The ACCESS Consortium, an international coalition made up of the regulatory agencies for Australia, Canada, Singapore, Switzerland and the UK, has outlined how its new “promise pilot” pathway will work in practice and which types of medicines are eligible for this assessment route.
How The ACCESS Consortium’s New ‘Promise Pathway’ Can Benefit Drugmakers
Pharmaceutical companies that develop new medicines for life-threatening or severely debilitating conditions could be eligible to file for a priority review in the five ACCESS Consortium member countries under a new pilot scheme.

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Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
The Australian Therapeutic Goods Administration proposed a narrower indication that Eisai rejected.
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Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.