EMA issues guidelines on shortage mitigation, prevention plans
On Monday, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued two guidelines offering more granular information on how drugmakers should implement shortage mitigation plans (SMPs) and shortage prevention plans (SPPs).In a related development, in late November, EMA told marketing authorization holders (MAHs) to “familiarize themselves” with the new European Shortages Monitoring Platform (ESMP) for reporting shortages of centrally authorized products. While voluntary now, such reporting will be mandatory on 2 February 2025.
Regulation (EU) 2022/123 of the European Parliament and Council, dated 25 January 2022, requires marketing authorization holders (MAHs) to implement shortage prevention and mitigation plans for critical medicines. It also called for the establishment of the ESMP.
Both the SMP and the SPP guidelines acknowledge that medicine shortages are a growing issue both in the EU and globally, and that the COVID-19 pandemic has only exacerbated this problem, affecting medications across all classes and increasingly impacting European countries.
These shortages “may have significant consequences for patient care, leading to medicine rationing and delays in critical treatments. Additionally, patients may be forced to use alternative medications, which could be less effective or increase the risk of medication errors due to a lack of familiarity with the new treatment regimen.”
Shortage mitigation plans
A shortage mitigation plan “formally identifies signals and risks for the continued availability of the product and implements a procedure for their mitigation.”
The guideline specifies that MAHs should establish procedures that outline the steps for managing a specific shortage, starting from the identification of the shortage to its resolution. These procedures should evaluate the impact of the shortage, notification to regulatory authorities, and follow-up actions. After resolving the shortage, a record of the root causes and the mitigation measures taken should be maintained.
The guideline says its essential to involve the high-level hierarchy of the company, specifically those with the authority and resources to address the identified deficiencies in the supply chain, in the development of the SMP.
SMPs must be submitted directly to Competent Authorities when MAHs become aware of a shortage.
The guidelines address how to implement an SMP, how to complete the SMP template, the information that should be submitted in the drug shortages reports, and whether any mitigating measures have been taken or planned by the MAH to address the shortage.
Shortage prevention plans
The shortage prevention plan is designed to identify potential risks in the supply chain and the impact on patients. The guideline advises companies to not consider the SPPs as an administrative document but rather as a “useful tool” to identify any potential risk of drug shortages.
The guideline further recommends involving the company’s “high-level hierarchy” in developing the SPP. This document should be part of the annual product quality review and updated on an annual basis. It should be in English and translated into the language of the Member State when requested by the NCA.
The information included in the SPP will be used only by Competent Authorities. Information will not be disclosed with third parties.”
The guidance addresses how to complete the SPP template; how to complete risk assessments, identifying the risk control strategies that are in place to minimize risks of shortages, and the methods for identifying medicines to be included in the Union list of critical medicines.
EMA announces new shortage reporting platform
EMA called the release of the ESMP a significant milestone in addressing medicine shortages and ensuring that medications are accessible to patients.
The ESMP aims to centralize and automate data collection on drug shortages, allowing regulators access to real-time data to prevent and better morning and manage drug shortages across the EU.
EMA said that a second version of the platform will be released in February 2025 “with the full scope of functionalities for MAHs and national competent authorities (NCAs). By then MAHs and NCAs will also be able to submit data on the supply, demand and availability of centrally and nationally authorised medicines during crises and preparedness actions led by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).”
The platform was developed to mitigate shortages of a subset of medicines, such as the shortage of antibiotics in 2023 and 2024. According to EMA, there are currently 30 drug shortages and cover a variety of medicines.
Guidance on shortage mitigation plans; Guidance on shortage prevention plans; EMA announcement on ESMP
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.