Region: EUROPE | Type: Regulation | Keywords: #covid19 #drugshortages #drugsupply #ema #executivesteeringgroup #i-spoc #pharma
PRICENTRIC BRIEF:
- To mitigate supply disruptions, the EU Executive Steering Group of Shortages of Medicines Caused by Major Events, is currently setting up, along with the pharmaceutical industry, a system, the i-SPOC (industry single point of contact) system, to fast-track interaction on shortages between the industry and EU Executive Steering Group
- The i-SPOC system is based on the appointment of an i-SPOC in each pharmaceutical company who is responsible for feeding information on current or anticipated shortages, both for centrally authorized and nationally authorized medicines, used in the context of COVID-19 to the European Medicines Agency (EMA)
- EMA and the EU network are also considering mitigation measures such as regulatory actions to support increased manufacturing capacities, e.g. through speeding up the approval of a production capacity for all medicines used in the context of COVID-19, and in particular for medicines potentially at risk of shortages
THE DETAILS
AMSTERDAM, The Netherlands – Since some EU Member States have indicated that they are starting to see shortages of certain medicines used for patients with COVID-19 or are expecting shortages to occur soon, EU authorities are putting in place additional measures to mitigate the impact of the pandemic on the supply chain of medicines.
Amid the COVID-19 pandemic, lockdown during quarantine, border closures, export bans, increased demand, and both hospital and citizen stockpiling have affected the supply of medicines. To prevent stockpiling, some EU Member States imposed restrictions on the number of packs that can be prescribed to or purchased by patients.
To mitigate supply disruptions, the EU Executive Steering Group of Shortages of Medicines Caused by Major Events, is currently setting up, along with the pharmaceutical industry, a system, the i-SPOC (industry single point of contact) system, to fast-track interaction on shortages between the industry and EU Executive Steering Group.
Pharmaceutical companies will report directly to the European Medicines Agency (EMA), both for centrally authorized and nationally authorized medicines, anticipated shortages or current shortages of critical medicines used in the context of COVID-19.
Companies should nevertheless still continue to report to the national competent authorities concerned as well.
The i-SPOC system is based on the appointment of an i-SPOC in each pharmaceutical company who is responsible for feeding information on current or anticipated shortages of COVID-19-related medicines to EMA.
EMA and the EU network are also considering mitigation measures such as regulatory actions to support increased manufacturing capacities, e.g. through speeding up the approval of a production capacity for all medicines used in the context of COVID-19, and in particular for medicines potentially at risk of 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.
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