Medicine shortages are becoming an increasingly important challenge for pharmaceutical companies across the EU, with potential consequences for continuity of supply, regulatory compliance and, most importantly, patient care. Supply chain vulnerabilities, manufacturing and quality issues, unexpected changes in demand or limited alternatives can all contribute to disruptions that may ultimately affect medicine availability.
For Marketing Authorisation Holders (MAHs), addressing drug shortages is no longer only about responding when a supply problem occurs. EMA’s updated Guidance for industry on implementing Shortage Prevention Plans (SPPs), published on 7 August 2026, reinforces the need to identify supply vulnerabilities early and put measures in place.
Preparing an effective Shortage Prevention Plan requires more than completing a regulatory template. Companies need to understand the applicable regulatory requirements, assess quality and supply-chain risks, consider the potential impact on patients and coordinate input from the relevant functions.. Experienced regulatory affairs consulting can help companies interpret evolving requirements and integrate them into a coordinated, cross-functional approach to shortage prevention. A well-prepared SPP can help MAHs identify vulnerabilities early, define appropriate preventive measures and build a more resilient approach to continuity of supply.
What should companies do to prepare for medicine shortages?
Pharmaceutical companies should start by establishing a structured, cross-functional process for identifying and assessing risks that could lead to medicine shortages. EMA emphasises that a Shortage Prevention Plan (SPP) should not be treated as an administrative document, but as a practical tool for identifying vulnerabilities and ensuring that preventive measures are in place.
The first step is to determine which medicinal products fall within scope and gather the information needed to understand their supply chains. Companies should assess factors such as the number and location of suppliers and manufacturing sites, dependency on third countries, manufacturing complexity, production and release lead times, previous quality defects or recalls, delays from critical suppliers, and the history and root causes of previous shortages. Based on these factors, the likelihood and potential impact of drug shortages should be evaluated and appropriate preventive measures defined.
SPP preparation should not sit with one department alone. Effective regulatory affairs input is important for interpreting applicable requirements and keeping the SPP aligned with regulatory expectations, while relevant information may sit across Quality, manufacturing, supply chain and Medical functions. Companies therefore need clear responsibilities and effective coordination between the teams involved in identifying vulnerabilities, assessing their potential consequences and defining appropriate actions. SPPs should also be integrated into existing quality processes rather than prepared as one-off documents. Companies should use established quality-management systems and review processes to monitor the effectiveness of their SPPs, identify the need for updates and maintain appropriate oversight. The SPP may also be considered within the Annual Product Quality Review, while relevant changes to the product or supply chain should trigger reassessment of the plan.
The priority for MAHs should therefore be to establish the necessary processes, responsibilities and cross-functional expertise now, rather than waiting until the new SPP requirements become legally applicable. EMA advises MAHs to ensure that they are ready to implement SPPs before the legal deadline, currently expected from mid-2027.
How can Billev Pharma East support Shortage Prevention Plan preparation?
Preparing a Shortage Prevention Plan requires more than regulatory knowledge alone. The information and expertise needed to identify and assess risks of medicine shortages often sit across Regulatory Affairs, Quality, manufacturing, supply chain and Medical functions. Bringing these perspectives together into one SPP can be challenging, particularly for companies with limited internal resources or complex product portfolios.
At Billev Pharma East, we support companies throughout the preparation, review and maintenance of Shortage Prevention Plans by combining Regulatory Affairs, Quality and Medical expertise within one multidisciplinary team. Our Regulatory Affairs experts help interpret applicable EMA and EU requirements and ensure that the SPP is structured in line with regulatory expectations. Our Quality specialists contribute expertise in pharmaceutical quality systems, manufacturing and supply-chain risks, while our Medical experts can support the assessment of the potential clinical impact of supply interruptions and the availability of therapeutic alternatives. This multidisciplinary model reflects Billev Pharma East’s broader integrated approach across Regulatory Affairs, Quality/GxP and Medical Consultancy.
Companies therefore do not need to coordinate SPP preparation across multiple external specialists.. We bring the relevant expertise together, identify gaps, coordinate the necessary assessments and support the development of an SPP that is compliant and practical for managing the risk of drug shortages.
