EMA offers free advice to COVID-19 vaccine and therapeutic developers

The European Medicines Agency (EMA) has released a statement saying it is providing full fee waivers for scientific advice given to developers of potential COVID-19 therapeutics or vaccines. The overall aim is to accelerate the approval of a safe and effective therapeutics to treat those infected with the coronavirus.

The EMA intends this service to identify products which are advanced enough to benefit from fast-track scientific advice, designed to give guidance on the best methods and study designs to generate the data required for drug approval.

According to the agency, it has already organised teleconferences with several developers and is working closely with other international regulatory bodies, while also keeping its member states apprised of all activities.

The EMA is supporting the World Health Organization’s (WHO’s) work to prioritise and analyse all available evidence regarding the efficacy and safety of repurposed agents and investigational agents currently under investigation. The priority is to develop a therapeutic for COVID-19.

According to the agency, this is due to vaccine development being at an early stage, with no existing vaccines able to be repurposed. In their statement, the EMA revealed that, while vaccine development timelines are hard to predict, it is estimated that the first COVID-19 clinical trails will not begin until after April/May 2020. As a result, it will take several months for these vaccines to be ready for larger clinical trials. Once they have sufficient information, the agency will assess any applications for marketing authorisation "within the shortest possible timelines."

This may include use of the PRIME scheme, accelerated assessment and/or conditional marketing authorisation procedures. Adequate demonstration of quality, safety and efficacy is expected in order to support the authorisation of COVID-19 medicinal products.

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