EMA Confirms Standards for COVID-19 Treatment Evaluations

The European Medicines Agency (EMA) sent an open letter to European Ombudsman Emily O’Reilly, dated Sept. 30, 2020, detailing the agency’s transparency plans for COVID-19 treatments and affirming its commitment to independence in the evaluation of COVID-19 treatments and vaccines. The letter was in response to the Ombudsman’s request for more information on the agency’s pandemic task force (COVID-ETF).

The COVID-ETF was established to take a coordinated approach to the COVID-19 pandemic. It provides guidance on the development of COVID-19 treatments; it reviews and requests data from developers; and it works as an advisor to the Scientific Advice Working Party (SAWP)/Committee for Medicinal Products for Human Use (CHMP).

In the letter, the agency details steps to ensure a separation between persons giving scientific advice to a drug developer and persons evaluating a market authorization application. The letter states, “In accordance with its mandate, no member of the COVID-ETF exercises a leading or prominent role in the pre-submission phase. The COVID-ETF works in collegial manner with shared responsibilities, while the prominent roles are reserved for the Coordinators in the SAWP and the CHMP Rapporteurs.”

In a press release, EMA stated that it will be publishing clinical data supporting its recommendations for COVID-19 treatments. The agency had suspended its policy to publish clinical data because of EMA’s move from the United Kingdom to the Netherlands, but it is reinstating the policy exclusively for COVID-19 medicines. The agency also affirmed in the letter that it will be providing a log of all relevant pre-submission activities for COVID-19 medicines.

Source: EMA​