The process of testing, developing and marketing of medicines has to regulated to protect the interests of the public. Major regulatory bodies include the Food & Drug Administration (FDA) in the US and the European Medicines Agency (EMA) in Europe. These bodies have various functions.
Licensing new medicines. New drugs are given a ‘market authorisation’ based on the evidence of quality, safety and efficacy presented by the manufacturer. The regulator will not only approve the drug but will also take great care to ensure that the accompanying information reflects the evidence that has been presented. This document is known as the Summary of Product Characteristics (SPC) or ‘label’ provides detailed information about indications, dosage, adverse effects, warnings, monitoring etc.
Drug regulatory authorities often have other important functions including:
- Pharmacovigilance .
- Regulating clinical trials.
- Regulating herbal and homeopathic medicines.
- Inspecting and maintaining standards of drug development and manufacture.