scoreqert.blogg.se - Ema problems

It is co-chaired by a senior national competent authorities representative appointed by HMA, and a senior EMA staff member.ĮMA and HMA agreed an updated structure for the Task Force in June 2022. The Task Force is composed of a steering committee and two thematic working groups, one focusing on medicine availability and supply disruptions and the other on communication.

fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens.

improving sharing of information and best practices among EU regulatory authorities to better coordinate actions across the EU.

encouraging best practices to prevent shortages.

developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain (for example developing guidance for companies on reporting of shortages).

looking at ways to minimise supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework (for example by work sharing and reduced timetables when possible).

More information on these is available below under 'Crisis preparedness and management'. In contrast, the structures and processes that EMA set up for dealing with medicine shortages in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123) are primarily focusing on activities related to crisis situations.

This aims to streamline processes, ensure synergies and avoid duplication of work within the network. the 'Joint Action on Shortages', a three-year plan starting at the end of 2022 to enhance national systems in tackling medicines shortages in a harmonised way.the European Commission's Pharmaceutical Strategy for Europe.

the European medicines agencies network strategy to 2025.It is designed to function as a ' supply and availability hub', tracking progress on the medicine availability and shortage-related activities that the European medicines regulatory network is undertaking under the following EU projects: It does not cover non-authorised medicines. The Task Force focuses on the availability of authorised human and veterinary medicines, irrespective of the authorisation route. The HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use is providing strategic and structural solutions to tackle disruptions in the supply of medicines and ensure their continued availability in the EU.