This content applies to human and veterinary medicines.
This page contains information related to medicine shortages and how they are reported and assessed by the European Medicines Agency (EMA).
On this page
- Overall framework
- EU-level coordination to ensure medicines availability
- Existing support for regulators
- Public information on shortages
In the European Union (EU), most medicine shortages are dealt with at national level by the national competent authorities.
However, EMA can be involved in certain situations, for example when a medicine shortage is linked to a safety concern or affects several Member States.
Medicine shortages can occur for many reasons, such as manufacturing difficulties or problems affecting the quality of medicines that can impact on patient care.
Regulatory authorities within and outside Europe are increasingly working together to prevent shortages and to limit their impact whenever they occur. The European regulatory network aims to minimise the impact of medicine shortages on patients by:
- working with pharmaceutical companies to resolve manufacturing and distribution issues;
- sharing information with international partners about alternative sources of supply;
- seeking input from patients and healthcare professionals on the impact of medicine shortages, to support decision-making;
- taking measures to allow alternative medicines or suppliers to be used.
For more information, see Quality defects and recalls.
EMA and the Heads of Medicines Agencies (HMA) created an HMA/EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use in December 2016 to provide strategic support and advice to tackle disruptions in supply of human and veterinary medicines and ensure their continued availability.
Its key priorities include:
- looking at ways to minimise supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework (for example by work sharing and reduced timetables when possible);
- developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain (for example developing guidance for companies on reporting of shortages);
- encouraging best practices within the pharmaceutical industry to prevent shortages;
- improving sharing of information and best practices among EU regulatory authorities to better coordinate actions across the EU;
- fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens.
For more information on the task force's work and composition, see:
EMA has published a set of documents to support regulators involved in coordinating shortage situations due to good manufacturing practice (GMP) non-compliance:
- Criteria for classification of critical medicinal products
- Decision tree on escalation from national to European level
- Points to consider for the overall assessment of a supply shortage of a medicinal product due to GMP Non-compliance /quality defects
- Closing report on assessment of a supply shortage of a medicinal product due to manufacturing and quality problems
- Resources for issuing treatment recommendation during shortages of medicinal products
- Risk indicators for Shortages (Manufacturing and Quality)
The documents for regulators build on an EMA reflection paper on public health incidents that can arise due to manufacturing disruptions and an implementation plan to coordinate the assessment of shortages, develop risk-minimisation measures, alleviate the impact on patients and communicate within the European medicines regulatory network:
- Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems
- Implementation plan 2012-2015
They also draw on input from an EMA workshop on product shortages due to manufacturing and quality problems in 2013 and a stakeholder meeting to review progress in 2015:
- Developing a proactive approach to the prevention of medicines shortages due to manufacturing and quality problems: Report from stakeholder meeting
In line with the implementation plan, EMA has established a public shortages catalogue that have been assessed by the EMA's Committee for Medicinal Products for Human Use (CHMP) and/or the Pharmacovigilance Risk Assessment Committee (PRAC). It is designed to communicate clear information to patients, healthcare professionals and other stakeholders on shortages assessed by the EMA. For more information, see:
- Shortages catalogue
- Communication by the European Medicines Agency on supply shortages of medicinal products