EMA Guidance for medicine developers and companies on COVID-19

EMA Guidance for medicine developers and companies on COVID-19

The European Medicines Agency (EMA) released a guidance for medicine developers and pharmaceutical companies to help speed up medicine and vaccine development and approval for COVID-19, and on how they should address the regulatory challenges arising from the COVID-19 pandemic.

The overall aim is to accelerate and simplify the procedures for the development of COVID-19 treatments and vaccines, providing a guide in every step of the regulatory pathway as well as ensuring that robust evidence on efficacy, safety and quality is generated to support scientific and regulatory decisions.

EMA encourages the scientific community and companies to join the efforts in this sense and invite them to contact EMA as soon as possible to discuss their strategy for evidence-generation.

The guideline is available at this link.

2020-06-15T16:53:38+00:00 15/06/2020|Categories: News & Events|