Regulatory News

EMA Tightens Standards for Drug Naming Requests

European regulatory officials have tightened the standards for obtaining approval for a drug name, reducing the number of proposed names companies can put forth for consideration at any one time.

The change, contained in a revised guideline, on the Acceptability of Names for Human Medicinal Products Processed Through the Centralised Procedure, reduces the number of proposed names that may be sent to the European Medicines Agency (EMA) to two invented names.

At present, companies can submit as many as four names at each Name Review Group (NRG) meeting. In the future, companies will only be able to submit two at any one meeting. If both names are rejected, the company will need to propose up to two new names in a subsequent meeting of the NRG.

EMA said in a statement that the change will not be retroactive, giving companies until 1 January 2015—the implementation date for the guideline—to submit proposed names without penalty.

The NRG will also, in rare cases, be able to make exceptions for companies to submit more than two names, EMA said. Contributing factors might include:

• identification of safety issue/health concern after acceptance of (invented) names
• conditional acceptability of previously reviewed (invented) names
• constraints achieving a global (invented) name
• issues relating to the application of the law on trademarks

In such cases, the marketing authorization holder will need to then indicate which two invented names should be maintained in the marketing authorization application, EMA wrote.

EMA also wrote that the MAHs should "clearly indicate at the time of submission whether the proposed (invented) names are intended to be used in the context of multiple marketing-authorisation applications. This is to allow the NRG to review whether the proposed (invented) names are not potentially confusing with each other."

EMA Guideline

EMA Statement