EFPIAPharmaceutical associations have responded with sharp criticism to the adoption of the revised general pharmaceutical legislation by the EU Council of Ministers in the form of a directive and a regulation. They argue that the measures are not suitable for bringing Europe back to the forefront of pharmaceutical research and will make the EU an unattractive location for investment.
Tag Archive for: regulation
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.