Latest From Ian Schofield
The World Health Organization’s BioHub project is gathering momentum, with the spotlight on the equitable and timely sharing of viruses and other biological materials to develop medical products for use in future health emergencies such as a pandemic. But while its objectives are lauded by many, concerns have been raised about the intellectual property implications of the project.
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.
Proposals for averting medicines supply disruptions caused by Brexit in Northern Ireland and three EU markets are about to be discussed by EU legislators.
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.
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.