Whether you need support developing SPPs from the ground up, reviewing existing plans against the new EMA guidance or strengthening the processes behind them, working with an experienced regulatory affairs consultant can help turn complex requirements into a structured, manageable and compliant process. At Billev Pharma East, we complement this regulatory expertise with in-house Quality and Medical knowledge to support the cross-functional nature of SPP preparation.
What should companies consider when preparing a Shortage Prevention Plan under EMA guidance?
The new EMA Guidance for industry on implementing Shortage Prevention Plans (SPPs) emphasises a risk-based and proportionate approach. The purpose of an SPP is not simply to document potential medicine shortages, but to identify vulnerabilities within the medicine supply chain and ensure that appropriate measures are in place to prevent, mitigate or manage the risks that could lead to supply disruption.
Under the new framework, MAHs are required to establish, maintain and keep SPPs up to date for prescription medicines, as well as for other medicinal products identified by the European Commission under specified conditions. Companies should therefore determine which products within their portfolio fall within scope and establish a process for preparing and maintaining SPPs across their portfolioSPP preparation requires an understanding of both the potential impact of a supply disruption on patients and the vulnerability of the supply chain. The assessment should consider factors such as the availability of therapeutic alternatives, market share, manufacturing and supply-chain complexity, dependency on individual suppliers or sites, manufacturing lead times, previous quality issues and the history and root causes of shortages. These elements are used to determine the overall risk level and the extent of shortage prevention measures required.
Importantly, EMA applies the principle of proportionality: the degree of effort, formalisation and documentation should correspond to the identified level of risk for each medicine. This means that SPP preparation should focus on meaningful risks and appropriate preventive measures rather than becoming a purely administrative exercise.
SPPs should be treated as living documents and updated as regulatory requirements, product characteristics and supply-chain conditions evolve.” An experienced regulatory affairs specialist can help ensure that these changes are appropriately assessed from a regulatory perspective and reflected in the SPP where necessary. Effective internal governance, access to reliable data and coordination between relevant functions remain essential for the long-term prevention of drug shortages.
How should companies assess the risk of medicine shortages?
EMA’s approach to Shortage Prevention Plans is based on assessing two key dimensions: the potential impact of a supply disruption on patients and the likelihood of a shortage occurring within the supply chain. Together, these determine whether the overall shortage risk for a medicinal product is classified as low, medium or high.
When assessing patient impact, companies should consider the therapeutic importance of the medicine, the availability of alternative medicinal products and the product’s position within the relevant market. A disruption involving a medicine for which suitable alternatives are limited may have more significant consequences than a disruption affecting a product with readily available alternatives.
The supply-chain assessment should then examine vulnerabilities that could increase the likelihood of medicine shortages. Relevant factors include the number and geographical location of manufacturing sites and suppliers, dependence on individual sources, manufacturing complexity and lead times, previous quality defects or recalls, critical supplier delays, identified bottlenecks and other product-specific supply risks.
These two assessments should be considered together. EMA’s methodology combines patient impact with the probability of supply disruption to establish the final risk classification. For example, a medicine with a high potential impact on patients may still receive a high overall risk classification even where the probability of a shortage is assessed as medium.
The resulting classification is important because it determines the expected level of detail and the shortage prevention measures that should be incorporated into the SPP. A higher risk of drug shortages requires more comprehensive prevention and risk-reduction measures.
What shortage prevention measures should companies include in an SPP?
Once the risk of medicine shortages has been assessed, companies should define measures to reduce the likelihood of supply disruption and strengthen the resilience of the medicine supply chain. The measures included in the Shortage Prevention Plan should be proportionate to the level and nature of the identified risk.
For low-risk medicines, a more streamlined approach to documenting shortage prevention measures may be appropriate, including reference to relevant company-level shortage prevention procedures. For medicines classified as medium or high risk, however, the SPP should provide more detailed information on the specific measures implemented to address identified vulnerabilities.
Depending on the risks involved, these measures may include increasing stock levels, diversifying suppliers, qualifying alternative manufacturing sites, increasing production capacity, reducing manufacturing and release lead times, improving demand forecasting or strengthening contractual arrangements with suppliers. Companies may also need to consider regulatory measures that could support continuity of supply, such as preparing variations to introduce alternative manufacturing sites or suppliers.
Preventive measures should be linked to the vulnerabilities identified during the supply-chain risk assessment. A generic list of actions is therefore not sufficient. The SPP should demonstrate how the selected measures address the specific factors that could contribute to drug shortages for the medicinal product concerned.
