EMA Calls for Harmonized Definition of Medicine Shortages due to GMP Compliance Problems
January 29, 2016
The European Medicines Agency (EMA) has called for the establishment of a harmonized definition of a medicine shortage after meeting with the industry to discuss the development of proactive approaches to preventing shortages in supply due to GMP non- compliance/quality defects.
The European Medicines Agency (EMA) has called for the establishment of a harmonized definition of a medicine shortage after meeting with the industry to discuss the development of proactive approaches to preventing shortages in supply.
Officials at EMA left the meeting with a strong belief in the importance of harmonized, industry-wide terminology and a common understanding of how supply disruptions evolve. Almost two-thirds of member states lack a definition of a medicine shortage, and there is a little consensus about exactly what the term means, even among the countries that have put their interpretations of the phrase in writing. EMA thinks this lack of harmonization results in the conditions for reporting drug shortages varying across Europe, making it difficult to perform benchmarking and comparisons.
Despite these difficulties, EMA sees enough shared ground on which to build its strategy. “Although there is no harmonized approach to reporting and dealing with shortages, common points could be identified which could be built on to develop common best practices,” the regulator wrote. EMA is looking to start this process by identifying the point at which a manufacturing or quality problem is likely to trigger a significant disruption to supply. Once EMA has located this point, it intends to set a marker for when manufacturers should report a situation that could lead to a shortage.
However, while many member states are in favor of harmonization in some areas, notably shared reporting triggers and data requirements, there is resistance to the concept of all working from the same templates. The use of harmonized reporting templates is seen as overly rigid. Even without the harmonization of these forms, EMA thinks it can establish a system in which information gathering is consistent and responses to changes to the situation are coordinated. EMA plans to establish single points of contact at national and European levels to facilitate such coordinated responses.
The identification of ways in which EMA and member states can work collaboratively to improve the handling of shortages is set to lead to the revision of the agency’s implementation plan. Yet, while the various regulatory groups in Europe can go some way to refining the process, EMA is conscious of the need to involve the industry and its global peers. EMA plans to meet with overseas regulators to identify common points and differences, while also exchanging best practices. The work mirrors the activities EMA has undertaken to learn how approaches to shortages vary across Europe.