EMA Publishes Plan to Help Deal With Manufacturing-Related Medical Product Supply Shortages

In light of an increased occurrence of medicinal product shortages over the last few years, the EMA has published a reflection paper to provide a plan to help deal with manufacturing-related supply issues.

The paper summarises the lessons the Agency has learned from previous manufacture-related medical product supply crises in which it played a supporting or coordinating role and provides a short- and medium-term plan to help the European medicines regulatory network prevent, mitigate and manage shortages of important medicines.

Short-term actions outlined in the paper include measures to catalogue medicinal products requiring coordination at EU level and maintain a public list of ongoing shortages where EMA coordination of assessment has been undertaken. MA holders will be invited to report shortages caused by manufacturing/GMP compliance issues on a voluntary basis.

The full press release, together with the reflection paper and its implementation plan, can be found on the EMA’s website here.