Consortium of 5 drug regulators plot path to increase harmonization through 2024
A group of drug regulators from Australia, Canada, Singapore, Switzerland and the UK on Tuesday unveiled their strategic plans for the next three years, laying out how they’ll work together on reviewing new drugs to reduce duplication across borders.
While understanding that the biopharma industry is truly global, the group, known collectively as the Access Consortium, seeks to better align their respective regulatory and policy approaches for pharmaceuticals, with an aim to facilitate faster access to high quality, safe and effective health products.
Through 2024 the consortium will seek to increase the number and variety of new drug applications that the regulators collectively assess, in addition to capturing lessons learned from the pandemic to improve their work-sharing processes.
In addition, the regulators will also explore collaborations with national health technology assessment organizations, which can inform reimbursement decisions.
The consortium also said, according to its new strategic plan, that it’s considering collaborative work on clinical trial designs and providing sponsors with mutual avenues for advice.
The group said it will gauge its success based on increases in products made available, reduced effort and duplication for industry and regulators, increased collaboration on manufacturing and clinical inspections, and by decreasing the average time to market for products assessed under the group.
The original consortium formed in 2007 with all of the regulators except for the UK’s MHRA, which joined last October.
MHRA is also now part of another overlapping group of regulators including the US FDA, Brazil’s ANVISA, the European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, and all of the members of the Access Consortium. The regulators work together on concurrent submissions and reviews of cancer drugs as part of what’s known as Project Orbis.
In April 2020, Seagen’s tucatinib in combination with trastuzumab and capecitabine was the first new molecular entity approved under the FDA-led group of regulators.