News about GMP/cGMP

05.02.2021

EMA: Pilot Project "OPEN" to Collaborate with Non-EU Authorities During COVID-19

EMA: Pilot Project "OPEN" to Collaborate with Non-EU Authorities During COVID-19

The European Medicines Agency (EMA) has launched an initiative to collaborate with non-EU authorities and WHO to drive the evaluation processes for COVID-19 vaccines and therapeutics.


The pilot program with the descriptive name "OPEN" was launched in December 2020. It will allow Health Canada, Japan's MHLW/PDMA, Swissmedic, Australia's TGA and WHO to participate in the Emergency Task Force (EFT) and Committee for Medicinal Products for Human Use (CHMP) assessment processes.  

The goal is to enable active international exchange on scientific evaluation and to provide for a better understanding of regulatory outcomes, while ensuring scientific and regulatory independence of the authorities involved. The project also serves to increase overall transparency and harmonization. This, the EMA states, should increase public confidence as regulatory decisions can be subjected to peer review. Project "OPEN" is time-limited to the duration of the COVID pandemic.  

In this regard, EMA published the four-page document "Questions and Answers on the Pilot Project 'OPEN'" on February 3, 2021. Eight pairs of questions and answers explain the conditions for participation and the required contents of the necessary documents.


Source:

EMA: Questions and Answers on the Pilot Project 'OPEN' 


 

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