OPEN stands for Opening Procedures at EMA to Non-EU authorities and is an initiative launched by the European Medicines Agency (EMA) in 2020 during the COVID-19 pandemic.
One of its aims is to facilitate the sharing of scientific and regulatory expertise during the assessment of applications for initial authorisation and variation so that patients gain faster access to important new treatments.
Human medicinal products in the following drug groups/therapeutic areas can be considered for a review in the EMA OPEN framework:
- medicines for the treatment of antimicrobial resistance (antibiotics)
- medicines under the EMA's "Priority Medicines" (PRIME) programme
- medicines that address an unmet medical need
- medicines used in response to public health threats
With the EMA taking the lead role, Swissmedic has been involved in EMA OPEN from the outset.
The regulatory authorities in Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (PMDA), the Republic of Korea (MFDS) and the World Health Organization (WHO) are also participants in EMA OPEN.
As an OPEN partner – and like the other participating authorities – Swissmedic receives the applications from industry at the same time as the EMA (maximum difference of 30 calendar days (CD)). This allows Swissmedic to conduct its own independent, but parallel, review of these applications according to the EMA's procedural timelines (in the standard or accelerated procedure).
While the EMA and all participating authorities aim to decide on an application at the same time, they remain independent in their decision making.