Regulatory Focus™ > News Articles > 2020 > 3 > EMA Offers Free Scientific Advice for COVID-19 Developers

EMA Offers Free Scientific Advice for COVID-19 Developers

Posted 13 March 2020 | By Michael Mezher 

EMA Offers Free Scientific Advice for COVID-19 Developers

The European Medicines Agency (EMA) on Friday said it will fully waive fees for scientific advice to drugmakers developing potential treatments or vaccines for the novel coronavirus disease (COVID-19).
EMA typically charges fees ranging from €43,700-€87,600 ($48,430-$97,080) for scientific advice, though small- and medium-sized entities and orphan product developers are eligible for reduced fees.
EMA says companies should contact it “as soon as possible with information about their proposed development” and provides a dedicated email for inquiries.
“In a first round of discussions, EMA can provide preliminary informal comments and feedback on development. This will then allow the agency to identify products which are mature enough to benefit from fast-track scientific advice, to guarantee best use of this too,” EMA says, noting it is supporting the World Health Organization’s (WHO) activities to prioritize research for the disease.
EMA says its priority will be accelerating the development of new or repurposed products to treat people infected with COVID-19.
While EMA says it will assess applications for vaccines “within the shortest possible timelines,” the agency cautions that there are no existing vaccines that can be repurposed for coronavirus and that novel vaccines are still in early stages of development.
EMA also points to its existing expedited development programs, including its Priority Medicines (PRIME) scheme, accelerated assessment and conditional marketing authorization procedures.


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.