hTEPs (human tissue-engineered products): "dedicated response within pharma framework needed"
This article was originally published in Clinica
If human tissue-engineered products (hTEPs) were to fall under the EU's medicinal products regime, subject to most of its requirements, then there would be serious concerns for the industry dealing with these technologies. But if the Commission is designing a dedicated and independent regulation that will introduce specific customised requirements to demonstrate the quality, safety and efficacy of hTEPs and other advanced therapies under a pharmaceutical regulatory umbrella, then there should be no reason to object.
You may also be interested in...
A few months after bringing AstraZeneca onboard as a partner, the turnaround at the Alderley Park-based firm is moving ahead, buoyed by a fresh financing.
2019 saw fewer revenue-boosting major acquisitions by top-tier medtechs. Companies that reported after the calendar year-end were the first to see the consequences of the pandemic on their annual figures.
In the wake of the COVID-19 pandemic and the ensuing economic fallout, pharmaceutical companies could face a range of measures designed to cut government spending on medicines. From relaxing intellectual property rights to delaying reimbursement, In Vivo examines what might be in store for industry.