A work-sharing group made up of regulators in Australia, Canada, Singapore, Switzerland and the UK has been expanded to include advanced therapy medicinal products, which could lead to greater harmonization in the regulatory approaches taken by different agencies.
The ACCESS Consortium, a five-strong international work-sharing initiative aimed at accelerating drug approvals, has been expanded to include a working group specifically focused on advanced therapy medicinal products (ATMPs) and a pilot pathway for urgently needed medicines.
A spokesperson for the UK’s MHRA, one of the five ACCESS Consortium members, told the Pink Sheet that ATMPs were...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.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.
