The European Medicines Agency (EMA) has outlined the tools it will use to expedite the development and approval of medicines and vaccines for COVID-19.
“Supporting the development and marketing authorisation of safe, effective and high-quality therapeutics and vaccines as soon as possible is one of EMA’s top priorities in the COVID-19 public health emergency.”
The COVID-19 EMA pandemic Task Force (COVID-ETF) coordinates and enables rapid regulatory development, authorisation and safety monitoring of treatments and vaccines intended for use against COVID-19. Formal rapid procedures have been established for these support and evaluation activities, and are available for products intended for prevention or treatment of COVID-19, including both new products and products already authorised in other conditions. These include:
- Rapid scientific advice
- Rapid agreement of a paediatric investigation plan and rapid compliance check
- Rolling review
- Accelerated assessment of marketing authorisation applications.
- Extension of indication and extension of marketing authorisation
- Compassionate Use
- Other considerations
“Rapid approval of therapeutics and vaccines will only be possible if applications are supported by robust and sound scientific evidence.”
Recently, the EMA commenced a rolling review of the antiviral drug remdesivir and also recommended expanding the compassionate use programme for remdesivir to patients not on mechanical ventilation, based on results from two recent clinical studies.
For more information on the EMA initiatives for acceleration of development, support and evaluation procedures for COVID-19 therapeutics, click here.