EMA Revises Guideline on Acceptability of Names for Human Medicines

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-04-2014 10:39


The European Medicines Agency has published a revised guideline on the acceptability of names for human medicines processed through the centralized procedure.

The revised guideline introduces a substantial change with regard to the name submission rules: up to two proposed (invented) names per marketing-authorization application can be accepted by the agency’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.

Sponsors can currently propose up to four names.

This reduction in the number of proposed names allowed has no retroactive effect. Therefore, all (invented) names accepted prior to the implementation of the revised guideline will be retained. The final NRG meeting where four proposed names can be accepted will be held on November 26, 2014. All subsequent name review requests should adhere to the new rules.

The updated guideline will come into effect on January 1, 2015.

The overview of comments received during the public consultation on this revised guideline will be made available by the beginning of July, according to EMA.

Early this month, the US Food and Drug Administration issued draft guidance for developing proprietary names for drugs. See related story, "FDA Issues Draft Guidance for Developing Proprietary Names for Drugs"

Source: EMA


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