EMA Changes Guideline on Drug Name Acceptability - - BioPharm International

ADVERTISEMENT

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.

Source: European Medicines Agency

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines

Click here