Defining & Reporting Drug Shortages in the EU - New Guidance
The EMA has produced two guidance documents on how sponsors should identify, notify and address medicines shortages, and how regulatory authorities should communicate information on shortages to the public and health care professionals.
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A public health advocacy group in the EU has issued tangible recommendations to address the perennial problem of drug shortages in the region.
A single point of contact network that is expected to help EU countries share information on medicines shortages has completed its first phase and will be spread more widely this year.
The EU’s new health commissioner, Stella Kyriakides, has outlined the commission’s plans for dealing with medicines access issues in the EU member states. They include completing the review of the EU pediatric and orphan legislation and developing a new strategic plan to tackle shortages and affordability problems next year.