In March 2017, the United States and the European Union initiated their long-awaited Mutual Recognition Agreement, enabling the FDA and EU drug agencies to rely on each other’s Good Manufacturing Practice (GMP) inspection information, and allowing them to avoid duplicating each other’s facility inspections. Their aim, as stated by the European Medicines Agency (EMA) is “to encourage greater international harmonization, make better use of inspection capacity, and reduce duplication.”
While the idea of fewer inspections is a positive for industry – meaning less time will be spent with multiple regulatory agency inspections – each inspection now carries even more weight as it will be accepted by multiple agencies. The result further highlights the need for regulated manufacturers to have a full understanding of the major differences between US and EU regulations, as this is generally where the observations for non-compliance will occur. In essence, understanding both US Food & Drug Administration (FDA) and EMA GMP regulations is now more important than ever.
Using your existing knowledge of US GMP as a starting point, join this course to find out:
- How and where the EU GMP regulations differ from the US GMP requirements
- The most frequently cited regulatory observations by the MHRA & source for information on EMA inspections
- What differences you can expect between US & EMA investigators
- What other MRAs the EMA has in place – who else, other than FDA, may be accepting the results of European Union competent authority audits