Module 1 2021

FDA/EMEA Interactions • The relationship between the FDA and EMEA has become closer since the end of the 1980s • September 2003, confidentiality agreement announced (allowed Agencies to share non-public information, including ‘pre-decision’ information, early policy documents etc.) • Integrated approach taken for ‘clusters’ of products e.g. oncology, pharmacogenomics, vaccines, veterinary medicines and advanced therapies. • Reciprocal staff placement program • Aim for the Agencies to not simply ‘ receive ’ but to ‘ rely ’ on shared information – e.g., GCP inspections • Increased activity in Risk Management and Pediatrics

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FDA International Interactions

• Relationships and communications between FDA and other International Agencies are improving/increasing • Confidentiality agreements in place between FDA and Health Canada, Mexico, Japanese Ministry of Health Labor and Welfare, Australian TGA, New Zealand, Singapore and several EU MS (e.g. Ireland, UK, France, Belgium, NL, Germany, Austria, Denmark and Sweden. • Introduction of overseas posts e.g. Offices in China and India with regional inspectors

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