In my last article, we discussed about the “Public Health” as a single most major responsibility of FDA or any health authority. In the same article, we also saw several mission statements of different regulatory authorities including FDA, Health Canada and MHRA.
For example, FDA’s mission statement reads something like this: “The Food and Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation”
One theme that is common in those mission statements are terms: Quality, Safety and Efficacy. What are they and why are they important?
1. Safety: Regulatory authorities first and foremost look to see if a drug is safe enough in humans or not. The last thing regulatory authorities want is that the drug that causes damage to the health. Regulatory authorities never take risk with human lives. It all comes down to safety first. If drug is not safe enough, it will not be approved. Period.
2. Efficacy: Think efficacy like effect. Regulatory authorities look into whether a drug is showing its intended effect or not. To put it in other words, is it doing what it is supposed to do? Is it treating a disease and making a patient feel better? If a drug is not doing its job properly, it cannot be even called a drug. It cannot be approved.
3. Quality: How well a product is made. Regulatory authorities determine how well a product is made. Every single pill or every ounce in the bottle is supposed to do the same job. If not, how can you trust it? If you cannot trust the quality of product, you cannot approve it.
The safety, efficacy and quality, in technical terms translate to Non-clinical, Clinical and CMC (Chemistry, Manufacturing and Controls). Safety and Efficacy are common themes in both non-clinical and clinical. However, non-clinical is primarily used to evaluate safety even before drug can be tested in humans and hence non-clinical translates to safety.
To FDA or Regulatory Authorities eyes, these three factors (Safety, Efficacy and Quality) need to be strong enough before they can give an approval for a drug to be sold. That is the reason why, through drug development lens, these three pillars (Non-clinical, Clinical and Quality) should form a solid foundation for a drug.
