European Medicines Agency's (EMA) Process for Vaccine Approval

As each new COVID-19 vaccination is announced, every region waits for approval for distribution to begin. The UK was the first country to approve the first vaccine, with the FDA in the United States of America following soon after. 

Citizens in the European Union patiently waited for EU approval as they watched other countries begin distribution. Finally, at the end of December, the EMA announced the approval of the Pfizer and BioNTech vaccination. 

So who is the EMA and how do they approve new vaccinations?

The EMA’s purpose is to protect human and animal health by approving and monitoring medicines and providing transparent clinical data for both patients and healthcare professionals. 

For a medicine like the COVID-19 vaccine to be approved by the EMA, the company developing the medicine must submit data showing they have completed three types of studies: pharmaceutical quality studies, non-clinical studies, and then clinical studies. 

Pharmaceutical quality studies are to gather information for the ingredients that go into the medicine, how it is manufactured, and how to store the medicine. The use of each ingredient must be justified as well as the manufacturing technology being used. 

The next step is non-clinical studies, studies conducted in the laboratory. The company will need to prove that giving an animal the medicine accomplishes the desired goal. This step also gives information on how the immune system responds to the medicine and how the medicine reaches the tissues and/or organs in the body. 



The final study for EMA approval is the clinical studies where the safety and efficacy of the medicine must be proven on humans. Participants and volunteers in these studies are protected by authorities and ethics committees in each nation of the EU. That said, to meet the approval standards of the EMA, the clinical study must comply with good clinical practice (GCP). 

A very important study during this step is the efficacy study. Efficacy is the medicine’s ability to produce the desired effect in ideal situations. Many efficacy studies can be conducted, with varying numbers of participants, but there has to be one main study with over 30,000 participants to truly prove the efficacy of a medicine. 

There isn’t a minimum efficacy percentage needed for EMA approval. It is recommended to be at least over 50% but they compare the efficacy rating to the levels of safety and side effects and ease of storage. A medicine with lower efficacy but high levels of safety and few side effects might be approved quicker than a vaccine with a high efficacy rating that comes with numerous side effects. 



After approval, long-term clinical studies are essential to continue gathering information on the safety and efficacy of a medicine. While not a part of the EMA’s approval process, this is necessary for many situations but especially with a medicine or vaccine for a virus. As a virus can grow and mutate, long-term studies will provide updated information on the safety and efficacy of the medicine in current, real-world situations. 

Are you looking to expand your knowledge of the EMA and EU regulations? Then make sure to sign up for our European Regulatory Procedures course today.

Our European Regulatory Procedures course will be of value to both those who are new to Regulatory Affairs in the pharmaceutical, biopharmaceutical, and generic drug industries, as well as experienced professionals wishing to refresh their regulatory knowledge.

Have questions? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].