New system to speed industry-EMA interactions on drug shortages

Regulatory NewsRegulatory News
| 06 April 2020 | By Zachary Brennan 

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events is currently establishing, with the pharmaceutical industry, the i-SPOC (industry single point of contact) system to speed up interactions on drug shortages between industry and the steering group, the European Medicines Agency (EMA) said Monday.

Although medicine shortages are dealt with at the national level in the EU by national competent authorities, under this new system each pharmaceutical company will report anticipated shortages or current shortages of critical medicines used in the context of COVID-19 directly to the EMA both for centrally authorized and nationally authorized medicines.

Companies will continue reporting such shortages to the national competent authorities too, EMA adds.

Currently, EMA is also proactively gathering information from member states to monitor or anticipate EU-level shortages in hospital settings. The agency also has also liaised with member states regarding how the export ban on 14 active pharmaceutical ingredients from India impacts the availability of certain medicines in member states.

“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,” EMA said.



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