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International Collaboration: FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report
Voluntary move can save time, simplify development process
In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions. Both agencies have agreed to accept the submission of a single annual report from sponsors of orphan drug and biologic products designated by both the United States and the European Union...
...The single annual report submission to both regulatory agencies is voluntary and will apply only to sponsors who have obtained an orphan designation status for their product from both the FDA and EMA.
The optional new process for submission will not introduce any additional regulatory requirements. Each regulatory body will conduct their own review and assessment of the annual report to assure the information meets all the legal and scientific requirements of each agency. The FDA and EMA will exchange the annual reports electronically through a secure portal. Starting Feb. 28, 2010 ? World Rare Disease Day ? sponsors may send the single Orphan Drug Designation Annual Report to both agencies. If they choose to do so, a sponsor may submit the report on their normal annual reporting date...
Voluntary move can save time, simplify development process
In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions. Both agencies have agreed to accept the submission of a single annual report from sponsors of orphan drug and biologic products designated by both the United States and the European Union...
...The single annual report submission to both regulatory agencies is voluntary and will apply only to sponsors who have obtained an orphan designation status for their product from both the FDA and EMA.
The optional new process for submission will not introduce any additional regulatory requirements. Each regulatory body will conduct their own review and assessment of the annual report to assure the information meets all the legal and scientific requirements of each agency. The FDA and EMA will exchange the annual reports electronically through a secure portal. Starting Feb. 28, 2010 ? World Rare Disease Day ? sponsors may send the single Orphan Drug Designation Annual Report to both agencies. If they choose to do so, a sponsor may submit the report on their normal annual reporting date...
