EMA publishes first two Guidances on Drug Shortages

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

Regulators in the European Union have taken first steps to diminish shortages of medicinal products. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation or first step for a long way:
how to define and how to communicate drug shortages.

What sounds to be a simple guidance is however an important first step towards resolving problems leading to supply-chain issues and shortages of medicinal products. In the "Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders (MAHs) in the Union (EEA)", the authors state that "lack of a common definition has meant that the detection and coordination of the management of shortages in the Union (EEA) has been inconsistent". The document then addresses the following questions:

• What is a shortage?
• What issues should be reported by MAHs?
• Who is responsible for monitoring supply and reporting shortages?
• When should a notification be made?
• Who should be notified?
• What information should be included in notifications?

The "Good practice guidance for communication to the public on medicines' availability issues" then gives recommendations for EU national competent authorities and the EMA to ensure adequate public information addressing the following questions:

• Who should communicate
• Who is the target audience
• Which format or tools
• What information to be published
• When to publish
• How to involve stakeholders in the preparation and dissemination of information
• Internal collaboration
• Examples of communication to the public and interaction with stakeholders

As said before, this is certainly not a significant step and the solution for all the current problems. But it is at least a first step. But there has to be a lot more to come and certain tasks have to be tackled, which might cause shortages:

• Globalisation with too few production sites for active substances
• Relocation of drug production to low-wage countries
• Complex supply chains
• Parallel ex- and imports
• GMP deficiencies
• Manipulated bioequivalence studies