EMA Issues Two Guidances on Drug Shortages
Posted 05 July 2019 | By
The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) on Friday issued two guidance documents providing instructions to drugmakers on detecting drug shortages and notifying regulators of shortages as well as instructions to regulators for communicating about drug shortages to the public.
The guidance documents were developed by a European Union task force assembled to tackle issues related to medicines supply as part of an effort to better prevent, identify and manage drug shortages.
"Shortages and availability problems are complex with no quick solutions. Medicine regulatory authorities are only one of the many actors involved in availability issues, however the play an important role in prevention and management," EMA writes.
The first guidance
sets out to define drug shortages and explain what issues related to drug supply should be reported. The guidance also details who is responsible for monitoring and reporting shortages, when notifications to regulators are required and what information should be included in those notifications.
According to the guidance, "a shortage of a medicinal product for human or veterinary use occurs when supply does not meet demand at a national level."
"Logistic-related issues leading to regional supply disruption of a medicinal product e.g. delivery difficulties, national redistribution of stock, are a short term and localised problem and should not be taken into account," the guidance states.
The guidance also stresses that shortage notifications for all products must be sent to the impacted competent authorities. Notifications concerning centrally authorized products should be sent to EMA as well as the national regulators in the countries where the shortage is occurring or anticipated.
When sending a notification, the guidance specifies that the information should be "as accurate and up-to-date as possible while being comprehensive and concise."
The guidance includes a proposed template for drugmakers to use when a reporting template is not available at the national level.
In the guidance on communicating drug shortages to the public
, EMA and HMA say that "communication practices vary amongst member states and there is a need to review and consolidate existing practices into a single document."
The goal of the guidance, according to EMA and HMA is to improve current communication practices, align the criteria for publishing shortage notifications across the EU and increasing the visibility and accessibility of information on drug shortages.