EMA’s new Q&A re: orphan medicines

EMA has recently published a question-and-answer document, addressing common misunderstandings about the meaning of orphan designation and other aspects pertaining to orphan medicines. Here we have a document that explains key concepts in the regulation of medicines for rare diseases such as orphan designation and significant benefit.

Hemex frequently submits ODD applications for Sponsors of drugs targeting rare diseases. Contact us today for free, confidential advice supporting your plans and projects.

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