EMA, FDA Discuss Mutual Recognition, Generics at Annual Meeting

Representatives from the FDA and the European Medicines Agency discussed further opportunities for collaboration in their 2018 annual meeting last week.

At the June 18-19 meeting, representatives discussed the two agencies’ mutual recognition agreement that took effect in November 2017, allowing the institutions to recognize one another’s manufacturing site inspection outcomes.

During the meeting, the agencies committed to including vaccines and plasma-derived drugs in the scope of the agreement no later than July 2022.