By Mary Gabb

Health Outcomes Communicator is starting a regular series describing the major drug approval agencies and healthcare systems in countries across the world. In this first article, we’ll start with two of the largest drug approval agencies – the Food and Drug Administration in the United States (US FDA) and the European Medicines Evaluation Agency (EMEA).

US FDA

The main role of the US FDA is ensuring the safety and efficacy of human and veterinary drugs and medical devices, although it also regulates the safety and accurate representation to the public of foods, cosmetics, and electronic products that emit radiation.

The FDA’s role in biological products includes product and manufacturing establishment licensing, safety of the nation’s blood supply, and research to establish product standards and develop improved testing methods. With regard to drugs, its oversight includes product approvals, over-the-counter and prescription drug labelling, and drug manufacturing standards, through the Center for Drug Evaluation and Research (CDER).

It is also involved in post-drug approval processes, such as post-marketing surveillance, prescription drug advertising and promotional labelling, pharmaceutical industry surveillance, medication errors, drug shortages, and therapeutic inequivalence reporting. It does not have oversight over drugs of abuse with no approved medical use.

According to the FDA’s website, “The agency grew from a single chemist in the US Department of Agriculture in 1862 to a staff of approximately 9100 employees and a budget of $1.294 billion in 2001”. The formal agency emerged from the passage of the Federal Food and Drugs Act of 1906.

EMEA

A newer body, the EMEA was developed in 1995. Like the FDA, its main role is “the protection and promotion of public and animal health by regulating medicines for human and veterinary research”. The EMEA is a decentralised body in the European Union (EU), with headquarters in London. As such, the EMEA uses scientific resources from the 25 EU member states.

However, because it is a single agency, companies wishing to apply for a new drug approval file a single marketing authorisation application to the EMEA. Upon review and approval by the Committee for Medicinal Products for Human Use (CHMP), a positive opinion is sent to the Commission, ultimately resulting in a single market authorisation valid for the entire EU.

The CHMP also arbitrates disagreements among member states concerning the marketing authorisation of a particular medicinal product, and can issue an “urgent safety restriction” to inform healthcare professionals about changes in the way a medication can be used (similar to the “black box warning” by the FDA). Moreover, the EMEA is involved in post-authorisation evaluation of drugs for human consumption including pharmacovigilance. The EMEA also reviews applications regarding orphan drugs (ie, drugs for rare diseases) and provides scientific opinion on traditional herbal medicines via the Committee on Herbal Medicine (HMPC), established in 2004.