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Regulatory News | 27 January 2015 | By Michael Mezher
Happy birthday! Alles gute zum geburtstag! Joyeux anniversaire! – Happy birthday written in the EU’s three working languages, English, German and French.
If the EU’s medicines regulator were a person, it still wouldn't be old enough to purchase alcohol in the US. Even still, the youthful European Medicines Agency (EMA) says it has much to celebrate this week as it enters its third decade of existence.
To commemorate its 20th anniversary this week, EMA posted a new page to its website highlighting the agency’s major accomplishments since it began operations on 26 January 1995. EMA lists its milestones in a timeline that ranges from the first centrally authorized medicine for human use in 1995 to the 2014 enactment of a new clinical trial regulation.
EMA has accomplished a lot in its short history. Since being founded, the agency has recommended 975 human and 188 veterinary medicines. The agency also oversees seven scientific committees and more than 30 working parties that help guide its actions.
Other highlights include advances made in the regulation of products for rare diseases, herbal medicines, pediatric medicines and advanced-therapy products. More recent milestones include the agency’s recommendations for the first gene-therapy product in 2012 and first stem-cell medicine in 2014.
Even as EMA enters into its third decade, it seems more concerned with what lies ahead than behind. The regulator says it plans to meet in March 2015 to discuss the agency's role "At the crossroads of life science research and development, patient care, public health policy and law.
No word yet on whether the meeting will include a birthday cake.
EMA 20th Anniversary