Harmonisation
Article 65/65 of the Treaty of Rome directed that the registration of herbal medicines be harmonised throughout the European Community.
Even now, this has not been accomplished because each member state has been allowed to interpret the rules and register the medicines through their own National Health Ministries.
The formation of the European Medicines Evaluation Agency (EMEA) may now make the harmonisation possible within the next five years.
As with all pharmaceuticals the registration of herbal medicines involves the demonstration of Quality, Safety and Efficacy.
Quality
Whilst Safety and Efficacy are relatively easy to prove through in-
Variations in starting materials can be caused by many factors including but not limited to:
Selection of specie and variety
Location of growth
Altitude of growth
Climate of growth
Soil conditions and type
For these reasons, Essential Nutrition Ltd adopted a policy, together with an agronomy company, of identifying the correct specie and variety, and growing in crop trials to find the optimum of the above factors. These then become voucher specimens from which all future crops will be grown.
Other factors such as:
Pesticide levels
Time of harvest
Adulterants
Heavy metals
Drying
Storage
will be addressed by contracting the agronomy company to grow the crop on our behalf, and to document the detail of each factor providing a certificate of conformity at the end.
Registration
Although addressing the former problems will not provide a raw material without variation it will give us assurance that the target fraction is available and will enable us to meet the botanical requirements of registration.
A further consideration of registration is the requirement to assay a product. This is achieved in many cases by extracting a herb to produce a fraction which can be quantified. This work may also lead to a method which can be patented in addition to providing a material which can readily be assayed.
To obtain a fraction implies knowledge of the activity of the whole plant. Clues
to this activity can be obtained from an ethnopharmacology study, via databases such
as "NAPRALERT", and other journals. Activity can be validated in-
Intellectual Property Rights
Because of the tendancy of current herbal medicines to require large numbers of unit doses to obtain therapuetic levels of a drug, Essential Nutrition Ltd has developed a policy of producing concentrated fractions which can provide the daily dose in a small tablet. This can improve dose compliance and provide additional Intellectual Property Rights.
The concentrated fraction also permits slow release technology, enteric coating, or some other dosage form such as patches, to provide additional Intellectual Property Rights.
Carbon Dioxide
Stability studies to I.C.H guidelines also provide data about the stability of the fraction. During the extractions of fractions, consideration must be given to residual solvent levels in the product and environmental rules on discharges of solvent residues, and for this reason Essential Nutrition Ltd has chosen to work with liquid and supercritical carbon dioxide.
