EMA Changes Guideline on Drug Name Acceptability

The European Medicines Agency (EMA) has revised its guideline on the acceptability of names for drugs processed through their centralized procedure. The revised guideline changes the name submission rules and will come into effect on Jan. 1, 2015.

The revised guideline specifies up to two proposed (invented) names per marketing-authorization application can be accepted by EMA’s Name Review Group (NRG) and a maximum of two (invented) names per name review request can be proposed for consideration at each NRG meeting. The previous rules allowed sponsors to propose up to four names. EMA states that this rule is not retroactive and, therefore, “all (invented) names accepted prior to the implementation of the revised guideline will be retained.” All name review requests presented after the Nov. 26, 2014 NRG meeting should adhere to the new rules.