Medicine shortages: preparing the supply chain using EMA guidance

Preventing a medicine shortage means understanding the supply chain before it breaks down. In 2026 the European Medicines Agency (EMA) updated its guidance on shortage prevention plans, connecting product availability to the location of manufacturing sites, supplier dependencies and measures that can be taken when risks emerge.

From a document to a map of dependencies

The EMA guidance for marketing authorisation holders, first published on 7 August and updated on 31 August 2026, accompanies a plan template. The agency says holders must establish, maintain and update plans for prescription medicines and other products identified by the European Commission under the specified conditions. The legal implementation deadline is expected from mid-2027; companies should check how the rules apply to their own products.

The practical starting point is to make the sequence of production steps visible. The guidance calls for a map showing sites involved at each stage, their location, the share of production volume at each site and identified vulnerabilities and dependencies. A supply chain with several commercial names may still depend on the same plant: a supplier list alone will not necessarily reveal the actual exposure.

Finding bottlenecks

Examples in the EMA guidance include single-source suppliers, manufacturing sites without appropriate alternatives, long production or restart times, recurring delays and past quality problems. The guidance also asks companies to record the causes of previous shortages and the measures taken, according to the criteria in the document.

For a business, this calls for cooperation between purchasing, manufacturing, quality, regulatory affairs and planning. Assessing a second supplier should go beyond commercial availability: teams need to establish whether materials and processes are qualified, how much capacity is genuinely available and which approvals or changes may be required. This is an organisational assessment, not a guarantee that every alternative can be activated immediately.

Supply-chain risk and patient impact

The template separates the supply-chain assessment from the impact an interruption could have on patients and calls for an overall risk classification. The extent of documentation and the measures chosen should be proportionate to the identified risk. For medicines included on specified critical lists during a public health emergency or major event, the guidance also provides for additional information, including capacity and potential alternative sites.

A plan is useful only if kept current: a site change, a production transfer or a new bottleneck can make an earlier assessment obsolete. Defining responsibilities, review frequency and escalation thresholds before a disruption, and connecting the plan to quality procedures and communications with competent authorities, can help teams act on its findings.

Prevention and management are different stages

Prevention aims to reduce the likelihood and consequences of a shortage; management comes into play when a shortage is expected or already occurring. EMA recommends timely notification to authorities and communication throughout the supply chain. For more on changes and quality, read Economind’s pharmaceutical scale-up analysis.

Sources: EMA, guidance for companies on medicine availability; EMA, Guidance for industry on implementing Shortage Prevention Plans, EMA/160238/2026.

Illustrative photograph: COVIran Barekat vaccine production at the Shifa Pharmed facility, Iran, 2021. Photo Tehran Times / Wikimedia Commons, CC BY 4.0; source. The photograph does not depict a case analysed by EMA.

Article prepared with AI assistance and editorial verification of sources.