miércoles, 21 de abril de 2010

European Medicines Agency - Human Medicines - Orphan medicinal products - Orphan designation - Annual report on development


Orphan designation - Annual report on development
Sponsors of designated orphan medicinal products are required to submit to the EMA an annual report on the development of their product. The guideline below provides advice on the preparation of these reports.

•FDA and EMA Agree to Accept a Single Orphan Drug Designation Annual Report
•COMP/189/01 Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal product (Adopted by COMP April 2002 Final) (Rev. 2 21/04/10) Updated on miércoles, 21 de abril de 2010

open here to see the original document from EMA:
European Medicines Agency - Human Medicines - Orphan medicinal products - Orphan designation - Annual report on development

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