New EU/EMA planned Actions in the Context of the COVID-19 Pandemic

The European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the COVID-19 pandemic.

Task Force to take quick and coordinated regulatory action related to COVID-19 medicines

EMA has finalised and published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF).  This Task Force assists Member States and the European Commission in dealing with development, authorisation and safety monitoring of therapeutics and vaccines intended for treatment or prevention of COVID-19. The main purpose of the COVID-ETF is to draw on the expertise of the European medicines regulatory network and ensure a fast and coordinated response to the COVID-19 pandemic.

Update on EU actions to support availability of medicines during COVID-19 pandemic

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events met virtually on 8 April to discuss ongoing activities aimed at ensuring a coordinated response to the challenges posed by the COVID-19 pandemic. Current activities are:

  • Set-up of i-SPOC (industry single point of contact) system. Through the i-SPOC system pharmaceutical companies can report directly to the Agency any issues related to the availability of crucial medicines being used in the context of COVID-19.
  • Compiling a list of the medicines currently being employed across the EU to treat patients with COVID-19.
  • Discuss the need to allow regulatory requirements pertaining to medicines to be applied more flexibly during the COVID-19 crisis. EU authorities are developing a question-and-answer (Q&A) document to provide guidance to stakeholders on areas where additional regulatory flexibility is possible (see below).
  • Possible Update to the Guidance on the management of clinical trials during the COVID-19 pandemic.

Guidance on regulatory requirements in the context of the COVID-19 pandemic

The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders? on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic.
Currently the document is focusing on the following areas:

  • Issues related to marketing authorisations and marketing authorisation procedures
  • Manufacturing and importation of finished products and active pharmaceutical ingredients, like, for example, how changes in the manufacturing/supply chain can be implemented swiftly to ensure continuity of supplies to the EU of crucial medicines.
  • Quality Variations
  • Product information and labelling (flexibility in the labelling and packaging requirements to facilitate the movement of medicinal products within the EU)