Background

Natural medicines are widely used around the world and are subject to different regulatory systems, usually as either therapeutic goods or foods.

In addition to the factors governed by legislation, they vary considerably depending on a number of factors including the source of raw materials, how they are made and also environmental and ethical considerations.

These guidelines set out existing capabilities in the production of natural medicines, from sourcing of raw materials through to finished products. The more a natural medicine conforms to the best practice in any area, the stronger the potential for an ethically produced and effective medicine.

Natural medicines often contain several potentially active substances in a biologically complex mixture. That is to say, in addition to the major active compounds, there are often other constituents that may modify therapeutic activity. The biological complexity of natural medicines makes quality control more difficult and presents challenges in making each batch of the medicine the same (known as “batch-to batch-consistency”).

Because there are many potential sources of variability, the raw materials and processes involved in producing a natural medicine must be tightly controlled to ensure consistency. The benefit for patients is that products proven in clinical studies can be reproduced with the same properties year after year, ensuring predictable results.

Of course, behind all products from natural sources there are ethical and environmental issues, including the rights of indigenous populations, intellectual property and maintaining the health of the environment, including land, air and water.

The Natural Health Science Foundation believes that provided they meet rigorous and appropriate standards, natural medicines should be an integral part of modern scientific healthcare.