Europe – EU actions to support availability of medicines during COVID-19 pandemic – update #3

ThEU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual meeting on 22 April 2020 to discuss the measures adopted to safeguard the supply of medicines during the ongoing COVID-19 pandemic for European patients.

EMA has provided an update on the i-SPOC (industry single point of contact) system, a fast-track monitoring system to help prevent and mitigate potential shortages of medicines launched on 17 April 2020. The i-SPOC allows each pharmaceutical company to report any issues related to the availability of both centrally and nationally authorised medicines for use in COVID-19 patients directly to EMA, in addition to national shortage reporting requirements. In this early phase the system is focusing on a subset of medicines being used in intensive care units (ICUs) across Europe and first reports have been received. Further updates on the i-SPOC activity will be provided as the implementation of the system progresses.

The European Commission, EMA and the Heads of Medicines Agencies (HMA) are currently working to consolidate the feedback received from stakeholders regarding the question-and-answer (Q&A) document that provides guidance on adaptations to the regulatory framework aimed at addressing challenges arising from the current pandemic. EU authorities are also considering a further update of the measures for marketing authorisation holders (MAHs) of human medicines, and further information will follow…