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How Regulatory Agencies Approve Drugs

The process of drug discovery and development depends on the critical thinking and perseverance of researchers and clinicians who work for years to bring medicines to patients. But the initial idea wouldn’t become a medicine if it weren’t for the role of regulatory agencies, which help to assure the rigor of the data to support the approval of a potential medicine.

The exact regulatory agency that takes part in this process varies by country. Individual countries exert the right to evaluate the quality, safety, and efficacy of new medicines for their citizens. Generally a ministry of health or government department of health oversees this function. This department often includes specific regulatory agencies, such as the FDA, or Food and Drug Administration in the US, responsible for pharmaceutical product oversight. In some global areas, these bodies operate on a regional basis, while in many countries, they operate at a national level.

While there are several differences between countries in the details of regulatory approval, the very basic approach is similar from place to place. In general, after a company or academic sponsor identifies a new compound that they want to advance for further testing, it submits an investigational application to the regulatory agency of the country where it’s seeking approval. The application includes results from initial testing and a plan for further testing. After the regulatory agency deems that research subjects will not be subjected to unreasonable risk, the company can then proceed with the further stages of testing.

There are several stages to the drug approval process that occur after rigorous lab-based testing has first occurred to understand how the drug acts in the body and at what dose further testing should occur. For many types of potential medicines, these stages include initial safety testing, often on animals or through computational methods; testing on healthy humans who don’t have the disease the drug intends to treat (called Phase 1); testing on humans who do have the disease (called Phase 2); and testing on a large patient population to determine the ideal dosage and other factors (called Phase 3). Then the regulatory agency reviews the data following the company’s submission of a marketing authorization application. Information submitted for review is evaluated by multidisciplinary teams composed of physicians, statisticians, chemists, pharmacologists and other scientists.

The overall goal is similar for each of the countries — to evaluate the quality, safety, efficacy, and timely availability of new medicines to their citizens. However, the approaches for exactly how, and at what scale, that review occurs can be very different from country to country.

Approval timelines for potential new medicine globally can vary widely, from less than 1 month to several years. Priority review procedures do not officially exist in most countries globally. However, depending on the product (e.g. new therapy for life-threatening diseases, infectious diseases and cancer) companies can negotiate accelerated review timelines with many regulatory agencies on a case-by-case basis.

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