An experimental drug is a medicinal product (a drug or vaccine) that has not yet received approval from governmental regulatory authorities for routine use in human or veterinary medicine. A medicinal product may be approved for use in one disease or condition but still be considered experimental for other diseases or conditions.
In the United States, the body responsible for approval is the U.S. Food and Drug Administration (FDA), which must grant the substance Investigational New Drug (IND) status before it can be tested in human clinical trials. IND status requires the drug's sponsor to submit an IND application that includes data from laboratory and animal testing for safety and efficacy. A drug that is made from a living organism or its products undergoes the same approval process but is called a biologics license application (BLA). Biological drugs include antibodies, interleukins, and vaccines.
In Canada, a Clinical Trial Application (CTA) must be filed with the Health Products and Food Branch (HPFB) of Health Canada before starting a clinical trial. If the clinical trial results show that therapeutic effect of the drug outweighs negative side effects then the sponsor cab then to file a New Drug Submission.
Clinical trials in the European Union (EU) are regulated by the European Medicines Agency (EMA). Beginning in 2019 all applications for clinical trials must use a centralize EU portal and database. All clinical trial results will available to the public with the summary written in layperson's language.
- "How Drugs are Developed and Approved". U.S. Food and Drug Administration. Retrieved July 27, 2018.
- "How Drugs are Reviewed in Canada". Government of Canada. Retrieved July 27, 2018.
- "European Medicines Agency - Clinical Trials Regulation". European Medicines Agency. Retrieved July 30, 2018.