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).
In the European Union, most medicine shortages are dealt with at national level by the national competent authorities.
However, the 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.
European regulatory authorities aim 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.
The Agency maintains a catalogue of shortages that it has assessed.
EMA published a reflection paper in November 2012 concerning public health incidents that can arise due to manufacturing disruptions linked to problems such as quality defects or Good-manufacturing-practice (GMP) compliance issues. It concerns human medicines regardless of their route of authorisation, where there is an identified need to coordinate the assessment and any risk-reducing actions at EU level. An implementation plan was also drawn up, defining actions to co-ordinate the assessment of shortages, develop risk-minimisation measures, alleviate the impact on patients and communicate within the EU regulatory network:
- Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems
- Reflection paper on medicinal-product supply shortages caused by manufacturing/good-manufacturing-practice compliance problems - Implementation plan 2012-2015
A workshop on product shortages due to manufacturing and quality problems organised by EMA in October 2013 led to the creation of an inter-industry association taskforce with the objective of proposing solutions to prevent the root causes of shortages due to manufacturing and quality problems.
Based on the implementation plan and input gathered at the October 2013 workshop, EMA developed a set of documents to support medicines regulators involved in the EU-level coordination of shortage situations due to GMP non-compliance/quality defects:
- 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)
A stakeholder meeting on 9 October 2015 reviewed the progress made since the workshop in 2013 and discussed:
- ways to evaluate the impact of measures taken to prevent shortages;
- whether further measures are needed, and agree on next steps;
- communication issues around shortages, including communication between industry and regulators, across the supply chain and to the public.
EMA will publish a report following the meeting, including next steps and actions.
Public catalogue of shortages
In line with the implementation plan, the EMA has established a public catalogue of shortages 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. The framework for setting up the shortages catalogue is set out in the below document:
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