7. Regulatory measures to control risk

7.1 Drugs under closer surveillance

Since April 2013, a European list of drugs under enhanced surveillance has been revised monthly by the PRAC and published by the EMA and ANSM. Their inclusion on this list means that they are monitored more closely than others. A drug may be included on this list when it is granted marketing authorization, or at any time during its life cycle. It remains under surveillance for five years, or until the PRAC decides to remove it from the list. The reason for this is the lack of experience, due to the fact that they have only recently been put on the market, or to a lack of data on their long-term use. Drugs under enhanced surveillance are identified by the presence of an inverted black triangle (also known as a black symbol) in the patient information...