Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.
Plans for the overhaul of the EU pharmaceutical legislation have begun what will likely be a long and tortuous legislative journey after Florian Schmidt of the European Commission formally presented the proposals to the European Parliament’s environment and public health committee (ENVI) on 20 September.
The presentation covered all the key points of the revision, including plans to “modulate” regulatory data protection on medicines. However,...
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
