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6 keys to understand the new European clinical trials portal (CTIS)

Royal Decree 8/2020 has approved various and extraordinary measures, including authorization to the National Biotechnology Centre (CNB) to use any genetically modified organism (GMO) they believe appropriately to combat the SARS-CoV-2 (COVID-19) pandemic.

Sermes CRO covid-19

The idea is to create a new virus that has no capacity to replicate in the host cell and is neither harmful nor harmful to the recipient, but that acts as a vaccine against the coronavirus, producing an immune response that is able to defend individuals against a subsequent infection.

RD 8/2020 therefore authorizes the CNB to develop confined use activities with biosecurity level III, in particular the construction of recombinant viruses based on the coronavirus (COVID-19)genome.

For the confined use or voluntary release of a genetically modified organism, authorization by the Interministerial Council of Genetically Modified Organisms (CIOMG) is required, in this exceptional situation the streamlining of the procedures and deadlines for generating genetically modified coronavirus has been allowed. The President of the CIOMG may authorise the conduct of any voluntary release activity or use confined with GMOs, where it is intended or demonstrated useful in preventing, combating or containing the coronavirus epidemic caused by the SARS-CoV-2019 (COVID-19) virus.

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