The MHRA says its proposals for a new, tailormade regulatory regime for personalized medicines manufactured at the point of care are evidence of its “intent to move away from a common perception of regulators as a progress blocker to a progress enabler.”
The UK’s medicines regulator has proposed a new, unique framework to oversee the safety, quality and effectiveness of innovative medicines that are manufactured at the point of care (POC).
POC is an emerging area of innovation and the Medicines and Healthcare products Regulatory Agency said its proposed framework was...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
