UK to Streamline Trial Review Process, Accelerate Startup
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will institute a streamlined trial review process next year that will allow sponsors to submit a single application for both trial authorization and ethics committee approval.
Starting in January, all new trials of investigational medicinal products will undergo review by the MHRA, the UK Research Ethics Services and the Health Research Authority simultaneously, allowing sponsors to receive a decision from all three agencies at once.
The MHRA says several sponsors have tested the new process and in some cases reported a 30 percent improvement in overall trial start times.
Applicants are encouraged to begin using the new process now so they can align their internal procedures and systems before it takes effect in January.
Read instructions for the new process at https://bit.ly/3kH4Inq.