coronavirus
EU authorities agree new measures to support the availability of medicines for #COVID-19 pandemic #EMA
Some member states have indicated that they are starting to see shortages of certain medicines used for patients with COVID-19 or are expecting such shortages to occur very soon. These include medicines used in intensive care units such as certain anaesthetics, antibiotics and muscle relaxants as well as medicines used off-label for COVID-19.
To help mitigate supply disruptions, the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, which provides strategic leadership for urgent and coordinated action on shortages within the EU in this pandemic, is currently setting up, with the pharmaceutical industry, a system, the i-SPOC (industry single point of contact) system, to fast-track interaction on shortages between industry and the EU Executive Steering Group.
The i-SPOC system, which is similar to the single point of contact (SPOC) network which was set up in 2019 between EMA and the national competent authorities to share information on medicine shortages, is based on the appointment of an i-SPOC in each pharmaceutical company, who will feed information on current or anticipated shortages of COVID-19-related medicines to EMA. This new mechanism will allow better oversight of ongoing supply issues irrespective of the licensing route and a quicker flow of information with the pharmaceutical industry with the objective of mitigating and, if possible, preventing shortages in the context of COVID-19 medicines.
In the context of the pandemic, EMA and the EU network are considering mitigation measures such as regulatory actions to support increased manufacturing capacities, e.g. through speeding up the approval of a new manufacturing line or site. Discussions are also ongoing with the pharmaceutical industry to increase production capacity for all medicines used in the context of COVID-19, and in particular for medicines potentially at risk of supply shortages.
In addition, the EU Executive Steering Group is considering areas where regulatory rules could be applied with greater flexibility during the pandemic to secure supply of critical medicines.
The EU Executive Steering Group on Shortages of Medicines Caused by Major Events is chaired by the European Commission. Its membership is made up of representatives from the European Commission, the Heads of Medicines Agencies (HMA), EMA, the chairs of the Coordination groups for Mutual-recognition and Decentralised Procedures for both human and veterinary medicines (CMDh and CMDv), as well as risk communication specialists.
Information on ongoing medicine shortages in the EU is available in the relevant national shortages registers and EMA's shortages catalogue.
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