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
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.
Product information and labelling (flexibility in the labelling and packaging requirements to facilitate the movement of medicinal products within the EU)