Medicines regulation and law

Genetic ‘biobank’ version of Yellow Card scheme to be piloted by drugs regulator

Genetic data and samples from patients who have experienced adverse side effects to medicines will be stored in the biobank, which will be used to determine whether the reaction was the result of a genetic trait.…

United States, Japan and Australia added to UK fast-track medicines approvals list

Medicines approved in countries including Australia, Canada, Japan, Switzerland, Singapore and the United States will be eligible for the Medicine and Healthcare products Regulatory Agency's fast-track approval route in 2024.…

Government to ‘progress legislation’ on widening hub-and-spoke dispensing following consultation

The Department for Health and Social Care has said it is finalising a response to its consultation on proposed changes to hub-and-spoke dispensing.…

PJ view: Britain must chart a new path on medicines access

The UK is in danger of lagging behind other countries when it comes to access to new medicines — the government must act now to uphold improvements in patient care.…

‘A global outlier’: how drug firms are fighting back against UK tax increases

With the UK tax on net sales of branded medicines quadrupling over the past three years, medicine manufacturers warn it will affect access to new drugs and are threatening to withdraw — but are these empty threats?…

Government warned repeatedly to better regulate supply of drugs online after series of deaths

Exclusive: Analysis of coroner’s reports has revealed a decade-long pattern of deaths caused by overdoses from drugs supplied online, accompanied by warnings to the government that more may die without tighter restrictions.…

‘Pandemic of tragedy’: the deaths caused by gaps in online drug supply regulations

In the past ten years, multiple people have died after taking drugs they purchased online, with coroners warning that people will continue to do so without tighter regulations in place.…

Government plans to make nitrous oxide a controlled substance

Chris Philp, minister for crime, policing and fire, said the widespread availability of nitrous oxide, as well as a rise in reports of social and health harms from the substance, meant the government would control nitrous oxide under the Misuse of Drugs Act 1971.…

Testosterone for menopause: why women face difficulties accessing treatment

GPs and specialist menopause clinics are overwhelmed with demand for testosterone to treat low libido in post-menopausal women; however, there are still no products licensed for women in the UK, leaving them to 'guesstimate' doses using male formulations or being forced to pay privately.…

Complex and inflexible: the shortcomings of serious shortage protocols

Use of ‘serious shortage protocols’ dropped significantly in 2022, despite growing numbers of medicine shortages, leaving pharmacists calling for the system to be overhauled.…