Medicines regulation and law

MHRA eliminates backlog of medicines awaiting marketing authorisation

After resolving its backlog of medicines approvals, the Medicines and Healthcare products Regulatory Agency aims to adopt its tailored biosimilar UK licensing pathway as it does not need manufacturers to conduct confirmatory clinical trials.…

Online pharmacies to be inspected within six months of registration, says GPhC

The target for first inspections of new bricks-and-mortar pharmacies will be extended to 12 months.…

Ban on puberty blockers in the UK made indefinite, government says

Independent expert advice provided by the Commission on Human Medicines has urged that the ban continue while progress is made towards safeguarding children and young people.…

NICE recommends alternative corticosteroid for people with Duchenne muscular dystrophy

The guidance says that vamorolone reduces “adverse events” that are tied to other currently available corticosteroids, which include osteoporosis, weight gain and delayed puberty.…

Manufacturer offers NHS £23m in response to investigation into misleading claims about rival treatment

Vifor Pharma has also agreed to write to healthcare professionals to “correct any potentially misleading communications regarding the safety of Monofer and Ferinject”.…

UK medicines regulation disincentivising investment in research development, finds survey

The Association of the British Pharmaceutical Industry’s survey results accompany 12 recommendations for improving the Medicines and Healthcare Products Regulatory Agency’s effectiveness as a UK medicines regulator.…

Pfizer and Flynn Pharma fined £69m for ‘excessive’ pricing of epilepsy drug

The Competition Appeal Tribunal has upheld the Competition and Markets Authority's 2016 decision that Pfizer and its distributor Flynn “were gouging the market” when the pricing of phenytoin sodium capsules resulted in costs to the NHS increasing from £2m in 2012 to around £50m in 2013.…

Chief pharmaceutical officers say it is ‘entirely reasonable’ for pharmacists to take position on assisted dying bill

A joint statement warned that the outcome of the Terminally Ill Adults (End of Life) Bill must not undermine provision of good end-of-life care and work by palliative care clinicians.…

Weight loss drugs make up ‘very small’ proportion of illegal medicines trade in UK, says MHRA

The Medicines and Healthcare products Regulatory Agency highlighted that illegal weight loss medicines aren't a “substantial challenge” as the agency has made “900 or so seizures” of trafficked weight loss injections.…

NICE may be ‘systematically undervaluing’ medicines for severe conditions, says ABPI

The Association of the British Pharmaceutical Industry is urging the government and National Institute for Health and Care Excellence to “show greater flexibility when assessing medicines for severe conditions”.…