As part of its health threat plan activated to fight COVID-19, the Agency has finalised and published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF), which 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. The task force is accountable to EMA’s human medicines committee (CHMP) for all its activities. Strict rules are in place to assure the independence of all members.
The COVID-ETF is chaired by EMA and composed of the chair and vice-chair of the CHMP, the Agency’s safety committee (PRAC), the Paediatric Committee (PDCO) and relevant working parties, as well as the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and the Clinical Trials Facilitation and Coordination Group (CTFG). It will include CHMP rapporteurs and co-rapporteurs for all COVID-19 medicines and vaccines, as well as additional experts as needed, including those involved in the review of applications received at national level. Additional observers will be invited on a case-by-case basis...
Full text GMPnews.Net