
Trump Administration Executive Order (EO) Tracker
On 30 October 2020, the European Medicines Agency (“EMA”) published a list containing all COVID-19 treatments and vaccines that have so far been the subject of scientific advice or informal guidance from EMA’s pandemic Task Force. This initiative is part of the EMA’s efforts to implement extra transparency measures in relation to the review of COVID-19 medicinal products. The EMA will update this list on a monthly basis.
The list includes medicinal products that have been the subject of scientific advice or informal guidance from the EMA’s pandemic task force. This guidance provided by the EMA is intended to help medicinal product developers to prepare for an eventual marketing authorisation application in relation to their COVID-19 treatments. The guidance can cover the best methods and study designs for generating robust data concerning safety and effectiveness of medicinal products. It can also provide information on quality aspects, such as manufacturing and testing, or on laboratory studies. The EMA provides this guidance at no cost. The outcome of any consultation or advice from EMA is not binding on developers.
The list of the COVID-19 treatments that have been the subject of EMA guidance includes information concerning the stage of development of the medicinal product when the EMA gave its guidance. It also includes information on the developer of the treatment and the type of medicinal product in respect of which the guidance was provided. These include, among others, vaccines, antivirals, and immunomodulators.
The EMA will update this list on a monthly basis.
The publication of this list is part of the EMA’s commitment to maximise the transparency of its regulatory activities in relation to COVID-19 treatments and vaccines. Since the start of the pandemic, the EMA has implemented exceptional measures in this regard.
The transparency measures are intended to address the high level of interest in information concerning and support of global research on COVID-19 medicinal products. The measures are in addition to the information that the EMA normally publishes in relation to human medicinal products.
Other exceptional transparency measures undertaken by the EMA include:
Authored by Elisabethann Wright and Silvia López Arnao