1. Pink Sheet
  2. >>Advanced Technologies

ACCESS Consortium Expands Focus To ATMPs And ‘Urgently Needed’ Medicines

 
• By Eliza Slawther

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.

Gene therapies are one type of ATMP

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Cell & Gene Therapies

More from Advanced Technologies

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

US FDA’s Top Cell and Gene Therapy Regulators Forced Out

 
• By Sarah Karlin-Smith

Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.