Europe

The legislation will establish a new EU platform for monitoring and reporting medicines shortages.

Big changes are in store at UK health technology assessment body NICE aimed at improving the way medicines are assessed.

Global regulators have been discussing how best to approach vaccination in the face of possible future coronavirus variants, and whether bivalent or multivalent vaccines could be the answer.

As well as recommending Seagen’s Tukysa and Daiichi Sankyo/AstraZeneca’s Enhertu, the Scottish Medicines Consortium has given the green light to Leo Pharma’s Adtralza and a new lung cancer indication for AZ’s Tagrisso. Meanwhile, Alexion has failed to make a submission to HTAs in both Scotland and England for a specific indication for Soliris.

The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.

UK plans for a flexible and streamlined clinical trial regulatory regime are now out for consultation, covering areas such as investigational medicinal products, greater patient involvement in trial design, and lighter-touch oversight of low-intervention trials.

The UK regulatory agency, the MHRA, is planning to establish a “world-class sovereign regulatory environment” for clinical trials to support the development of new innovative medicines. In the first of two articles, we look at the MHRA’s proposals to slim down trial approval processes, lighten the safety reporting burden, and introduce greater transparency of trial registration and results.

Days before the EU Clinical Trial Regulation is set to come into effect, a new initiative has been launched to track and support its successful implementation and help deliver other trial-related reforms. 

Chaos wrought by the ongoing coronavirus pandemic. A heavy workload and continuing resource constraints at the European Medicines Agency. Nonetheless, a record number of novel drugs and vaccines were cleared for marketing in the EU last year.

When the new Clinical Trial Information System goes live at the end of January, it will usher in many practical and operational considerations that sponsors need to be aware of.

An investigational CAR T-cell therapy that hospital researchers in Spain believe they could produce at a third of the price of commercially available CART19 products has been accepted onto the European Medicines Agency's priority medicines scheme.

Challenges to the use of real-world data and the importance of wider international regulatory collaborations were among topics addressed by the European industry body EFPIA in a survey of its member companies.