EMA Issues Guidance on Drug Shortages
The European Medicines Agency released two guidances on medicine shortages for drugmakers and EU regulators — and said the lack of a common definition has meant that the management of shortages in the European Union has been “inconsistent.”
The guidance for the pharmaceutical industry establishes a common definition of the term “shortage,” as an event that “occurs when supply does not meet demand at a national level.”
The guidance also covers the responsibilities of firms in monitoring their supplies and reporting problems. It includes a proposed template for shortage notifications. The agency said the guidance and template will be “implemented in a pilot phase, which is currently planned to start in the last quarter of 2019.”
A second guidance document was directed at EU regulatory authorities. The document includes templates and best practice guidance to improve communication and “to maintain and improve trust in the regulatory system,” the agency said.