Born with the aim of harmonising the application, evaluation, and supervision process of clinical trials conducted in EU countries, there is much room for improvement for the Clinical Trial Information System CTIS, particularly with regard to SMEs and translational researchers.
A long-awaited draft regulation from the EU Commission’s DG Sante to deregulate the authorisation, risk assessment and labelling of a whole range of new genetically modified organisms (GMOs) has been published today by the College of the Commission. New Genomic Techniques (NGT) are introduced as an umbrella term for certain genetic engineering techniques that aim to modify DNA more precisely than "old" methods by targeting changes to pre-defined loci in the genome. The proposal creates two distinct pathways for NGT plants to be placed on the market. "Category 1 NGTs" are considered equivalent to conventionally bred plants and no longer require prior case-by-case risk assessment.
A new platform is set to facilitate the exchange of information on the optimisation of the electronic reporting system CTIS.
Atara Biotherapeutics Inc. and Pierre Fabre SA announced the approval of Tabelecleucel, a therapy for a rare and potentially fatal malignancy.
The European Council has adopted three regulations aimed at improving pandemic preparedness, which together with two other pillars complete the EU Health Union.