Medicines can improve lives, but they can also carry risks.
That is why EMA and national competent authorities (NCAs) in each EU country work together to make sure medicines are used as safely as possible.
Before a medicine is approved, we carefully assess its benefits and risks. A medicine can only be authorised if data show that its benefits are greater than its risks.
After approval, we continuously monitor medicines to detect and manage any new safety concerns.
EMA and NCAs share clear, up-to-date information to help patients and healthcare professionals use medicines safely and effectively.
For more information on EMA's work, see:
Select the expandable panels below for a summary of how regulators like EMA help ensure medicine safety at each stage of a medicine's lifecycle.
This summary is part of EMA's booklet on safety of medicines.
Medicine safety evaluation starts long before a medicine is authorised (also referred to as 'approved').
First, developers must test the medicine thoroughly to identify any possible side effects and how often they can occur.
The safety information helps medicines regulators like EMA determine whether a medicine’s benefits outweigh its risks.
This careful balance between benefits and risks is the foundation of every decision to approve a medicine.
For more information, see our interactive timeline on a medicine's lifecycle:
A medicine can get authorisation (also referred to as 'approval') when its benefits outweigh its risks upon scientific evaluation.
When a medicine is approved for use, regulators like EMA set recommendations and measures to minimise these risks.
Patients can find instructions on how to use their medicine safely in the medicine's package leaflet.
Information for healthcare professionals is available in the summary of product characteristics (SmPC).
These safety recommendations help:
However, approval does not mean the end of safety checks.
If a new safety concern is identified once a medicine is on the market, regulators update related safety measures and reflect them in the information for patients and healthcare professionals.
Each medicine also has a safety plan in place from the moment it receives approval. This plan, called risk management plan, helps gather more data over time to better understand the medicine’s safety.
For all medicines authorised via EMA, the package leaflet and SmPC are available in all EU languages on each medicine page, in a document called product information.
EMA makes a medicine finder available to help you learn about medicines authorised for human or veterinary use:
For more information, see:
Responsible authorities monitor a medicine continuously, for as long as it is on the market and used by patients.
When a medicine receives approval, regulators make related safety information available. But some rare or very side effects may only appear after tens or hundreds of thousands of people with different health conditions start using it.
Safety monitoring helps us understand how often known side effects occur and how severe they are in different groups of people with varying health conditions.
EMA and other medicine regulators collect and analyse new data from many sources. This helps detect any new safety issue and take action when needed.
These sources include:
For more information, see:
One of the most important outcomes of medicine safety monitoring is taking action to prevent or reduce harm.
As new data becomes available, regulators may take different steps depending on the seriousness of the safety concern.
These steps include:
For more information, see:
EMA is committed to transparency in how it assesses the safety of medicines.
We publish a wide range for information. This includes:
This allows researchers and the public to see how EMA reaches its decisions on the safety of medicines.
An essential part in upholding medicine safety is making sure medicines are prescribed and taken correctly.
Patients and healthcare professionals must have access to clear, up-to-date information on:
That is why EMA makes it a priority to share new safety information with the public, patients, and healthcare professionals. It is a vital part of protecting public health.
For more information, see:
Patients and healthcare professionals are best placed to understand the effects of medicines ‘first hand’.
The suspected side effects they report are key to identifying new safety issues with medicines.
EMA also consults patients and healthcare professionals as experts.
By doing so, EMA can share their views and insights during the evaluation of medicine safety concerns.
EMA involves patients and healthcare professionals in various ways:
For more information on EMA's work with patients and professionals, see: