A European Union (EU) task force, which was set up by European regulators, has published its work programme for 2019/20 and announces a multi-stakeholder workshop.
EMA aims to improve the availability of medicines in Europe
Home/Policies & Legislation | Posted 12/10/2018 0 Post your comment
The task force was set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) with the aim of improving the availability of medicines in the EU. It includes representatives from the European Commission and interested national competent authorities, the chairs of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and Veterinary (CMDv), the GMP/GDP Inspectors Working Group, the Working Group of Communication Professionals (WGCP) and the European Surveillance Strategy Working Group (ESS WG).
Key priorities of the task force include:
- looking at ways to minimize supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework, e.g. using work sharing and reduced timetables when possible
- developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain, e.g. developing guidance for companies on reporting of shortages
- encouraging best practices within industry to prevent shortages
- improving sharing of information and best practices among EU regulatory authorities to better coordinate actions across the EU
- fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens.
The task force also announced that it will organize a multi-stakeholder workshop on 8−9 November 2018 to gather stakeholders’ perspectives on how to address availability issues and to include their input into the deliverables of the task force.
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Source: EMA, HMA
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