Most governments around the world impose regulations on pharmaceutical companies, in an effort to protect their public from harmful drug effects. These regulations often prolong the process for bringing new pharmaceuticals to market.

Who regulates the pharmaceutical industry?

The Food and Drug Administration (FDA)
The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases.

What is regulation in pharmaceutical industry?

Pharmaceutical regulations are defined as “the combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information” (Lezotre, 2013; From: Drug Safety in Developing Countries, 2020.

What are the two federal agencies that regulate the pharmaceutical industry?

The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services.

Why is pharmaceutical industry highly regulated?

The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country.

What are illegal substances?

Illicit drugs refer to highly addictive and illegal substances such as heroin, marijuana and meth. While the decision to use one of these drugs for the first time is usually a voluntary one, an unexpected addiction can make the decision to quit later significantly harder.