Due to the current COVID-19 pandemic, EMA has taken lots of initiatives (EMA/213341/2020) to accelerate the development support and evaluation procedures for COVID-19 treatments and vaccines.
These measures concern the following aspects:
- Rapid Scientific Advice, which leads developers to a prompt guidance on the best methods and study design to generate adequate data on medicine and vaccines.
- Rapid agreement of Paediatric Investigation Plan (PIP), which offers to establish a rapid and flexible approach for a PIP, deferral or waiver for treatments and vaccines for COVID-19.
- Rolling Review, which is an ad hoc procedure used in an emergency context to allow EMA to continuously assess the data for an upcoming highly promising application as they become available.
- Marketing Authorisation to encourage applicants to contact EMA early in the product development to discuss scientific and regulatory aspects of their planned application for the prevention or treatment of COVID-19.
- Extension of indication and of marketing authorisation to encourage Marketing Authorisation Holders (MAH) to share early information about their planned development for already authorised products for the treatment or prevention of COVID-19.
- Compassionate use programme in order to facilitate the availability to patients of new COVID-19 treatment or prevention options that are under development.
Regulatory Pharma Net team is available to support companies through all these procedures.