Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.

Health Canada has proposed revised criteria that take account of patients' needs and the health care system when deciding whether to fast-track the review of a particular drug.

The World Health Organization has shortlisted over 30 quality assurance and good manufacturing practice guidelines that are over seven years old or need a major review.