Why EMA matters to European citizens

News 23/01/2018

Three videos launched today to explain what EMA is and how it works to help patients

The European Medicines Agency (EMA) has published today three video animations to explain how it ensures that medicines are effective and safe for the benefit of patients across the European Economic Area (EEA).

The first video explains that the Agency assesses, supervises and monitors medicines long before they appear in pharmacies and hospitals, and all the time while they are on the market, by bringing together the best expertise in a European network.

Script: Working for every patient in Europe


When you're sick, you want every chance to get better.


Your doctor will prescribe the best medicine she can provide which could be an innovative treatment.


But who ensures that your medicine works and is safe? The European Medicines Agency is here to protect patients.


Working closely with national authorities, its scientists assess, supervise and monitor medicines long before they appear in pharmacies and hospitals, and all the time while they are on sale.


When a company wants to put a new medicine on the market, they need to send all the available information on how the drug works to EMA. The Agency assesses all the evidence and, if the benefits are greater than the risks, it recommends to the European Commission that the medicine can be marketed in the EU, Iceland, Lichtenstein and Norway.


Since its foundation, EMA has given the green light to over 1000 new medicines, many of which are innovative.


EMA's work doesn't stop here. As long as a medicine is used by patients, EMA looks out for unexpected side effects so it can act quickly to protect the health of people in Europe. The Agency also supports the developers of new medicines and treatments.


To make all of this happen, EMA brings together the best and the brightest minds in a network that spans the whole of the EU.


It means you can trust treatments to be safe, effective and of high quality wherever you are in Europe.


So you can focus on your health, and what's important to you.

The second video describes the journey of a medicine from initial lab tests to its authorisation by EMA.

Script: From lab to patient


Good news! A new medicine has been approved for your disease!


So how did this happen?


Bringing you the latest medicines science can offer takes many years of work.


First, scientists develop a medicine that they think could treat your illness.


Tests in the lab determine if it could work.


If it passes that stage, clinical trials in people check that the medicine does what it's expected to do and is safe.


To then make this medicine available to patients in Europe, a company needs the green light from the European Medicines Agency or EMA. All the information collected during the lab tests and clinical studies goes to the Agency. There, experts from EU Member States assess the evidence.


If the benefits of the medicine are greater than its risks, EMA recommends to the European Commission that the medicine can be marketed across the EU, Iceland, Lichtenstein and Norway.


And while the medicine is on the market, the Agency continues to monitor it.


EMA is part of a network that is there for you when you most need it, so that treatments you can trust are available wherever you are in Europe.

Finally, the third video focuses on how the Agency collects information on side effects from new clinical studies, scientific publications and reports from doctors, pharmacists and patients to keep medicines safe.

Script: Keeping medicines safe


Your medicine is making you feel better… but no medicine is 100% safe, and you notice some side effects.


You tell your doctor about them and she reports them to your national medicines authority. It then sends the information on to the European Medicines Agency, or EMA.


EMA protects patients by making sure that medicines are safe and work. It assesses evidence on new medicines before they can appear in pharmacies in the EU, Iceland, Lichtenstein and Norway and also continues to monitor them while they are on the market.


The Agency looks out for information on side effects. For example:


reports from doctors, pharmacists and also from patients …


new clinical studies... or


scientific publications.


This data gets looked at by some of Europe's best experts in medicines safety.


If they conclude that a medicine has different risks than previously identified, they may recommend a range of actions to the European Commission – for example, the way the medicine is used could be changed or the medicine could be taken off the market.


The Agency constantly monitors medicines on the market


to help you choose the best treatment


and give you peace of mind about your medication.


The videos are available on EMA's website and on the official YouTube channel of the Agency.

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