EU Looks to Craft Harmonized Definition of a Drug Shortage

Regulatory NewsRegulatory News
| 11 February 2019 | By Zachary Brennan 

Part of what’s holding back a more concerted European-wide push to combat and manage drug shortages is a harmonized definition for a shortage, according to a report released Monday on a November meeting discussing the availability of authorized medicines.

“The lack of a European-wide definition for shortages has long been a factor hampering a harmonised European-wide approach to managing shortages,” the report says.

Annette Byrholt Hansen from the Danish medicines Agency presented a draft proposal for a harmonized definition at the meeting: “A shortage of a medicinal product for human and veterinary use occurs when supply cannot meet demand at a national level.”

And the report notes that this definition meets the meeting’s task force’s necessary and measurable elements and is “simple, short and concise.”

But further harmonization is necessary on a wider scale so that member states can collect information on shortages that can be used in comparisons across the EU.

The European Medicines Agency’s (EMA) Brendan Cuddy presented the outcome of a survey of national competent authorities showing that one-third of EU/EEA member states collect and evaluate information on shortages, but the type of data gathered varies from one member state to another.

“The survey identified key information necessary to adequately describe shortages which was used to design a template for marketing authorisation holders to notify national competent authorities of shortages. The layout is simple, allowing for collection of the minimum amount of information required for assessment. It is hoped that with the feedback gathered through the survey a European-wide unit of measure for shortages can be found to facilitate measurement of supply chain performance and comparison across the EU,” the report says.

Stakeholders also suggested a risk-based approach when reporting shortages that accounts for the probability of a shortage occurring, the criticality of a medicine and the manufacturing sources for the medicine. The report further considers requirements for a minimum period of time before a shortage qualifies as a disruption of supply.


The push for a harmonized definition comes as the outcome of EMA’s latest assessment of industry’s preparedness for Brexit shows that for 19 centrally authorized human medicines, the necessary actions will not be carried out in time.

“This is an evolving picture and EMA continues to monitor the situation. For any medicines considered at risk, EMA is carefully analysing how to minimise supply disruptions and any resulting impact on public and animal health,” the report adds.



© 2022 Regulatory Affairs Professionals Society.

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