FDA, EMA Confidentiality Agreement Expanding Into "Clusters"
The "chatter" between reviewers and scientists at FDA and the European Medicines Agency appears to be increasing as the two bodies move toward renewing their confidential information sharing agreement
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The European Medicines Agency and Japan’s Pharmaceutical and Medical Devices Agency have agreed to share information on the regulatory environment for orphan drugs. The cooperation is aimed at reducing bureaucracy for small- to medium-sized enterprises and improving the authorization process.
An agreement with the European Medicines Agency likely would be necessary for therapies designated as breakthroughs to ensure expedited clinical program would be accepted in both jurisdictions.
FDA, the European Medicines Agency and the pharmaceutical industry have embarked on a new cooperative effort to develop solutions to drug-related progressive multifocal leukoencephalopathy – a collaboration that could be a springboard for better disease/drug-specific cooperation.