EMA details new drug supply monitoring system for COVID-19

Regulatory NewsRegulatory News | 21 April 2020 |  By 

The European Medicines Agency (EMA) on Tuesday announced the launch of an “enhanced fast-track monitoring system” to head off potential supply issues for drugs used to treat patients with coronavirus disease (COVID-19).
The new monitoring system, first detailed earlier this month, is modeled after the single point of contact (SPOT) network set up last year between EMA and national regulators for sharing information on shortages.
“Under this system, each pharmaceutical company will appoint a single contact point (an industry single point of contact, or i-SPOC) who will report to EMA and national competent authorities all current and anticipated shortages in medicines used in patients with COVID-19, both for centrally and nationally authorised medicines,” EMA says.
The system is being rolled out in two phases, EMA says, “due to the large number of companies involved.” The first phase began on Friday and focuses on hospital medicines in high demand, including anesthetics, antibiotics, resuscitation drugs and muscle relaxants.
The second phase will cover shortages related to a broader range of medicines used to treat patients with COVID-19. EMA has not elaborated on when it expects the second phase to begin.
The agency says it has already provided a template for reporting current or anticipated shortages to hundreds of drugmakers. The agency also hosted a webinar for drugmakers last week to explain how the new system works.
“The new mechanism will allow better oversight of ongoing supply issues and a quicker flow of information between regulatory authorities in the EU and the pharmaceutical industry with the objective of mitigating and preventing shortages of medicines used during the COVID-19 health emergency,” EMA says.
The agency also notes that drugmakers are still required to report shortages to national regulators according to local laws in each country.


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