A multi-stakeholder EU workshop has helped identify how patient registries can support the benefit-risk evaluation of CAR-T cell therapies, given the challenges posed by these products, not least the need for the long-term follow up of treated patients.
The European Medicines Agency has issued several recommendations to help facilitate and improve the use of patient registry data to support the evaluation of chimeric antigen receptor T-cell (CAR T-cell) therapies.
The recommendations, which include introducing a method for the systematic collection of a set of core commonly-defined data elements, follow...
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Actions taken by the European Commission and European Medicines Agency to tackle critical shortages of medicines have not succeeded in practice and further systemic improvements are required to address supply issues, a report from the European Court of Auditors has found.
Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.
The sponsors of seven new medicines nearing the end of their EU regulatory review are due – or possibly due – to appear before the European Medicines Agency’s human medicines committee, the CHMP, to address remaining concerns about their marketing applications.
While the EU's draft good manufacturing practice guideline on pharmaceutical quality systems reflects modern quality management principles, it also presents significant operational and resource challenges for drug companies.
Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.
Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!
The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.
