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EU regulators published their work programme for 2019/20

03 September 2018

GMP News

The task force set up by European Union (EU) regulators to better address potential problems with medicines’ supply and to avoid shortages published its work programme for the coming two years.

Improving the availability of human and veterinary medicines authorised in the EU is a key priority of the EU Network. The work programme lists actions for regulators and industry alike to ensure the availability of medicines for the benefit of patients in the EU.

The task force has been set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), with 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).

The task force will develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe.

Key priorities of the task force include:

  • looking at ways to minimise 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 will organise 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. It will bring together all stakeholders impacted, including patients, consumers, healthcare professionals, industry, wholesalers/distributors, parallel distributors, academia and regulators.

The withdrawal of the United Kingdom from the EU is also likely to affect the availability of medicines in the EU. In this context, the task force provides a platform to facilitate and coordinate actions between Member States, EMA and the European Commission.


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