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...
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
