REGULATORY CHALLENGES TO TACKLE SHORTAGE OF MEDICINAL PRODUCT FOR MARKET AUTHORIZATION HOLDERS IN EU Authors: Spoorthi H S , DHARANI R K, UDAYARANGA K A AND ABHISHEK B V*
ABSTRACT
A "shortage" is defined as a disruption in the supply of a medicinal ingredient, and it is a worldwide
issue. The study's main goal is to gather and publish information regarding drug shortages in
European nations. This study covered countries like Belgium, the Netherlands, England, Italy,
France, Germany, and Spain that had medicine shortage reporting systems. Information was
gathered from publicly accessible internet reporting systems regarding the attributes of the drugs
that are in limited supply as well as the reasons for the shortage. There were descriptive analyses
carried out. Oral, branded medications that target various disease domains might be classified as
drug shortages that are taken into account by the reporting systems under consideration. Generic
injectables are more complex when critical medications and cancer treatments are taken into
account. The reasons behind medicine shortages are not well acknowledged. If the reason is known,production issues come first. Medicine shortages have an impact on patient care and healthcare
services. For shortages to be effectively managed, there must be greater openness and information
availability about current and upcoming shortages, as well as improved healthcare professional
readiness. Across the globe, concerns about medication shortages are growing. Authorities in the
European Union (EU) have started a number of initiatives to address this significant public health
concern. Vaccines Europe (VE), a group that represents 14 European vaccine firms, carried out an
analysis of the primary reasons of vaccine shortages in Europe in order to aid in the search for
solutions. Six primary causes of vaccine shortages have been identified by Vaccines Europe. It
will take a coordinated effort and communication with all important players to find solutions.
Keywords: Drug shortage, Drug supply, Health policy Publication date: 01/01/2026 https://ijbpas.com/pdf/2026/January/MS_IJBPAS_2026_9740.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2026/15.1.9740