the Ministry of Health.