UK Regulator Calls For More Patient Involvement In Trial Design
More Flexible Rules On GCP And IMPs Are Planned
UK plans for a flexible and streamlined clinical trial regulatory regime are now out for consultation, covering areas such as investigational medicinal products, greater patient involvement in trial design, and lighter-touch oversight of low-intervention trials.
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In this second article on the post-Brexit fortunes of the UK medicines regulator, the MHRA, Pink Sheet looks at the emergence of a new UK clinical trials environment, how the agency is facing up to resource pressures, and when the new fee structure might be ready.
The UK regulatory agency, the MHRA, is planning to establish a “world-class sovereign regulatory environment” for clinical trials to support the development of new innovative medicines. In the first of two articles, we look at the MHRA’s proposals to slim down trial approval processes, lighten the safety reporting burden, and introduce greater transparency of trial registration and results.
When the new Clinical Trial Information System goes live at the end of January, it will usher in many practical and operational considerations that sponsors need to be aware of.