EMA outlines regulatory transparency measures amid COVID pandemic

Regulatory NewsRegulatory News | 30 October 2020 |  By 

Reflecting the extraordinary circumstances of the pandemic, the European Medicines Agency (EMA) announced that the agency is speeding announcements regarding the progress of clinical trials of vaccines and therapeutics for COVID-19. The agency is also making public certain information about the progress of clinical trials that would not ordinarily be published.
To clarify how it is addressing transparency for COVID-19-related medicines, EMA published a table listing nine regulatory procedures and contrasting standard EMA practice with practices that increase transparency and speed public announcements about the regulatory progress of COVID-19 therapeutics and vaccines.
Perhaps the most notable departure from business as usual is publication of full deidentified clinical trial data for COVID therapeutics and vaccines after they receive marketing authorization, a move EMA had announced in September (RELATED: EMA to require clinical data publication for COVID-19 related products, Regulatory Focus 16 September 2020)
These data are currently not published in any format by EMA for other medicine since the requirement for publication of clinical study reported has been suspended during the transition of EMA headquarters to Amsterdam from London as the UK prepares to depart the EU.
In a 29 October letter announcing the transparency measures, EMA Executive Director Guido Rasi said, “[W]e will publish all clinical data submitted to EMA in applications for COVID-19 medicines, once personal data have been anonymized and any commercially confidential information redacted in accordance with EU legislation.”
Earlier in the year, EMA had responded to calls from the Cochrane Collaboration and Germany’s Institute for Quality and Efficiency in Health Care (IQWIG) for such clinical trial data transparency with the response that the agency was discussing “how to enhance the level of transparency for COVID-19 procedures, including the possibility of rapidly publishing clinical data for these products.” (RELATED: EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication, Regulatory Focus 01 June 2020)
The enhanced transparency begins at the scientific advice stage, where ordinarily no information is published about which sponsors are requesting advice. By contrast, EMA has published a list of COVID-19 medicines for which scientific advice has been sought.
For COVID-19 medicines, compassionate use opinions are published no more than 1 day after the opinion has been reached and are accompanied by a news announcement. Marketing authorization applications receive similar treatment; they are announced within a day of EMA’s receipt of the application.
Rolling review of COVID-19 vaccine candidates is underway in the EU; EMA is announcing these reviews by the day after they are begun. There is no comparable mechanism for non-COVID medicines. “With the rolling review, developers can submit data from finalized studies as and when they become available, allowing EMA to start evaluating data at an earlier stage and before the developer submits a formal application,” said Rasi. “The result is a swifter review of data with no change to the robustness of the evaluation.”
Product information would usually be published in all EU languages with the European Public Assessment Report (EPAR); for COVID medicines, that information is made available in English within one day of a positive opinion. The EPAR itself is published within 3 days of issuance of marketing authorization, rather than two or more weeks after the authorization, as is standard practice.
Risk management plans are usually only published in summary form, but for COVID vaccines the full plan will be published. Also, any applications for extension of indications for use of medicines will be publicized with a news announcement within a day of the application’s filing.
In addition to enhanced transparency in data sharing, EMA is also boosting stakeholder engagement by bringing patients and health care professionals to the table at EMA’s COVID-19 Pandemic Task Force, said Rasi.


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Tags: coronavirus, EMA

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