EMA Spells Out Policies for Orphan Products

The European Medicines Agency has outlined the steps companies should follow once they secure orphan status for a medical product to maintain that status and secure marketing authorization.

The EMA describes these steps in guidance posted Thursday that intends to serve as a one-stop shop for information, with links to necessary documents as well as outside links to potential sources of grant funding and other assistance. It doesn’t introduce any new steps or procedures for companies to follow.

Companies that secure orphan designation for a product must follow certain procedures — such as filing annual reports — but also must take certain steps if they transfer the designation to another entity, change their name or address, attempt to amend an orphan drug designation, seek marketing authorization for that product or withdraw the orphan product designation.

The guidance addresses all the steps companies should follow under these conditions, as well as the opportunities afforded to companies with an orphan drug, such as protocol assistance and inducements offered by various EU member countries.

The document also offers advice on coordinating EMA protocol assistance efforts with requests for scientific advice from the FDA.

Read the guidance here: www.fdanews.com/03-17-16-EMAGuidance.pdf. — Cameron Ayers

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