Posted by Michael Wonder on 20 Apr 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #2
20 April 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual meeting on 15 April to discuss the progress and implementation of the measures adopted to ensure the continued availability of medicines for European patients during the COVID-19 pandemic.
The Steering Group was informed that Member States and industry have welcomed the publication of the question-and-answer document that provides guidance to stakeholders on adaptations to the regulatory framework aimed at addressing challenges arising from the current pandemic. The European Commission, EMA and the Heads of Medicines Agencies are currently working on a first update of the Q&As that will comprise new provisions regarding good manufacturing practice as well as safety monitoring.
The measures deal with regulatory aspects such as the conduct of inspections, pharmacovigilance reporting as well as manufacture and import of medicines in the context of COVID-19. The update will be published soon. EU regulators are currently evaluating how these provisions would be applied to veterinary medicines.