This makes the SPP a practical risk-management tool: identified risks should lead to defined preventive actions, clear responsibilities and ongoing monitoring of whether those measures remain effective.
How should companies maintain and update a Shortage Prevention Plan?
A Shortage Prevention Plan should not be treated as a one-off compliance document. Under the new framework, Marketing Authorisation Holders are expected to establish andmaintain up-to-date SPPs, ensuring that they continue to reflect the actual risks associated with the medicinal product and its supply chain.
Companies should therefore establish clear internal responsibilities for reviewing the SPP and monitoring whether the identified risks and preventive measures remain relevant. Where internal resources or specialist regulatory expertise are limited, regulatory outsourcing can provide additional capacity to support ongoing SPP review and maintenance while allowing internal teams to retain oversight of key decisions. Changes to manufacturing sites, suppliers, production processes, supply arrangements or other factors affecting continuity of supply may require the underlying risk assessment and corresponding measures to be reconsidered.
SPP maintenance should also be integrated into existing pharmaceutical quality processes. EMA recommends using established quality-management systems and review processes to monitor the effectiveness of SPPs, inform necessary updates and maintain appropriate oversight. This can help companies integrate the prevention of medicine shortages into existing operations rather than managing SPPs as a separate regulatory exercise.
Strong governance is equally important. EMA recommends that senior management or another appropriate high-level governance body maintains oversight of SPP development, implementation and updates. This is particularly relevant because preventing drug shortages may require decisions and resources across Regulatory Affairs, Quality, manufacturing, supply chain and Medical functions.
An effective SPP should evolve with the product, its supply chain and the regulatory environment. Keeping track of relevant regulatory updates can help companies identify new or evolving requirements that may affect their shortage prevention processes and determine whether existing procedures or documentation need to be reviewed. Keeping the SPP current also helps companies to identify emerging vulnerabilities earlier and address them before they lead to supply disruptions.
What is the difference between a Shortage Prevention Plan and a Shortage Mitigation Plan?
Although Shortage Prevention Plans (SPPs) and Shortage Mitigation Plans (SMPs) both contribute to managing medicine shortages, they serve different purposes.
An SPP is primarily preventive. It is designed to identify vulnerabilities within the medicine supply chain, assess the likelihood and potential impact of supply disruption, and establish measures that can prevent, mitigate or manage risks before they result in a shortage.
A Shortage Mitigation Plan becomes relevant when a shortage is anticipated or already occurring. EMA describes SMPs as plans outlining the measures taken by MAHs to reduce the impact of an actual or anticipated shortage on patients and healthcare systems.
The distinction is important because effective management of drug shortages should begin well before supply is interrupted. An SPP asks where vulnerabilities exist and what can be done to reduce the likelihood of a shortage. An SMP focuses on what actions should be taken when a specific supply problem is expected or has already materialised.
Companies should therefore consider prevention and mitigation as connected but distinct parts of their overall approach to medicine availability. A well-developed SPP can help identify and address vulnerabilities early, while an SMP provides a structured response when preventive measures alone are no longer sufficient.
Together, these tools support a more proactive and structured approach to maintaining medicine availability and protecting continuity of supply.
Get expert support with Shortage Prevention Plan preparation
The new EMA guidance makes proactive preparation increasingly important for companies seeking to strengthen their approach to medicine shortages. Effective SPP preparation requires a structured process that connects regulatory requirements, quality and manufacturing considerations, supply-chain vulnerabilities and the potential impact of disruptions on patients.
Starting early can help MAHs identify gaps, establish clear responsibilities and implement appropriate preventive measures before identified vulnerabilities result in drug shortages.
At Billev Pharma East, we bring Regulatory Affairs, Quality and Medical expertise together to support the preparation, review and maintenance of Shortage Prevention Plans. Whether you are establishing your SPP framework, reviewing existing plans against the new EMA guidance or need additional cross-functional expertise, develop and maintain SPPs that reflect the specific risks within your portfolio and supply chain.
Sources: 1 – European Medicines Agency (EMA). Guidance for industry on implementing Shortage Prevention Plans (SPP). EMA/160238/2026, 2 – European Medicines Agency (EMA). Medicine shortages and availability issues: guidance for companies. EMA, updated 2026, 3 – European Parliament and Council of the European Union. Regulation (EU) 2022/123