Diamond achieves first PRIME acceptance in Europe
Diamond achieves first PRIME acceptance in Europe on behalf of gene therapy client
Just two months after the EMA PRIME scheme was announced and after making a submission on the very first deadline available for access to the PRIME scheme, Diamond BioPharm Limited is pleased to have received one of the very first PRIME acceptances from the EMA's Committee on Advanced Therapies on behalf of a major gene therapy client.
With no precedent in these applications, this is yet another example of Diamond BioPharm Limited being at the forefront of groundbreaking regulatory activities.
"We are always pushing the regulatory envelope on behalf of our clients", commented Diamond BioPharm's Managing Director, Maureen Graham, "This is a major step forward for collaborative working between the regulators and industry and also a hugely important acknowledgement of our client's product by the Committee on Advanced Therapies."
Now accepted into the PRIME scheme, this client will benefit from early assignment of the rapporteur that will eventually review a marketing authorisation application for this product, early interactions with the agency including a kick-off meeting to facilitate the approval procedure and additional discussions with health technology-assessment bodies in order to get this product to patients quicker.
If you would like to join this client in receiving confirmed support from the agency through the PRIME scheme, please don't hesitate to contact us at:
Phone: +44 1279 441 616