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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

FDA, EMA Agree on Mutual Reliance

Mar 13, 2017, 07:57 AM
News Source Link:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544357.htm
RegulatoryNewsDate:
Mar 10, 2017, 15:49 PM

In early March, both the US FDA and EMA announced that the European Union and United States have agreed to recognize each region’s GMP inspections of pharmaceutical manufacturing facilities. This agreement follows three years of work between both agencies on the Mutual Reliance Initiative. Mutual recognition of inspections is expected to result in avoidance of duplicate inspections, reduced inspection costs, and allows regulators to better allocate resources to other regions that present greater risks.

The European Union is expected to have completed its assessment of FDA by Nov. 1, with FDA having completed its own assessment of eight EU member states.

regulatory-news-regions:
  • North America
  • Europe