Approved drug

Overview of the process and criteria for drug approval

Approved Drug

An approved drug is a pharmaceutical product that has been authorized for sale and use by a regulatory agency after a thorough evaluation of its safety, efficacy, and quality. The approval process is designed to ensure that medications are safe for consumption and effective for their intended use. In most countries, this process is overseen by a governmental body, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Simple Steps for Using Medications Safely by FDA

Drug Approval Process

The drug approval process typically involves several stages, including preclinical research, clinical trials, and regulatory review.

Preclinical Research

Before a drug can be tested in humans, it must undergo extensive laboratory and animal testing to assess its safety and biological activity. This stage is known as preclinical research. Researchers study the pharmacokinetics and pharmacodynamics of the drug, as well as its potential toxicity.

Clinical Trials

Once preclinical research is completed, the drug enters the clinical trial phase, which is divided into three main phases:

• Phase I: This phase involves a small group of healthy volunteers and focuses on assessing the drug's safety, dosage range, and side effects.
• Phase II: Conducted with a larger group of participants, this phase aims to evaluate the drug's efficacy and further assess its safety.
• Phase III: In this phase, the drug is tested on a large population to confirm its effectiveness, monitor side effects, and compare it to commonly used treatments.

Regulatory Review

After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) or a Biologics License Application (BLA) to the regulatory agency. The application includes all data from the preclinical and clinical studies, as well as information on the drug's manufacturing process and labeling.

The regulatory agency reviews the application to determine whether the drug is safe and effective for its intended use. This review process can take several months to years, depending on the complexity of the drug and the quality of the data submitted.

Criteria for Approval

To be approved, a drug must meet specific criteria set by the regulatory agency. These criteria typically include:

• Demonstrated safety and efficacy through clinical trials.
• High-quality manufacturing standards.
• Accurate and informative labeling.

Post-Approval Monitoring

Once a drug is approved, it is subject to ongoing monitoring to ensure continued safety and efficacy. This is known as pharmacovigilance. The regulatory agency may require additional studies or impose restrictions on the drug's use if new safety concerns arise.

Related Pages

• Drug development
• Clinical trial
• Pharmacovigilance
• Food and Drug Administration
• European Medicines Agency