ABSTRACT
This is more or less related to herbal medicine regulatory affairs. Regulatory affairs (RA), is also known as government affairs. A regulatory affair is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc. Regulatory affairs have a very specific meaning within the healthcare industries including pharmaceuticals, medical devices, biologic and functional foods
The legal situation regarding herbal preparations varies from country to country. In sum, phytomedicines are well-established, whereas in others they are regarded as food and therapeutic claims are not allowed. Developing countries, however, often have a great number of traditionally used herbal medicines and much folk-knowledge about them, but have hardly any legislative criteria to establish these traditionally used herbal medicines as part of the drug legislation.
For the classification of herbal or traditional medicinal products, factors applied in regulatory systems include: description in a pharmacopoeia monograph, prescription status, the claim of a therapeutic effect, scheduled or regulated ingredients or substances, or periods of use. Some countries draw a distinction between “officially approved” products and “officially recognized” products, by which the latter products can be marketed without scientific assessment by the authority.
