UK Accelerates Review Times for Postmarket, Certain Phase 3 Trial Applications
Sponsors of postmarket trials and certain phase 3 trials can now expect the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to process their trial applications within two weeks rather than the statutory 30 days, as long as they meet certain criteria.
The accelerated review times, part of the UK’s efforts to revitalize its clinical research ecosystem and make conducting trials in the country more attractive to sponsors, apply to lower-risk postmarket trials and phase 3 trials. This accelerated process does not yet apply to phase 1 trials, phase 2 trials or protocol amendments, the MHRA noted.
“Clinical trials regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents,” June Raine, chief executive of the MHRA, said. “[This] will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety.”
For postmarket trials, two criteria must be met:
- The trial’s investigational product(s) must be licensed and used according to the relevant UK, U.S. or EU approval, except for placebo; and
- There must be no ongoing safety concerns regarding the investigational product(s) that the sponsor is aware of, such as other trials on clinical holds, other trials with unresolved urgent safety measures or postmarket regulatory restrictions.
Phase 3 trials must meet at least one of these criteria:
- The trial is already approved in the U.S. or EU based on the same protocol and investigator brochure submitted to the MHRA, and for the EU, the same version of the investigational medical product dossier. For trials solely approved by FDA, the dossier submitted to the MHRA must include the same investigational product manufacturing process.
- The MHRA has approved, in the past two years, a prior phase 3 trial of the investigational product(s) for the same (or higher) dose, dosing (or higher dosing) frequency and indication even if the trial was with a different sponsor. This trial must also have used the same investigational product manufacturing process.
- The investigational product(s) are approved and used according to the relevant UK, U.S. or EU approval, except for placebos.
In addition, accelerated review times do not apply to phase 3 trials with complex/innovative designs (such as basket, umbrella or platform trials) that allow for prospective major changes, pediatric patients, pregnant or breastfeeding participants, first-in-class investigational product(s), or investigational product(s) that are advanced medicinal products.
Register for the new review process here.