Why are OEL/ADE monographs more expensive for natural health products?

As you can see from the advertised pricing, the price for natural health product (NHP) monographs are more than the price for traditional pharmaceuticals. The reason for this is as follows:

• Unlike traditional pharmaceuticals that are approved by a regulatory authority (FDA, EMA, Health Canada, etc.), natural health products do not have new drug application (NDA) filings, package inserts, or credible databases that summarize pre-clinical and clinical data, etc. This requires that the expert toxicologists locate and review many primary literature and other data sources to identify all the appropriate toxicological information necessary to author a scientifically-justifiable OEL/ADE/PDE report. Many of these literature sources are not free and can cost up to $60/article.
• NHP compounds are complex mixtures that will require the expert toxicologist to review many articles and perform multiple calculations to identify the key indicator compound that will be used as the point-of-departure (PoD).
• The number of studies that must be reported in the monographs can be large; therefore, taking 3-4 times the amount of time to author and QC. Affygility Solutions must be able to recover its cost for authoring.