News about GMP/cGMP

The continuous supply of human and veterinary medicines across Europe shall be improved. Key priorities of the task force include:

• facilitating approval and marketing of medicines using the existing regulatory framework (e.g. using work sharing and reduced timetables when possible)
• 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.

Furthermore, 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. 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.

By the end of 2018 actions are agreed, e.g. on developing a metric to “measure” shortages, setting up an extra website for the programme or to develop guidance for companies on reporting of shortages.

Three thematic working groups on marketing authorisation, on supply disruptions and on communication have now taken up work to fulfil the plan by the end of 2020.

Source:

EMA: Press Release

EMA/HMA: Work Programme