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

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...

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