New EU Task Force Unveils Two-Year Regulatory Roadmap to Mitigate Medicine Shortages
Regulatory authorities in the European Union (EU) have set up a task force to improve the availability of medicines by mitigating potential shortages based on a two-year roadmap published on Wednesday.The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) organized the task force to achieve five main objectives. These include facilitating the approvals of medicines in the EU, developing strategies for shortages caused by supply chain disruptions, promoting best practices for shortage prevention and improving information-sharing among regulatory authorities.
The fifth priority relates to strengthening the line of communication about issues in the supply of medicines to EU citizens and encouraging greater collaboration among stakeholders. A public workshop will be held on 8-9 November to obtain stakeholder feedback on the task force’s work items.
The task force, which includes representatives of the European Commission, certain national competent authorities and several regulatory working groups, is charged with fulfilling the actions that were agreed upon last February for implementation within specified timeframes from 2019 through 2020.
It consists of a steering committee and three working groups focused on the areas of marketing clearances, supply chain disruptions and communication. The only action that has been completed so far involves joint evaluations on applications for generics and biosimilars, according to HMA-EMA work program.
Actions set to be implemented by Q4 include identifying the potential impact on the supply of EU medicines post-Brexit, setting an EU-wide definition for the term “medicine shortage,” developing industry guidance on reporting shortages and creating a metric for measuring shortages, among others.
EMA updated two guidance documents in June to aid pharmaceutical companies in compliance with EU requirements following the March 2019 Brexit cutoff date. The new work plan for medicine shortages will be updated “as required taking into account any new developments and especially the agency’s business continuity plans in the context of UK’s withdrawal from the EU,” HMA-EMA added.