The European Medicines Agency has published a plan to help Europe’s regulatory network prevent, mitigate, and manage shortages of important medicines following manufacturing problems.
Shortages of medicines arising from unforeseen disruptions within manufacturing processes, such as GMP compliance issues, have increased in recent years. However, experience from these shortages has enabled the EMA to identify several short- and medium-term actions that will help to deal with future occurrences. These actions are outlined in the EMA’s reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice Compliance problems.
Some of the actions being taken in the short term include, among others:
- Creating a public catalogue of current shortages
- Establishing standard operating procedures for handling reports of shortages
- Develop international cooperation to enable information sharing for specific shortages and on best practices on risk management and prevention strategies
- Raise the awareness of the impact of medicine shortages and stimulate industry reaction and improvements.
In the medium term, the EMA hopes to:
- Facilitate risk–benefit evaluation where risk shortage has to be balanced with potential risk because of the presence of a product defect.
- Require all marketing authorization holders to submit a risk analysis of their manufacturing processes to identify weaknesses, and contingency plans to strengthen these points.
- Investigate processes that could be used to measure the impact of medicines in patients.
- Promote better and proactive risk management by marketing authorization holders.
According to EMA, several trends have converged to increase the number of medicines’ shortage. One of the major contributing factors is the globalization of supply chains and manufacturing networks.