What is a drug?

That sounds like a simple question, but can actually be difficult to answer.

As part of a market entry strategy or overview of the commercial landscape, we often have to look at the regulatory framework in a country.

For many products from pharma or biotech it’s obvious that something is a drug,  medicinal product, biological product or device. However, for those involving nanotechnology, tissue engineering, biologics,  or combinations of drugs/devices, it can be less clear.

Understanding how a product is classified from a regulatory perspective, something that may differ between countries, will impact a path to market strategy.

In the United States, under the Federal, Food Drug and Cosmetic Act (21 U.S.C. 321), the term “drug” includes:

“articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”

Dietary supplements such as vitamins are usually not considered to be drugs.

However, new research is coming out that shows vitamins may be more active than we may have previously thought.

Pieter Droppert on Biotech Strategy Blog has commented on research that showed giving vitamin E supplements to healthy men led to a 17% increased risk of prostate cancer.

In pancreatic cancer, researchers showed that Vitamin E may improve the effectiveness of gemcitabine.

In future it is possible that the regulatory classification for vitamins may change if they end up being given as active compounds for the treatment of a disease.  What is a drug remains a simple question, but one that is not always easy to answer.

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