EMA Task Force to Implement Standards for Identifying Medicines

Sunday, March 1, 2015

Source: FDA News

The European Medicines Agency is establishing a task force to implement common standards for identifying medicines across EU member states, and will require industry and regulators to comply with them beginning in July 2016.

The goal of the common terminology is to improve safety monitoring of medicines across countries in Europe.

The task force will be comprised of about 60 representatives from the EMA, member state authorities, drug companies, software and service providers, developers of medical dictionaries and databases and should complete its work by the end of 2015.

The standards will define the terminology pharma companies and regulators must use when describing a drug’s characteristics, such as strength, reference strength, route of administration, ingredients and patient population.

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