EMA has launched a new OPEN pilot to increase international cooperation in evaluating COVID-19 vaccines and drug therapies. The project started in December 2020.
The aim of cooperation between non-EU authorities and certain international organisations is to accelerate the development and evaluation of COVID-19 medicines, as the needs for treatments and vaccines are the same globally. Non-EU competent authorities will bring additional expertise to the EU surveillance network and the project may in turn benefit the non-EU countries by expediting applications assessments and access to Covid-19 medicines.
Regulators from Australia, Canada, Japan, Switzerland and the World Health Organization (WHO) are participating in the pilot under the terms of existing confidentiality arrangements.