EMA Confirms Standards for COVID-19 Treatment Evaluations
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.
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
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