EMA Update: 25 Human Drugs at Risk of Brexit Supply Disruptions

September 26, 2018

The EMA lowered its estimate for the number of centrally authorized drugs that may face post-Brexit supply disruptions from 108 to 39 — including 25 human medicines.

The agency revised its projections after following up with marketing authorization holders of the 108 medicines previously found to be vulnerable after the UK exits the European Union on March 29, 2019.

A July survey found that over half of marketing authorization holders — 58 percent — of the 694 meds that had “an important step in their regulatory processes in the UK” were on track to ensure that their authorizations remain valid post-Brexit. However, 108 medicines — including 88 human ones — were deemed to have serious supply concerns.

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