EMA, HMA recommend steps to address potential radiopharmaceuticals shortages
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have proposed actions stakeholders can take to mitigate potential shortages of radiopharmaceutical drugs. Among the recommendations, the regulators have asked stakeholders to monitor supply chains and evaluate transportation needs.On 14 April, EMA published a document about the state of the radiopharmaceuticals supply chain in Europe and steps to prevent their shortages. The drugs are used to diagnose and treat diseases such as cancer. While their use is growing in the economic zone, they tend to be imported and are vulnerable to shortages.
“Production of radiopharmaceuticals is reliant on stable isotopes and other materials that are sourced mainly from third countries,” said EMA. “In addition, the supply chain of these medicines, including how to transport them safely, is complex.”
EMA has listed recommendations that the European Commission, member states, manufacturers and itself can take to mitigate a potential radiopharmaceutical shortage. One recommendation is to develop means of increasing the production of radiopharmaceuticals inside the European Union while also improving aging infrastructures and enhancing production facilities, such as nuclear reactors in Europe.
Another key consideration is to address the complex challenges of transporting radioactive materials by harmonizing certification procedures and standards across countries.
“Consider transport challenges and EU level solutions to address these challenges in cooperation with Member States,” EMA told the Commission. “This could include harmonization of certification procedures and mutual recognition of transport containers among Member States, transport logistical challenges or potential challenges and consequences of ban of lead.”
Similarly, EMA said member states should also consider transportation challenges at the national level and develop solutions they can coordinate at the national and union levels.
An overarching recommendation is that member states should map their radiopharmaceutical supply chains, coordinate transport solutions, and monitor new radiopharmaceuticals coming to market.
While EMA notes that the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) has been monitoring the radiopharmaceuticals sector for potential shortages and providing regulatory support, it’s not enough.
“However, regulatory tools cannot address all the vulnerabilities identified in the supply chain, something which will also require long-term industrial policy measures, such as those in the Critical Medicines Act,” said EMA. “Enhanced security of supply, especially for medicines included in the Union list of critical medicines, is a priority within the EU.”
“Actions like these recommendations anticipate the implementation of the EU pharmaceutical legislation, in line with the 2023 Commission Communication on Addressing medicine shortages in the EU,” the agency added.
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