The list with COVID-19 treatments that have been the subject of EMA's guidance
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.
Other extraordinary transparency measures in relation to COVID-19 treatments
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:
- The publication of the European Public Assessment Report (“EPAR”) within three days of the grant of a marketing authorisation. The standard practice is to publish the EPAR at least two weeks after the grant of the marketing authorisation.
- The publication of product information in English within one day of a positive opinion given by the Committee for Medicinal Products for Human Use. The standard practice is to publish the product information in all EU languages with the EPAR, therefore, at least two weeks after the grant of the marketing authorisation.
- Full publication of the Risk Management Plan (“RMP”). The standard practice is to only publish a summary of the RMP
Authored by Elisabethann Wright and Silvia López Arnao
