Updates from the EMA
The European Commission and the Head of Medicines Agencies (EMA) support the development and approval of vaccines and treatments for COVID-19 under its recently activated plan for managing emerging health threat.
Consult EMA's special coronavirus disease (COVID-19) website for frequent updates.
Today, we would like to highlight the following EMA updates:
- EU PAS Register for 'COVID-19' studies
27 March 2020: Researchers are encouraged to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the EU PAS Register, including a study protocol and description of the collected data. 'COVID-19' should be included in the title to allow easy retrieval by others.
- Version 2 available of Guidelines for the management of clinical trials during COVID-19
27 March 2020: The EMA's guidelines for the management of clinical trials during the COVID 19 pandemic (pdf) was updated and now also includes:
- safety reporting
- distribution of in-vitro diagnostics
- medical devices
- auditing
- informed consent
See also joint guidance document from swissethics and Swissmedic, with input from SCTO network.
- Guidance on methodological aspects of ongoing clinical trials during COVID-19
25 March 2020: EMA published guidance to help ensure the integrity of their studies and the interpretation of study results while safeguarding the safety of trial participants as a first priority. This Guidance on methodological aspects of ongoing clinical trials during COVID-19 complements the above highlighted guidelines for the management of clinical studies during COVID-19.
Postponement of the MDR application intended to allow focus on urgent COVID-19 priorities
25 March 2020: Application of the new European Medical Device Directive is planned for the end of May 20. The European Commission has now announced that it is working on a proposal to postpone the date of application by another year. The Commission intends to submit the proposal to the Parliament at the beginning of April. A postponement would relieve pressure from national authorities, notified bodies, manufacturers, and other stakeholders and allow them to concentrate fully on the urgent priorities related to the coronavirus crisis.
Commission working on proposal to postpone MDR application date for one year (pdf)
Call for Expression of Interest for Sponsors and CRO
Until April 19, CEPI is seeking to identify entities that could serve as sponsors or provide clinical research organisation (CRO) support for clinical trials of COVID-19 vaccines.
More details can be found in CEPI's call for Expression of Interest (pdf).
Recommended reading:
Science magazine overview on the most promising coronavirus treatments being tested in mega trials
27 March 2020: The World Health Organization (WHO) announced a large global trial, called SOLIDARITY, to test four existing treatments on their potential for drug repurposing to treat COVID-19.
Read the full Science magazine article WHO launches global megatrial of the four most promising coronavirus treatments.