Regulators

EMA finds no link between GLP-1 receptor agonists and suicidal thoughts

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has confirmed that no update to product information is warranted.…

Government should consider ways to prevent ‘inappropriate overseas prescribing’ of hormone drugs, review recommends

The Cass review of gender identity services for children and young people has recommended the government work with the General Pharmaceutical Council to consider statutory solutions to prevent inappropriate overseas prescribing of hormone supplies.…

Pharmacy regulator consults on annual monitoring of pharmacy education providers

The General Pharmaceutical Council has launched a consultation on collecting yearly data, including student feedback, admissions and performance, from educational organisations.…

Roz Gittins: ‘The longer fitness-to-practise processes take, the longer registrants are left in purgatory’

As the new chief pharmacy officer for the General Pharmaceutical Council, Roz Gittins tells The Pharmaceutical Journal that she is bringing a fresh pair of eyes to the regulator’s fitness-to-practise process.…

Pharmacists must be able to refer young people with gender dysphoria for support, says regulator

Duncan Rudkin, chief executive of the General Pharmaceutical Council, has warned that a lack of clear referral routes could lead people to seek alternative options, such as unregulated products or private clinics outside of the UK.…

MHRA approvals miss targets by more than 100 days, data show

In January 2024, it took an average of 333 days for a regulatory decision to be made for a medicine under the national route for marketing authorisations, versus a statutory timescale of 210 days.…

UK government backs all recommendations made following review of bias in medical devices

Alongside recommendations on the use of AI devices in NHS healthcare, the review specifically calls for oximeter standards to be strengthened to ensure accuracy with darker skin tones.…

More than a fifth of community pharmacies have cut opening hours in one year

Exclusive: The most common drop in opening hours was between 2 and 4 hours per week, with some pharmacies reducing hours by more than 32 hours per week.…

MHRA reviewing safety of asthma drug as Yellow Card reports increase

The Medicines and Healthcare products Regulatory Agency is reviewing montelukast after there were 143 reports of psychiatric disorders associated with the drug in 2023.…

Entrustable professional activities: a new approach to supervising trainee pharmacists on clinical placements

Changes to General Pharmaceutical Council education standards mean there is an increasing need for meaningful placement experiences in which trainees can practise their skills and demonstrate competence. Entrustable professional activities are a valuable tool for trainees and their supervisors.…