A Look at the European Medicines Agency

Streamlining the Process
The Three Procedures
EMA’s Scientific Evaluation
Two Sides of the Pond but One Goal
More Information

The motto of the European Medicines Agency (EMA) is "Science Medicines Health." These three words signify the mission of EMA: to make science-based decisions, to regulate medicines, and to promote human and animal health.

EMA has a similar role as FDA in the review and approval of certain drugs for people and animals in the European Union (EU). The EU’s definition of a veterinary medicinal product closely matches the definition of an animal drug in the United States. In the EU, a company can market a veterinary medicinal product only after a marketing authorization has been issued by an EU member state or by the EU Commission through EMA. Before the EU member state or the EU Commission issues a marketing authorization, the company must submit a marketing authorization application, called the “dossier.” The dossier includes data from studies showing the product’s quality, safety, and effectiveness.

FDA’s approval of an animal drug is similar to an EU marketing authorization for a veterinary medicinal product. The dossier’s equivalent is the New Animal Drug Application (NADA) that a company must submit to FDA. The NADA includes all the safety and effectiveness information about the animal drug. FDA must approve the application before the company can market the drug in the United States.

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Streamlining the Process

Before 1995, there were 15 National Regulatory Authorities in the European Union. For a drug to reach the entire EU market, a company had to submit a dossier to each regulatory authority separately. The product had to go through 15 national assessments and have 15 independent marketing authorizations, with potentially divergent scientific outcomes. New legislation was passed in 1995 and 2004 to streamline the process for getting products to the European marketplace. Now, there are two authorization systems – the National Authorization system and the EU Authorization system.

If a company wants to get a veterinary medicinal product, or animal drug, approved in just one EU member state, the company uses the National Authorization system. In this case, the company applies to Spain, for example, and if the application is successful, receives a marketing authorization for Spain only.

If a company wants to get an animal drug approved in more than one member state or in the entire EU, the company must use the EU Authorization system. In this system, a company can take one of three routes to get a drug to the European marketplace:

Mutual recognition procedure;
Decentralized procedure; or
Centralized procedure.

The route a company can take depends on the type of drug, its marketing authorization history in the EU, and the company’s preference and marketing strategy.

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The Three Procedures

The mutual recognition procedure was created in January 1995. In this procedure, a company applies to one EU member state (let’s say Spain again). Spain assesses the company’s application, and if the application is successful, issues a marketing authorization so the company can market the drug in Spain. The company then applies to a certain number of other EU member states (let’s say eight). These eight states receive the marketing authorization application and assessment report from Spain, and are asked to “mutually recognize” the Spanish assessment. If none of the eight states have serious objections, the company is issued a national marketing authorization in those eight countries.

In the decentralized procedure, the company--which does not yet have a marketing authorization for the drug in any EU member state--submits parallel applications to a certain number of states (let’s say eight again). One “reference” member state assesses the application. The assessment is peer-reviewed by the seven other member states. After the eight states agree on the assessment, the company is issued a national marketing authorization in those eight countries. This procedure was created in November 2005.

The centralized procedure is where EMA comes into the picture. EMA manages the centralized procedure, which has been in place since January 1995. Only some products, generally ones that are innovative, are eligible to take this route. Of these eligible products, some are required to use the centralized procedure, while it is voluntary for others. For example, a drug developed using biotechnology or another high-tech process must go through the centralized procedure. This route is optional for other innovative products, such as an already authorized drug delivered to the patient in a new way.

In the centralized procedure, the company submits one application to EMA. One scientific evaluation is done by the relevant EMA scientific committee, resulting in one scientific opinion on the application. Based on a positive opinion, the EU Commission issues one marketing authorization that is valid for the entire EU. The drug has one trade name and one label. Product information on the drug’s label must be translated into all European languages.

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EMA’s Scientific Evaluation

EMA has seven scientific committees which evaluate various products. For an animal drug, the Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for the scientific evaluation. Experts from all EU member states are on the CVMP. The Rapporteur, or lead reviewer on the dossier, prepares an overview of the committee’s scientific evaluation, called the CVMP Assessment Report. The Rapporteur works with the Co-Rapporteur and EMA representative to write the report.

The CVMP Assessment Report:

Summarizes the data submitted by the company on the product’s quality, safety, and effectiveness;
Explains the assessment done by the CVMP to support the committee’s recommendation to the EU Commission to issue a marketing authorization; and
Is the basis for the European Public Assessment Report (EPAR) published on EMA’s website.

The EPAR can be compared to the Freedom of Information (FOI) Summary published on FDA’s website. The FOI Summary is a public document describing the safety and effectiveness information that supports FDA’s decision to approve a new animal drug. It includes summaries of studies that were done and explains the basis for the agency’s approval.

CVMP has mandatory timeframes to complete the scientific evaluation and issue a scientific opinion on the application. FDA has similar mandatory timeframes for reviewing human and animal drugs. Another similarity between EMA and FDA is found in the budget for each agency. About 85 percent of EMA’s budget comes from fees and administrative charges paid by companies to support the agency’s review of medicinal products. The European Union contributes 7 percent of the funding for public health issues and 8 percent comes from other sources. In the United States, Congress appropriates some of FDA’s budget. The rest of the agency’s budget comes from user fees paid by companies to support FDA’s review of human and animal drugs.

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Two Sides of the Pond but One Goal

While the specific procedures may differ, FDA’s Center for Veterinary Medicine (CVM) and EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) have the same goal: to make sure safe and effective drugs are available for animals. Many of the responsibilities of CVM and CVMP are the same, such as:

Reviewing safety and effectiveness data for new animal drugs;
Monitoring animal drugs after they reach the market;
Issuing scientific guidelines for companies;
Offering scientific advice to companies; and
Contributing to the VICH process.

VICH stands for International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. VICH is a trilateral program of the European Union, Japan, and the United States. The program, coordinated by OIE (World Organisation for Animal Health), was formed to harmonize the guidelines for animal drug studies among participating countries

The European Medicines Agency and FDA’s Center for Veterinary Medicine regularly share information about animal drugs under confidentiality agreements. This information exchange is an efficient use of both agencies’ resources and supports a global approach to drug development, approval, and monitoring. With international cooperation between agencies, more safe and effective animal drugs may be available sooner, on both sides of the pond.

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