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FDAnews Drug Daily Bulletin

EMA to Juggle Brexit and New Quality and Safety Guidelines Next Year

Dec. 29, 2017

In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component.

However, the goals could be subject to change — especially as the EMA faces a challenging year with the changes brought by Brexit, according EMA’s Executive Director Guido Rasi.

The quality and safety working groups’ work plans list the EMA guidelines, reflection papers and other documents they hope to produce, with quarterly target dates, over the next three years.

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