FDA Versus EMA: What Clinical Research Labs Need to Know?

Deploy a Laboratory Software for Clinical Research to Meet the FDA & the EMA requirements

In the last decade, efforts have been made to bring scientists and health professionals from across the world to work together toward implementing and accelerating global research. To achieve this, there’s a need for harmonizing and streamlining regulatory standards and research processes across the board.

In the U.S., the Food and Drug Administration (FDA) regulates the drug and biologic approval process while the European Medicines Agency (EMA) does the same for the European Union (EU), and the Economic Area-European Free Trade Association (EEA-EFTA) countries of Iceland, Norway, and Liechtenstein. It is important to note that the EMA regulations do not apply to the UK since BREXIT happened on January 31, 2020. This article explores the similarities and differences that exist between the FDA and the EMA processes as applicable to clinical research. 


The US Food, Drug, and Cosmetic Act was passed in 1938 to safeguard public health and ensure that drugs, biological products, medical devices, and foods and cosmetics are safe and effective for public use. The FDA supports this goal by reviewing both preclinical and clinical research. 


The EMA was established in 1995 to review and approve medicinal products before they are marketed in the EU, Iceland, Liechtenstein, and Norway.

The FDA and the EMA have the same goal, which is to promote and protect public health by evaluating the safety and efficacy of pharmaceuticals and working collaboratively with clinical research experts and stakeholders. However, the two agencies differ in how they implement their broad objectives.

Regulatory Oversight 

The FDA oversees drug development processes in a single country, while the EMA does the same for several countries that are part of the EU. Decisions made by the EMA must be approved by the European Commission. This makes the drug approval process in the EU slow and less efficient. A study that was published in the British Journal of Clinical Pharmacology in 2019 found that the median review time for drugs approved by the EMA was longer compared to the FDA. This is especially the case for the drugs under FDA expedited programs.

Drug Development Process

Both the FDA and the EMA require preclinical studies, clinical trials that run through three phases, and a final approval process before drugs can be introduced to the market. The FDA requires that an investigational new drug application is filed that proves that the new drug has demonstrated safety in the preclinical phase. The EMA requires a centralized authorization procedure that can be used in all 27 EU member states and EEA-EFTA countries. Moreover, the EMA is responsible for the marketing authorization, the member states are responsible for enforcement, licensing, and for sales and promotional activities for a drug. 

The FDA requires that new drugs are compared against a placebo during clinical investigations. On the other hand, the EMA requires that new drugs are compared against existing drugs. In some cases, the EMA requires a three-armed study where the new drug is compared against a placebo and an active treatment. 

Similarities Between the FDA and the EMA

Recently, the FDA and the EMA standardized their orphan medicines designation process by adopting a common application form for orphan drugs that can treat rare diseases. Both agencies now define rare diseases as diseases that affect “fewer than five in 10,000 people in the EU and fewer than 200,000 people in the United States.” Such standardization makes it possible for research sponsors to use a single application to apply for research permissions in both jurisdictions, which makes the process simpler and more efficient. 

A study published in Clinical Pharmacology and Therapeutics in 2020 compared the FDA and the EMA decisions for new drug marketing applications between 2014 and 2016. The researchers found that the two agencies had a high concordance on decisions made for drug marketing approvals, 91% to 98%. This confirmed the positive impact of collaboration between the two agencies.  

How Does a Laboratory Software for Clinical Research Support Regulatory Compliance?

Both the FDA and the EMA have numerous requirements for laboratories that conduct clinical research. A Laboratory Information Management System (LIMS) supports regulatory compliance through automation, boosting efficiency and accuracy of laboratory processes. A laboratory software for clinical research anonymizes the sensitive data of participants and assigns role-based access to staff to prevent unauthorized use of data. A laboratory software for clinical research manages the informed consent of participants, clinical trial results, documents, laboratory equipment, and staff training. It also enforces staff to follow the standard operating procedures at all times and track deviation, enabling standardization across geographies. Furthermore, a laboratory software for clinical research helps manage clinical studies, patient records, patient demographics, drug administration and their effects. Furthermore, it generates custom reports, enabling researchers to make data-driven decisions. 

A cloud-based laboratory software for clinical research ensures greater security and remote access at any time and from any location.


The FDA has some advantages over the EMA because it governs a single country. During a crisis, decisions can be made faster since the FDA doesn’t need to coordinate among several countries. The EMA, unlike the FDA, does not have the final say on drug approval as this is the mandate of the European Commission. At the same time, member states are individually responsible for enforcing decisions made by the EMA. 

A laboratory software for clinical research can help clinical research laboratories meet various national and international regulatory requirements and standardize processes through automation, enabling researchers to accelerate trials and the drug discovery process.

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