Monitoring the safety of medicinal products

All medicines marketed and used in Finland must have a marketing authorisation or a registration. A pharmaceutical company must apply for the marketing authorisation themselves. Based on the information entered in the application, Fimea verifies that the medicinal preparation meets the requirements for efficacy, safety and quality.

A medicinal preparation is carefully examined before it is marketed, and its safety is monitored also when the preparation is on the market. Pre-marketing control takes place before a marketing authorisation or registration is granted and post-marketing control takes place after the marketing authorisation or registration has been granted.

The purpose of pre-marketing control is to ensure that the benefits of the medicine are greater than its adverse effects or risks. The purpose of post-marketing control is to obtain additional information on the safety of the medicine.

A medicine that has been granted a marketing authorisation has been studied in controlled circumstances on a few thousand patients at most. In real life, the medicine is used by a much larger and diverse group of patients. They might have other illnesses or use other medicines whose interactions with the new medicine are not necessarily known yet.

Moreover, rare adverse reactions might not become apparent before the drug has been used by a large number of people. This is why it is extremely important to monitor the safety of medicines also after the marketing authorisation has been granted.