The European Medicines Agency (EMA) has issued recommendations to address supply chain vulnerabilities for critical medicines. Developed by the Medicines Shortages Steering Group (MSSG), these measures aim to ensure the availability and supply of essential human medicines. Key recommendations include:

  • Increasing manufacturing capacity and diversifying suppliers, such as by adding alternative manufacturing sites.
  • Monitoring supply and demand forecasts and stock levels throughout the supply chain.
  • Stockpiling medicines to safeguard against demand or supply fluctuations, involving marketing authorisation holders (MAHs) and the European Commission.
  • Requesting MAHs to create shortage prevention plans for critical medicines, with guidance and templates to be provided by June 2024.
  • Offering scientific and regulatory support, particularly for small and medium-sized enterprises, to mitigate supply chain vulnerabilities.
  • Utilizing work-sharing procedures and reliance on assessments by other recognized authorities, along with accelerated timelines for necessary variations.

These recommendations aim to strengthen the supply chain and ensure the consistent availability of critical medicines in the EU.1

You can read the full text here.

References

  1. New recommendations to strengthen supply chains of critical medicines | European Medicines Agency. (2024, April 23). https://www.ema.europa.eu/en/news/new-recommendations-strengthen-supply-chains-critical-medicines

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