Positive scientific opinion from EMA on human insulin with more flexible storage without refrigeration

Novo Nordisk recently announced that the European Medicines Agency (EMA) has granted the company a positive scientific opinion for a proposed update to the storage conditions of two human insulins.

EMA's positive scientific opinion will now be used to support obtaining approval of the more flexible storage conditions by national health authorities in a number of relevant low- and middle-income countries. This to allow that Actrapid® (short-acting insulin) and Insulatard® (intermediate-acting insulin) can be stored for four weeks outside of a refrigerator (if kept below 30° C) prior to use if there are six months or more to the expiry date. Once in use, the insulin should be stored without refrigeration.

The new guidance aims to improve flexibility and convenience for many people with diabetes in low- and middle-income countries, who have limited access to reliable refrigeration, and who may live within long distances from a clinic or pharmacy.