Non-Approval of Drugs: A Helpful Explainer Before Studying for Regulatory Affairs Certification

regulatory affairs certification

The review of prescription and non-prescription drugs authorized is a long and intricate process, from research and development to clinical trial to ending up on the shelves of local pharmacies. Often, due to a variety of reasons, many drugs do not make it to market, and fail to be approved for public use. Here are some aspects of the regulatory process students interested in regulatory affairs should know.

Therapeutic Value and Product Effectiveness

The effectiveness of a drug allows it to pass clinical trials. Its success relies upon its therapeutic value, or how efficient the drug is at treating the specific ailment, as well as its safety for consumption.

Drugs fail in development because they are either not safe or do not work

Drugs fail in development because they are either not safe or do not work

Therapeutic value can be difficult to determine, as results vary per disease group. If a product makes it to the trial period, its effectiveness can be unpredictable due to a variety of factors, including individual suitability of patients, the ability to recruit new subjects based on their illness, and whether or not the subjects have comorbidity, which means they are affected by two or more chronic diseases.

Ensuring Product Safety, Quality, and Viability in Your Regulatory Affairs Program

Product safety is also a vital aspect of product success. It goes without saying for anyone with a pharmaceutical regulatory affairs diploma that if a product is deemed unsafe and does not meet the standard regulations, it will not be approved. There are many components of product safety, including quality and viability.

Product safety is a key factor when being approved for use

Product safety is a key factor when being approved for use

It is important to remember that regulations are in place primarily to protect the consumer. Unsafe products have the potential to significantly affect the health and wellbeing of the general population, which can have many far-reaching consequences. Due to consumer diversity, it can be very difficult to develop a product that is safe for general use, and this is often the largest hurdle to clear during testing.

Experimental Treatments, Funding, and Demand

Some drugs fail to pass trial because research reflected that the general population was unlikely to use the drug, indicating a lack of demand. If there is no proven consumer demand, then research and development is less likely to be funded through to trials, because sponsors want to be sure the product has economic viability.

As students enrolled in regulatory affairs programs may know, pharmaceutical development is a costly and expensive process, and often a failure to secure proper funding has a clinical trial dead before it truly begins. Sponsors often choose safe, risk-avoidant products to fund because the outcome is more predictable.

To encourage research, many regulatory programs place priority on review for drugs that address life-threatening and serious conditions, such as cancer, AIDS, and Parkinson’s. The immediate demand for a pharmaceutical solution allows for more innovation. However, although innovation may prove to offer viable solutions, it can also fail to match its initial promise, and perform poorly. A potential cure may need more funding and attention than other standard trials, but it might fail to pass the review process because it does not meet expectations.

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