The FDA And EMEA Drug Approval Process; Who Gets Cancer Drugs First?

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Main Category: Regulatory Affairs / Drug Approvals
Article Date: 16 Jun 2011 - 10:00 PDT


The US Food and Drug Administration (FDA) is often criticized as inefficient compared to its European counterpart, the European Medicines Evaluation Agency (EMEA). This criticism is especially common in the field of oncology, where severely ill patients have few therapeutic options. However, contrary to popular opinion, the US is actually getting their hands on important treatment medications faster than the European Union.

In a recent study, 23 drugs cancer drugs that were approved in both the U.S. and Europe were tracked and it was found that each debuted in the U.S. first.

Regulators from the two approval agencies don't always agree on a drug however. The researchers note that three cancer drugs were approved in Europe but the FDA has approved 9 that didn't reach Europe. The two agencies have positively have been collaborating on their expectations for clinical trials, to help streamline the development process though.

So what are the steps, more or less to get drugs approved by each agency, or watchdog?

In the United States, the main consumer watchdog in this system is the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER). The center's best-known job is to evaluate new drugs before they can be sold. The center's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. CDER ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.

Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.

Okay, so what about in Europe and the United Kingdom? Well, there are 2 systems within the EMEA that pharmaceutical companies can use to license drugs.

The first is called the 'centralized system'. Any drugs for AIDS, cancer, neuro-degenerative conditions or diabetes have to be licensed this way. The committee that reviews drugs for human use (the CPMP) assess the application, and then recommend whether a drug should have 'marketing authorization' (a license) or not.

The other is the 'decentralized (or mutual recognition) system'. One member state assesses the application (this is the Medicines and Healthcare products Regulatory Agency in the UK, or MHRA). If they recommend that the drug be licensed, the other member states then either agree ('mutually recognize' the drug license) or object. If everyone agrees, the drug is given marketing approval. If someone objects, the CPMP will step in and decide. They then advise the EU Commission whether to license the drug or not.

Once a drug has EU marketing authorization, it is 'licensed', 'registered' or 'approved'. All these terms mean the same thing. This means the company can market the drug in any EU country - but they don't have to. For one reason or another, they may choose to market the drug in some countries but not others.

When a drug has marketing authorization, it is not available straight away. The company first have to apply to market their product in each individual country. In the UK, they will apply to the MHRA. When this last small step is done, the product is 'launched', and doctors can prescribe it.

Sources: Health Affairs, Cancer Research UK and U.S. Food and Drug Administration

Written by Sy Kraft
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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