Discord Remains On EU Clinical Trials Transparency, Even Within Industry
This article was originally published in The Pink Sheet Daily
EU regulators, industry and researchers remain at odds on the level of transparency needed in clinical trials, despite a fast approaching deadline and efforts by EFPIA and PhRMA to break the diplomatic logjam.
You may also be interested in...
The EMA’s CHMP has given the nod to Sanofi’s Aubagio and Biogen Idec’s Tecfidera for multiple sclerosis, setting the scene for a European three-way battle with Novartis’ Gilenya in the coming months.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.
The EMA has recommended suspension of some 700 drug formations linked with Indian clinical trials company GVK Biosciences, but assures national agencies that this won’t result in shortages or safety issues.