Eliza Slawther

It is “absolutely fundamental” that manufacturers of cell and gene therapies interact with inspectors from regulatory agencies to understand their expectations around good manufacturing practice, a compliance consultant at CDMO eXmoor pharma says.

Pharmaceutical companies should only use AI in evidence generation and reporting where there is “demonstrable value from doing so,” according to England’s health technology assessment body, NICE.

The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.

AI has the potential to save vast amounts of time and money by optimizing pharma supply chain processes, but companies must think about legal risk and liability from all angles, Ewan Townsend, partner at law firm Arnold & Porter, tells the Pink Sheet.

AI modeling can predict which animal tests are useful and necessary, saving money for companies and meeting objectives set by regulators in the US and EU, VeriSIM Life’s CEO and founder Jo Varshney tells the Pink Sheet.

While pharmacovigilance requirements for medicines in the UK will remain “broadly in line” with current rules from 1 January 2025, companies should be aware of changes for some products after this date, the UK’s MHRA says.

Rapidly-mutating viruses can easily outpace even the fastest vaccine developers. To prevent another pandemic, biotechs are hoping AI might be able to predict mutations of concern and design vaccines against them before they arise.

Pharmaceutical companies will be able to work with a newly-established network of clinical trial delivery centers and primary care providers in all four UK nations as part of a new public-private investment scheme.

Clinical trial sponsors could find themselves in hot water with EU regulators if they share data from non-EU patients under the upcoming European Health Data Space, warns a life sciences lawyer from Sidley Austin.

Medicines regulators in the EU have “much to gain” from using AI models in their processes, but this technology must be used in a “safe and responsible” way, says the European Medicines Agency.