Latest from Eliza Slawther
The European Medicines Agency has given stakeholders until 18 December to give their opinion on its proposed platform for addressing gaps and research needs in regulatory science.
The pharma industry wants regulators around the world to engage with companies and “articulate the value added” when introducing new regulations and guidance around the use of AI in drug development, AstraZeneca’s director for data and AI policy says.
While many companies demonstrated an interest in the UK’s licensing and access pathway for innovative medicines, few made use of the various benefits the scheme had to offer, the MHRA said.
Global regulators should work together on producing standard terminology around the use of AI in drug development to align as much as possible on their approaches, according to the Food and Drug Administration’s Tala Fakhouri.
Experts working in the advanced therapy sector tell In Vivo how novel solutions can empower cell and gene therapy manufacturers to reduce costs, improve scalability and optimize their processes – improving the clinical profile and commercial viability of products.
The UK’s drug regulator, the MHRA, is exploring new opportunities to work closer with its counterparts from Australia, Canada, Singapore and Switzerland under the ACCESS Consortium group, with a focus on pre-submission scientific advice.